Each new chapter in pharmaceutical innovation underscores a simple truth: the path from molecule to medicine is never linear. Scientific discovery, technological evolution, and market demands constantly reshape the landscape, requiring both agility and vision from every stakeholder. This issue of 

® captures the state of that journey, one that is as much about mastering fundamentals as it is about embracing new tools and approaches.

Our cover story, “The Evolving Science Behind Formulation Development,” explores strategies across the drug product lifecycle. Vaibhav Sihorkar, PhD, of Aragen Life Sciences, offers insights into problem solving, the role of digital tools, and how geopolitical change is influencing formulation decisions from a CRDMO’s perspective. The complex area of drug formulation is further explored in Cynthia Challener’s “Personalized and Patient-Centric Administration of Oral Medicines,” which highlights how individualized therapies are moving forward despite the challenges of scalability and regulation.

Ensuring product quality remains at the forefront. In our Ask the Expert feature, Michelle Heiter and Susan J. Schniepp outline best practices for implementing contamination control strategies that safeguard patient safety and regulatory compliance. Meanwhile, the Pharma Fundamentals article by Evonne Brennan reinforces the essential skills professionals need to thrive in this rapidly changing field.

At the critical stage of technology transfer, “Emerging Tools, Integrated Controls Impact Tech Transfer” highlights how smarter systems can streamline the transition from lab to production. In advanced therapies, “Optimizing Testing in Cell and Gene Therapy” underscores the need for agile, compliant testing methods that can keep pace with accelerated development timelines. On the manufacturing front, Susan Haigney’s “Keys to Navigating the Complex Drug Supply Chain” shows how digital tools help manufacturers adapt to ongoing global volatility.

As a whole, this issue reveals an industry strengthening its foundation while embracing innovation. Success now demands not just advanced tools and processes, but collaboration, resilience, and a focus on improving outcomes for patients worldwide.

Mike Hennessy Jr is Chairman and CEO of MJH Life Sciences®.

When referring to this article, please cite it has Hennessy, M. Building Resilience and Precision in Pharma Development. 

Articles

Pharmaceutical innovation is a complex journey shaped by scientific discovery, technological evolution, and market demands. This issue examines the evolving science of formulation development, emphasizing problem-solving, digital tools, and geopolitical influences. Personalized oral medicines face scalability and regulatory challenges. Contamination control strategies are crucial for product quality and regulatory compliance. Technology transfer benefits from integrated controls, while cell and gene therapy testing requires agile methods. Digital tools aid in navigating the drug supply chain amid global volatility. Success in the industry hinges on collaboration, resilience, and patient outcome improvement.

From the Chairman

Scientific discovery, technological evolution, and market demands are constantly reshaping the landscape.

Building Resilience and Precision in Pharma Development

The pharmaceutical supply chain is a complex ecosystem consisting of procurement, ingredients suppliers, contract manufacturers, regional regulations, temperature controls, and track and trace technologies. This ecosystem is highly impacted by facility quality deficiencies, which can delay manufacturing and create drug shortages (1). The threat of anticounterfeit drugs is also a spoke in the wheel, with technologies and regulations working together to safeguard patients (2).

“The pharmaceutical supply chain is like a global relay race involving suppliers, manufacturers, distributors, pharmacies, and regulators,” explains Dr Damodharan Muniyandi, chief quality officer–Global Quality & Regulatory Affairs at Sai Life Sciences. “Complexity tends to arise from sourcing APIs and excipients worldwide, meeting diverse regulatory requirements, managing cold chain logistics for biologics, and tackling counterfeit risks. To navigate this complexity, companies are turning to digital supply chain platforms, predictive analytics, and multi-tier supplier networks for resilience. Quality-by-design and continuous manufacturing help maintain consistency, while cross-border regulatory harmonization builds transparency and agility. It’s about blending smart technology with robust partnerships to keep medicines moving safely and efficiently across the globe.”

Integrated digital systems offer real-time visibility and ensure compliance, according to John DiPalo, chief strategy officer for ACSIS, part of Antares Vision Group. “Technologies like serialization and centralized data platforms help manufacturers track product movement, spot irregularities, and quickly respond to issues, protecting patients and preserving brand reputation,” he says.

“Digital technologies—RFID [radio frequency identification], IoT [Internet of Things], and AI [artificial intelligence]—transform fragmented processes into a transparent, resilient, and responsive network, enabling accurate demand planning, reduced waste, and better service levels,” concurs Grethe Bonde, marketing communications specialist at Murata.

Pharmaceutical companies establish quality control departments to manage supply chain issues, according to Sundar Narsimhan, chief procurement officer, Neuland Laboratories Limited. These departments follow guidelines, such as those established by the International Council for Harmonisation (ICH) and local regulatory agencies.

Differing political and regulatory climates can make managing a drug supply chain even more complex. “In the current context, the volatile geopolitical situation coupled with unprecedented tariff escalations and new drug price prospecting have elevated this to a new level,” says Narsimhan.“We are witnessing a real fragile supply chain situation as we speak.”

Sticking to the basics and a commitment to enduring relationships with supply chain stakeholders is key to navigating this ever-changing situation, according to Narsimhan. “Given the scale of damage that loss of business or customers can cause, keep your calm and a watchful eye on the daily developments, such as tariffs, customer and supplier voices, and demand and inventory data,” he advises. “Take very well-thought-out positions on price, concessions, cost-sharing, and commitments for the short-term, keeping in mind that this situation will not last forever. Finally, be very agile and alert to make changes in response to emerging situations—on shipment routing, inventories, and so on.”

The country-to-country variety in regulations from government and standard-setting organizations adds to the complexity of the supply chain. “Fragmented regulations can lead to unexpected compliance issues, product recalls, or halted shipments,” Sade Mokuolu, PhD, regional business development manager, life sciences, Watson Marlow Fluid Technology Solutions, states.

A common regulatory language and standardized regulations enhance supply chain security, says Bonde. “Global standards, like GS1 for product identification and serialization, reduce errors and fraud. In the EU, the Falsified Medicines Directive (FMD) is a prime example: it mandates unique identifiers, tamper-evident features, and verification through the European Medicines Verification System (EMVS). This harmonized framework prevents counterfeit medicines from entering the legal supply chain, strengthens traceability, and ensures consistent product authenticity and quality across markets,” she says.

“Standardized rules foster clearer communication between manufacturers, suppliers, regulators, and consumers,” Mokuolu agrees. “This transparency strengthens relationships across the supply chain and supports responsible product stewardship.”

“Organizations such as ICH, PIC/S [Pharmaceutical Inspection Co-operation Scheme], and WHO [World Health Organization] are driving this harmonization of GMP [good manufacturing practice] standards, making audits easier and compliance less costly. The result is a supply chain that’s more transparent, more trusted, and far better equipped to keep medicines moving quickly and safely from manufacturer to patient, no matter where they’re made,” agrees Muniyandi.

A shared framework for complying with different global supply chain regulations that includes data exchange, product serialization, and traceability is necessary, according to DiPalo. “This consistency allows smooth interoperability among global partners, simplifying compliance and improving visibility and accountability throughout the supply chain,” he explains.

Regulators have been making headway on securing the drug supply chain in recent years. In August 2025, FDA created a new program to decrease US reliance on foreign manufacturers. The FDA PreCheck Program will have a two-phase approach to the development of new manufacturing facilities in the US, allowing manufacturers to communicate more directly with the agency on things like facility design, construction, and pre-production. It will also streamline the development of the chemistry, manufacturing, and controls section of a drug application through pre-application meetings and feedback (3).

The European Medicines Agency (EMA) is dealing with drug shortages by focusing on specific areas. In July 2025, the agency issued recommendations for securing the supply of anti-D immunoglobulins used to prevent RhD immunization during pregnancy in the European Union (4). And in April 2025, EMA published recommendations to strengthen the supply chain of radiopharmaceuticals (5).

Recent political impacts have also added to the complexity of the drug supply chain. The Trump administration’s changing tariff policies in the US have forced companies to reassess their supply chains and operations (6), and the flow of APIs and raw materials has been disrupted.

Jason Waite, an international trade expert at Alston & Bird, stressed that pharmaceutical companies should build cross-functional trade compliance teams in response to rising global trade tensions—particularly potential Section 232 tariffs. Compliance regarding product origin, classification, and valuation, must occur early in R&D and manufacturing to avoid downstream disruptions, he said in an interview with Pharmaceutical Technology®. He also emphasized proactive communication between R&D, finance, logistics, tax, and trade departments to help successfully navigate trade policy changes (7).

Best practices to secure the supply chain

Performing best practices can help minimize disruptions brought about in the manufacturing process. Strict GMP adherence on the shop floor can ensure quality, says Muniyandi, as can using process analytical technology to perform real-time monitoring, validating equipment, and properly training staff. “Machine learning can spot potential quality issues early, optimize processes, and keep batch cycle times under control. IoT sensors enable predictive maintenance to prevent breakdowns, while IoT-enabled logistics track environmental conditions and location once products leave the plant,” he says. “Together, these measures create a clear chain of custody.”

Strong in-line quality controls are key, says DiPalo, specifically machine vision inspection, leak detection, and material verification. “These systems lay the groundwork for the simultaneous use of unique serial numbers and aggregation management, which enables unit-level tracking with serial numbers and aggregation codes,” he says. “Combining this with data from a reliable serialization platform provides complete traceability from manufacturing to the patient, allowing quick responses to recalls, theft, or diversion. These steps together ensure both quality assurance and complete visibility.”

“In manufacturing, quality is ensured through in-process controls, environmental monitoring, and process validation, while traceability is achieved via unique serialization and aggregation,” Bonde says. “RFID and IoT sensors create digital product passports, tracking each unit’s journey and monitoring critical parameters, such as temperature and humidity, in real time. This enables rapid recalls, minimizes waste, and ensures compliance up to the point of care.”

When it comes to using automated inspection systems in the pharma industry, Eran Sinbar, CEO of Yoran Imaging, stresses that they be performed non-invasively and in a way that links inspection data to unique product identification, “two key reasons that thermal imaging-based inspection is beginning to make inroads.”

Utilizing supplier quality management provides a structured approach for ensuring materials, components, and services received by third-party suppliers meet quality and regulatory standards, says Mokuolu. “For drug products that utilize single-use technologies, establishing a consistent set of compliance information across all single-use suppliers enables drug manufacturers to make more accurate comparisons and ensures confidence in dual sourcing strategies,” she continues. “When compliance criteria are open to interpretation, it becomes difficult to assess supplier equivalency.”

Technologies used in the protection of the small-molecule supply chain include tamper-evident packaging and integrated track-and-trace systems that are connected to such platforms as enterprise resource planning and warehouse management systems, according to Bonde. Additional measures are required for biologics, she stresses, such as IoT-based cold chain monitoring, cloud-connected data loggers and blockchain/distributed ledger technology.

Antares Vision Group Life Science uses serialization, aggregation, and automated machine vision inspection in its operations to ensure a secure supply chain for small molecule drugs. For temperature-sensitive large molecules, the company uses real-time cold chain monitoring and RFID-based tracking for reusable assets.

Regarding packaging technologies, Sinbar is seeing increased interest in thermal imaging-based inspection, which Sinbar says gives verifiable, reportable proof of seal integrity and valuable production performance data.

“For small molecules, supply chain security often relies on scale and future-proofing strategies, such as flow chemistry, enzymatic synthesis, short cycle (including greener) synthesis using breakthrough reactions, and derisking strategies, such as supply base and geographic diversification, along with prioritizing reliable partners over mercurial ones,” says Narsimhan.“For large-scale molecules, backward integration is key: adopting novel synthesis methods alongside traditional synthesis, securing raw material supplies despite the geographic concentration, and—if outsourcing—choosing the right supply partner after due diligence for long-term cooperation, since de-risking is often expensive and switching suppliers carries high costs.”

AI is increasingly being utilized in the pharmaceutical industry for supply chain security including automating quality control processes, tracking changing global regulations, predictive analysis for risk detection, counterfeit identification, optimizing logistics, and anomaly detection. According to Sinbar, Yoran Imaging uses AI for big data analysis, root cause investigation, and predictive maintenance. “AI adoption should continue to expand to improve responsiveness, reduce human error, and support real-time decision making,” Sinbar says.

“However, [AI’s] broader adoption is limited by fragmented datasets, lack of interoperability, and regulatory constraints,” Bonde advises.“When integrated with IoT and RFID, AI can proactively reroute shipments, optimize inventory, and identify threats before they cause disruptions.”

AI offers quicker and more accurate detection of problems within the supply chain ecosystem, according to DiPalo, and can drive predictive analytics for managing found risks. “For example,” offers DiPalo, “Antares Vision Group’s AI-GO platform uses deep learning for precise defect detection and adaptive process control, helping to enhance safety, quality, and efficiency throughout the supply chain.”

“By leveraging supplier management tools, organizations can collect and analyze performance data from each supplier,” says Mokuolu. “Integrating machine learning and artificial intelligence enables deeper insights into supplier reliability and operational trends. These technologies help proactively identify potential risks and disruptions, effectively future proofing the supply chain.”

“Challenges [to AI adoption] include high implementation costs, a shortage of skilled talent, data silos, and regulatory uncertainty,” says Muniyandi. “Even so, AI should play a bigger role. It can dramatically boost resilience, efficiency, and security—critical in a post-COVID world in which supply chains must be faster, smarter, and more adaptable than ever.”

A variety of AI tools have entered the chat. In April 2025, SkyCell partnered with Microsoft to integrate SkyMind, SkyCell’s AI-powered supply chain solution, with Microsoft Teams and Copilot based on Azure OpenAI Service. The collaboration will enable those working in the pharmaceutical supply chain to access real-time shipment data, predictive insights, and automated alerts within a Microsoft system, according to SkyCell (8).

The drug supply chain’s many facets allow for multiple avenues for a negative impact on the patients who need medications to live a quality life. Disruptions in the supply chain can stem from such regional problems as natural disasters, quality problems at manufacturing facilities, and political discourse. These disruptions are often out of a drug company’s control. Drug manufacturers should control what they can to minimize these problems by following GMPs and employing the best tools for ensuring quality.

FDA. Drug Supply Chain Security Act (DSCSA). 

FDA. FDA Announces New FDA PreCheck Program to Boost US Drug Manufacturing. Press Release. Aug. 7, 2025.

EMA. Strengthening Supply Chain of Anti-D Immunoglobulins. Press Release. July 4, 2025.

Barton, C. EMA Is Tackling Vulnerabilities in the Supply Chain of Radiopharmaceuticals. 

Cole, C. Survey: Impacts of Tariffs and Trade Policy on the Bio/Pharmaceutical Industry. 

Cole, C. How Pharma Can Build Resilient Supply Chains Amid Trade and Tariff Shifts. 

SkyCell. SkyCell and Microsoft Announce Collaboration to Bring Copilot into Pharma Supply Chains. Press Release. April 7, 2025.

®
Vol. 49, No. 7
September 2025
Pages: 22–25

When referring to this article, please cite it as Haigney, S. Keys to Navigating the Complex Drug Supply Chain. 

The pharmaceutical supply chain is a multifaceted ecosystem involving procurement, manufacturing, and distribution, heavily influenced by regulatory and geopolitical factors. Quality deficiencies and counterfeit threats pose significant challenges, necessitating robust digital technologies and regulatory harmonization for resilience. Integrated digital systems, AI, and IoT enhance transparency, compliance, and predictive capabilities, while standardized regulations improve security and traceability. Political and regulatory complexities further complicate supply chain management, requiring agile strategies and strong partnerships. Ultimately, ensuring supply chain integrity is crucial for patient safety and maintaining drug availability.

Manufacturing

Digital solutions help pharmaceutical manufacturers navigate the complex supply chain.

Keys to Navigating the Complex Drug Supply Chain

It is important to learn and continue learning.

While context is essential, hearing different perspectives enhances clarity. It strengthens validation of what is known and supports learning if it’s not. Information flows at us in many forms of printed, digital, or in-person meetings. However, with this information overload, there still exists a unique challenge: time; it continues its angst, causing a gap in fundamental knowledge. This can impact negatively in reasoning and even more so if questioning does not feel encouraged. Retention is another consideration. Memory can lapse from not utilizing knowledge; there are times when you are only as good as your last project, and sometimes one needs to reactivate the neural pathways.

In response to the perceived need for continued learning in the industry, 

Editorial Advisory Board (EAB), along with the editorial team, decided to help keep our readers activated by selecting central topics, all within the construct of the magazine’s focus, to assist with learning while perusing the monthly print issue and digital content available on 

. I am happy to lead the topics of development and manufacturing in this task (stay tuned, its coming soon), and with such diverse expertise within the EAB, we are happy to take this journey with you.

While a broad subject area, the development segment will encompass five key topics: pre-formulation, formulation, scale-up, and post-formulation. Initially, with pre-formulation, such subtopics as drug discovery will be explored as we look at its process and where the industry is today. The well-known image showing the stages of the drug discovery process carrying its hefty price tag of approximately $1 billion along with the time taken to market will resonate well here. Considering the wider audience, this article series will visit the alternate stages in bringing a generic drug to the market. The complexity of a drug can impact time and cost, as more R&D work is needed to meet bioequivalence.

Pharmacokinetics (ADME [absorption, distribution, metabolism, and excretion]) grips efficacy and safety of medicines. It is the way one understands how a drug will behave in the body, its complexities and mechanisms of delivery, and where underlying illness and stubborn gastrointestinal challenges can impact performance.

Clinical trials are a significant cost in the development process; therefore, this series will cover its growing complexity, the dreaded placebo effect, and running trials in today’s climate, especially with the shift to decentralized trials. While medicine prices remain questionable, and in a variable state, the cost of bringing a drug to market is high. The specific cost of trials is challenged with potential losses and the realization that, unfortunately, not all will be successful.

Drug delivery and experimental design are significant fields in drug formulation, given the multifaceted subtopics and typical approaches. While newer technologies exist and there have been updates in design and function, standard technologies and their relevance to the industry today will be evaluated. As drug solubility is challenged, complexity arises, but there is support, with shared information, through research, and an added foresight of success when a drug is already marketed.

The quality-by-design pathway will be discussed, including considerations on API, excipient, and process characteristics, and ultimately, developing a robust dosage form delivering its target product profile. Moving from batch to continuous manufacturing, developing a new dosage form, or switching manufacturing processes requires a good design. Decisions, such as choice of excipient, could impact success. Patient centricity has been advancing in the industry, and while other factors exist, developing a suitable dosage form can influence continued patient uptake and adherence.

Following on from formulation development and success at the bench, scale-up is a challenging phase in development and manufacturing. The fundamentals series will cover considerations in scale up and possible change protocols as one moves from pilot stage to manufacturing and troubleshooting.

While cost features heavily in all earlier sections, it can significantly show its effect in the segment on post-formulation, where we will discuss topics covering improvements, stability, Phase IV, and lean manufacturing. Sometimes these learnings will resonate with that wonderful term “hindsight” and could aid in future decision making. Time and speed to market continue to challenge excellence and cost.

Regulatory topics will feature prominently in this series. Decision making can be impacted due to the regulatory route and delays. Also, quality, particularly as analytical testing has advanced, has its consequential impact on a risk-averse landscape.

As we take this journey, we would also like to hear from you! If there are any topics you find challenging or any experiences you would like to share, we welcome your thoughts/comments. Send comments and questions to 

Evonne Brennan, evonne@evonnebrennan.com, is an experienced educator and consultant delivering tailored tuition and courses in pharmaceutical formulation and processing. Evonne is a member of 

®
Vol. 49, No. 7
September 2025
Pages: 20–21

When referring to this article, please cite it as Brennan, E. Focusing on the Fundamentals of Formulation. 

Development

This article previews some formulation topics discussed in the Pharma Fundamentals series, which aims to enhance learning for professionals in pharmaceutical drug development and manufacturing.

Focusing on the Fundamentals of Formulation

Q. What is a contamination control strategy (CCS) and how does it support sustainable compliance and continuous improvement?

 A CCS is required in pharmaceutical manufacturing to ensure product safety, regulatory compliance, and efficient operations. The updated EudraLex, Volume 4, Annex 1 (1) mandates a CCS for sterile manufacturing in the European Union, aligning with similar FDA requirements
(2, 3) in the United States, as well as International Council for Harmonisation (ICH) Q9 Quality Risk Management (4) and ICH Q10 Pharmaceutical Quality System (5) guidelines.

A review of FDA 483s and FDA Complete Response Letters (CRLs) highlights areas for improvement in pharmaceutical manufacturing. Citations have been issued for deficiencies related to microbial contamination, environmental monitoring, and aseptic practices. Addressing these observations is required for drug approvals and to strengthen a CCS.

A CCS is a holistic approach to minimizing contamination by evaluating good manufacturing practices (GMPs). A CCS provides a proactive method for identifying, controlling, and scientifically evaluating quality risks designed to reduce contamination and enhance product safety and quality.

Elements of a CCS include the following (6):

Monitoring controls—personnel, in-process, materials, environmental, utilities, and pest controls

Validation controls—qualification/requalification of personnel, process, analytical methods, facility, utilities, and equipment

Contamination controls—personnel training, hygiene and gowning, process design, vendor material, consumable containers, equipment design, cleaning and sanitization

Quality risk management and risk assessment identify potential contamination sources and assess their impact on product quality and safety

Scientific and technical knowledge to prevent contamination

Personnel management to empower personnel through training. Staff education, awareness, and skills play a crucial role in maintaining contamination control.

A strong CCS serves as an invaluable quality tool, ensuring regulatory compliance while safeguarding product quality, safety, and enhancing the company’s reputation. Let’s embrace its power!

Q. Why is a risk assessment required for a CCS?

Conducting a risk assessment is critical for a successful CCS. It helps to proactively identify contamination sources and their effects, enabling implementation of targeted preventative measures that safeguard both products and the well-being of patients.

Identify hazards and risks before they turn into real problems.

Prioritize control measures based on the severity and likelihood of each risk to enable the allocation of resources to the areas vulnerable to contamination.

Regulatory compliance and a commitment to product quality and safety are essential for meeting regulatory standards in our industry.

Fostering continuous improvement by gathering insights, streamlining processes, and embracing innovative technologies. A proactive approach reduces risks and drives growth. This approach enables us to maintain control at every stage of the product lifecycle.

Encouraging a culture of safety that involves cross-functional team members in the risk assessment process. This approach helps everyone understand and take responsibility for contamination control.

A robust CCS begins with a risk assessment. By proactively identifying and addressing contamination risks, we improve product quality, prioritize patient safety, and confidently meet regulatory standards.

EudraLex–Volume 4–Good Manufacturing Practice (GMP) Guidelines

: Annex 1–Manufacture of Sterile Medicinal Products (2022 revision).

 Title 21, Parts 201 and 211. Current Good Manufacturing Practice for Drugs. 2023.

Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing

Chakraborty, S. and Baseman, H. Contamination Control Strategies: A Path for Quality and Safety. 

, May 8, 2022, pda.org/pda-letter-portal/home/full-article/contamination-control-strategies-a-path-for-quality-safety (accessed Jul. 21, 2025).

Michelle Heiter is laboratory and quality control specialist at Regulatory Compliance Associates, a Nelson Labs Company.

Susan J. Schniepp, is distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company.

®
Vol. 49, No. 7
September 2025
Page: 34

When referring to this article, please cite it as Heiter, M. and Schniepp, S. Effectively Using Contamination Control Strategies.

A contamination control strategy (CCS) is essential in pharmaceutical manufacturing to ensure product safety, regulatory compliance, and operational efficiency. It aligns with EU and US regulations and ICH guidelines, focusing on minimizing contamination through good manufacturing practices. Key elements include monitoring, validation, contamination controls, and personnel management. A risk assessment is crucial for identifying and prioritizing contamination risks, fostering continuous improvement, and maintaining regulatory compliance. A robust CCS enhances product quality, patient safety, and company reputation by proactively addressing contamination risks.

Ask the Expert

Michelle Heiter, laboratory and quality control specialist, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company, discuss how to effectively use contamination control strategies in your operations.

Effectively Using Contamination Control Strategies

Bringing new chemical entities (NCEs) from discovery all the way to the clinical trial stage requires deep knowledge in drug substance characterization, phase-appropriate formulations, and analytical development, not to mention the requisite technical capabilities necessary to deliver results that are at the same time tangible, practical, and innovative, all based on that expertise.

This article provides insight from Vaibhav Sihorkar, PhD, vice-president and Business Unit Head, Formulation Solutions at Aragen Life Sciences, about a world of new drug development he characterizes as dynamic and complex, while defining the range of services that a partner acting as a onestop solution can smoothly provide during the discovery to development pharmaceutics journey.

According to Sihorkar, contract research, development, and manufacturing organizations (CRDMOs) such as Aragen can offer a continuum of services to discovery clients from early discovery to the chemistry, manufacturing, and controls (CMC) process to clinical manufacturing. A CRDMO that has expertise in pre-formulation and formulation ideally can provide essential services that advance assets from lead identification through to clinical candidate selection.

“This includes pre-formulation strategies, such as selecting the optimal salt form, solid-state characterization (including polymorph screening), and improving solubility and oral bioavailability,” Sihorkar says, also adding excipient compatibility studies to this list. “The higher exposures needed for regulatory toxicity studies in preclinical rodent and non-rodent species are not only required to set the context for future human clinical doses but also help determine whether the NCE under consideration is developable and CMC-enabling, or CMC-challenging.”

Expanding on this theme, Sihorkar notes that whether a molecule in question is CMC-enabling or CMC-challenging, the CMC capabilities of a leading CRDMO should be designed to handle both. A holistic integration model, covering drug substance and drug product development alike, can ensure that formulation decisions are equally driven by scientific understanding and a seamless method of operational execution.

“Technologies such as spray drying allow for scalable formulation development from R&D to GMP [good manufacturing practice] manufacturing. These technology solutions are applied even to the most difficult compounds, including poorly soluble molecules known as ‘brick dusts,’” says Sihorkar, listing spray drying as one of Aragen’s key enabling technologies that works to overcome certain formulation challenges for poorly soluble NCEs. “A thorough evaluation of drug–polymer miscibility and drug loading is conducted to ensure molecular-level dispersion, as polymers play a critical role in stabilizing the amorphous drug. This stabilization reduces molecular mobility and increases the glass transition temperature, providing favorable viscoelastic behavior and enhancing resistance to devitrification and recrystallization.”

Robust clinical drug product development, phase-appropriate analytical method creation, and clinical batch manufacturing including supplies for Phase I and II trials are offerings that can support clients’ needs, Sihorkar says, with insights from the entire development cycle—from pre-formulation to a developability assessment to identify clinical drug product strategy.

Sihorkar says that as NCEs progress to the first-in-human stage, companies design clinical drug product strategies to support Phase I and IIa studies, ensuring that drug products meet necessary specifications for manufacturability, stability, and quality.

“As the molecule advances through clinical development, we continue to optimize formulations for [Phase IIb and III] studies to enhance robustness and scalability, ensuring continued success in the clinic,” Sihorkar says. “These strategies may range from simple approaches like drug-in-bottle (DiB), drug-in-capsule (DiC), and conventional blends in capsules or tablets to more complex formats. such as multiparticulate, spray-dried, or roller-compacted, uncoated or coated solid dosage forms. These strategies are well-supported by phase-appropriate, validated analytical methods.”

Here again, Sihorkar says, an integrated development model can provide a fast, reliable path through CMC, with a full spectrum of support that allows clients to de-risk clinical entry and accelerate their timelines.

At the moment, Aragen says it is seeing the most activity in development and manufacturing, with client demand growing specifically for strategic formulation planning at some of the earliest points in the development cycle. Sihorkar says this is especially true when it comes to investigational new drug-enabling studies.

However, at the risk of stating the obvious, it should be noted that not all formulations are created equal.

“Indicators of a stable formulation include limited molecular mobility within the polymer matrix, strong drug–polymer interactions, and the absence of drug-rich domains that can act as nucleation sites for crystallization,” Sihorkar explains.

Optimizing spray drying parameters through design of experiments (DoE), Sihorkar says, can help control particle morphology, residual solvent content, and process yields. Each of these parameters influences physical stability and scalability in some way.

“Predictive tools, such as molecular dynamics simulations, can quantify diffusion coefficients and interaction energies to forecast maximum stable drug loading and identify potential pre-crystalline sites, offering early warnings of instability,” Sihorkar says. “Additionally, environmental factors like temperature and humidity must be carefully managed post-production to avoid plasticizing and crystallizing the amorphous solid dispersion (ASD).”

The integrated strategy of combining a mechanistic understanding of molecular mobility with advanced characterization and process control, according to Sihorkar, can help to ensure development of robust, stable ASDs that maximize poorly soluble NCE bioavailability.

In addition, such advanced technologies as atomic layer deposition (ALD)—a thin-film coating process—may assist in coating challenging compounds. ALD is typically used, Sihorkar says, to achieve precise, uniform, conformal coatings at the atomic scale, enhancing solubility, dissolution, and stability.

Certain hurdles are known to exist for complex molecules that may have, for instance, poor solubility, high dosage requirements, or stability concerns. Sihorkar says some of the tools, expertise, and technologies a company may leverage to address a particular compound’s biopharmaceutical and physical properties may include spray drying, nanosizing, hot-melt extrusion, lipid-based systems, multiparticulates, or long-acting injectables.

“For example, in the case of amorphous solid dispersions, we utilize knowledge such as thermal behavior, glass-forming ability, and understanding of glass transition and viscoelastic properties to ensure effective selection of polymers for dispersion and stability,” Sihorkar notes. “DoE methodologies are further employed to fine-tune parameters critical to scale-up, such as glass transition temperature elevation, stability from devitrification, particle size, and morphology.”

Meanwhile, micro- and nanotechnologies play pivotal roles, Sihorkar explains, in drug product development for poorly soluble NCEs, in terms of enhancing bioavailability and formulation performance, enabling production of fine, uniform particles or nanosuspensions that increase—by significant margins—surface area and dissolution rate, facilitating improved absorption whether a dosage form happens to be oral or injectable.

Some of the specific technologies commonly deployed in this realm include air jet milling, nano-milling, or high-pressure homogenization.

“Air jet milling offers a solvent-free, scalable approach to micronization, while nano-milling and high-pressure homogenization provide robust methods to achieve stable nanoscale dispersions with enhanced physical stability and controlled release profiles,” says Sihorkar. “Integrating these technologies early in drug development allows formulators to overcome solubility challenges, optimize pharmacokinetics, and ultimately deliver more effective therapies for difficult NCEs.”

Sihorkar adds that CRDMOs can be of use in tackling challenges of peptide formulation development, like proteolytic degradation and physical instability. In these cases, a CRDMO will design specialized strategies for improving oral bioavailability or enhancing absorption through alternative routes. The technologies that are typically offered in this area include nanostructured lipids, solid-lipid nanoparticles, liposomes, coated systems, or other types of approaches that enhance permeability.

Troubleshooting and rise of digital tools

Ensuring dependable workarounds for poorly soluble NCEs is an issue for which CRDMOs can plan their approach. But what about, for instance, when a compound consistently fails to achieve desired systemic exposure? That is a scenario in which Sihorkar says Aragen recently found itself with one of its clients, and it required a dedicated problem-solving effort.

With this particular compound, Sihorkar explains, prior attempts had been made by previous partners at micronization, nanosizing, and spray-dried dispersion. The properties of the molecule were reevaluated using a detailed molecular pharmaceutics approach and solid-state characterization, ultimately selecting an optimized polymer matrix that enhanced glass transition temperature and prevented crystallization.

From there, an improved spray-drying process helped reformulate the compound, achieving a greater than threefold increase in preclinical exposure and enabling the client to progress with regulatory toxicity studies and clinical manufacturing.

Other novel approaches to troubleshooting, as listed by Sihorkar, could include atomic layer deposition, lipid nanoparticles, and second-generation long-acting injectables to address, respectively, challenges of solubility, stability, and release.

It is in the development of things like long-acting injectables or stable peptide formulations where Sihorkar states that the collective mindset of an integrated CRDMO can ultimately prove to be of particular importance.

“These efforts culminate in a pharmaceutical developability assessment, which blends physicochemical properties, solid-state characteristics, biopharmaceutics, and excipient compatibility to ensure manufacturability for clinical studies,” he says.

But other items in the CRDMO toolbox can speed up separate elements of clinical drug product manufacturing, like decision-making and process optimization. Increasingly, this has meant such digital tools as predictive modeling, data-led formulation design, and digitized batch execution. Sihorkar says these approaches can improve efficiency, reduce cycle times, and engender a higher degree of reliability in product delivery.

Sihorkar concludes that companies partnering on formulation strategies must keep abreast of geopolitical developments. In the United States in 2025 specifically, that means not only changes to tariff policies enacted by President Donald Trump, but also ongoing congressional considerations of the BIOSECURE Act.

To be as proactive as possible about this, Sihorkar says, Aragen has recently introduced a dual-sourcing model by which critical raw materials—APIs and inactive ingredients alike, specialty excipients, consumables, and certain packaging, for instance—are provided by a number of suppliers in varying global locations.

Along with expanding vendor networks and enhancing digital supply chain monitoring systems, these are ways in which companies may look to mitigate risk in the current geopolitical climate. And not only that, according to Sihorkar, but taking steps such as these helps to ensure compliance as well as continuity in both clinical and commercial programs.

The unique combination of technical and domain expertise, plus cutting-edge technologies, that CRDMOs are able to provide affords the opportunity for end-to-end client solutions for NCE development, according to Sihorkar. For those clients, the ideal outcome is that their assets are supported effectively at each distinct stage of the drug development journey.

®
Vol. 49, No. 7
September 2025
Pages: 10–13

When referring to this article, please cite it as Lavery, P. The Evolving Science Behind Formulation Development. 

The development of new chemical entities (NCEs) involves complex processes requiring expertise in drug characterization, formulation, and analytical development. Contract research, development, and manufacturing organizations (CRDMOs) like Aragen Life Sciences offer comprehensive services from discovery to clinical trials, addressing challenges such as solubility and stability. Advanced technologies, including spray drying and atomic layer deposition, enhance formulation performance. Digital tools and a dual-sourcing model help mitigate geopolitical risks. CRDMOs provide end-to-end solutions, ensuring effective support for NCE development at every stage.

Cover Story

This comprehensive overview of contemporary formulation strategies covers the drug product lifecycle from end to end, illustrating best practices for various formulation types seen through a CRDMO’s lens while also covering problem solving, the role of digital tools, and geopolitical changes.

The Evolving Science Behind Formulation Development

As personalized, life-saving treatments advance with the widespread adoption of cell and gene therapies (CGTs), diagnostic quality control partners face a critical challenge: adapting traditional methods to meet faster production timelines and the limited shelf life of cell therapy products while ensuring accuracy and reliability in results. The urgency of delivering these therapies to patients necessitates a reevaluation of existing quality control frameworks. Traditional methods that may have been sufficient for conventional pharmaceuticals often fall short when applied to the dynamic and sensitive nature of cell and gene therapies. This adaptation requires not only technological innovation but also a shift in mindset toward more agile and responsive quality control processes.

New therapies, new quality control processes

Cell and gene therapy manufacturers face significant quality control testing challenges due to the complex and highly variable nature of these therapies. One of the primary challenges is the need to develop novel testing methods that can accurately assess the unique attributes of these products. Unlike traditional pharmaceuticals, cell and gene therapies are living products, which means their characteristics can change over time and under different conditions. This variability necessitates the development of testing methods that can provide reliable and reproducible results despite these fluctuations.

Additionally, the limited number of viable sampling strategies poses a significant hurdle. Given the precious and often scarce nature of cell and gene therapy products, extensive sampling for quality control purposes is not always feasible. Manufacturers must therefore devise strategies that maximize the information obtained from minimal sample volumes, ensuring that enough product remains available for therapeutic use. Concerns over raw material consistency further complicate the quality control landscape. The biological nature of these therapies means that raw materials can vary significantly from batch to batch, potentially impacting the final product's quality and efficacy. Ensuring consistency in raw materials is crucial for maintaining the integrity of the therapy.

The potential for cross-contamination is another critical concern. The manufacturing processes for cell and gene therapies often involve handling multiple products simultaneously, increasing the risk of cross-contamination. Implementing stringent contamination control measures is essential to prevent this and ensure the safety and purity of the final product. Moreover, the need for rapid results to minimize patient wait times adds another layer of complexity. Patients awaiting cell and gene therapies often have urgent medical needs, making timely delivery of these treatments critical. Quality control processes must therefore be optimized to provide quick and accurate results without compromising on thoroughness.

All these challenges must be addressed while adhering to strict regulatory standards. Regulatory bodies have established rigorous guidelines to ensure the safety, efficacy, and quality of cell and gene therapies. Manufacturers must navigate these regulations carefully, ensuring that their quality control processes meet all necessary requirements.

Minimizing 'over-testing' to maximize product

An emerging consideration unique to cell and gene therapies is the need to develop a testing plan that minimizes over-testing, thereby maximizing the amount of sample, or product, available for patient use. This is particularly important given the often-limited availability of these highly specialized and valuable products. Strategic decisions in testing—such as choosing the right testing partner, streamlining upstream and downstream processes, and ensuring automation and accuracy—can facilitate a faster, more efficient path from lab to patient. By carefully selecting a testing partner with expertise in cell and gene therapies, companies can leverage specialized knowledge and advanced technologies to optimize their testing protocols.

Furthermore, because no two facilities or products are identical in the cell and gene therapy space, diagnostic partners are uniquely positioned to holistically analyze a customer’s development and manufacturing processes. They can provide tailored recommendations to enhance testing efficiency and develop new analytical methods. For instance, next-generation sequencing can be employed to accurately assess critical quality attributes such as cell viability, purity, potency, and genetic integrity. This level of precision is crucial for novel cell and gene therapy products where standard assays may not be suitable. Additionally, diagnostic partners can assist in the validation and implementation of these new methods, ensuring they meet regulatory requirements and industry standards.

Moreover, the dynamic nature of cell and gene therapy development necessitates a flexible and adaptive approach to testing. As new technologies and methodologies emerge, continuous collaboration with diagnostic partners can help companies stay at the forefront of innovation. These types of ongoing partnerships can lead to the discovery of more efficient testing strategies, ultimately reducing time-to-market and improving patient outcomes. By investing in robust testing frameworks and fostering strong relationships with diagnostic partners, companies can navigate the complexities of cell and gene therapy development more effectively.

Recently, bioMérieux has collaborated with various customers to develop customized testing plans that address the unique needs of individual facilities and products across multiple categories in relation to mycoplasma testing. This collaboration has been instrumental in ensuring that the testing protocols are tailored to the specific requirements of each facility, thereby enhancing the accuracy and reliability of the results.

During these conversations, several themes common to a collaborative approach have been regularly mentioned. They are as follows:

 When a sample has a higher cell density, testing an entire batch becomes impractical due to volume and resource constraints. High cell density can lead to challenges in sample handling and processing, making it difficult to obtain representative results from a single batch. The rapid advancement of cell and gene therapy has resulted in limited FDA guidance on the appropriate batch volume to test and whether the focus should be on the cells or the matrix. This lack of clear regulatory direction can create uncertainty for manufacturers, who must balance the need for thorough testing with the practical limitations of their processes. In such scenarios, an experienced partner can provide valuable guidance as new regulations are introduced. By leveraging their expertise and staying abreast of the latest regulatory developments, these partners can help manufacturers navigate the complexities of mycoplasma testing. They can offer insights into the most effective sampling strategies, ensuring that the testing is both comprehensive and efficient.

Selection of relevant species for validation.

 For mycoplasma detection method validation, testing every compendial species is unnecessary. Instead, using a representative selection of common and relevant species encountered in cell culture environments streamlines the process, making it more efficient and cost-effective. This targeted approach ensures that the validation process remains practical while maintaining adequate sensitivity and specificity across potential contaminants. By focusing on the most prevalent and relevant mycoplasma species, laboratories can optimize their resources and reduce the time and cost associated with extensive testing. This approach also allows for a more manageable and focused validation process, ensuring that the methods are robust and reliable for detecting the mycoplasma species most likely to be encountered in the specific cell culture environment.

The validation process should demonstrate sufficient coverage against likely mycoplasma species in the samples. This involves carefully selecting species that are representative of the broader mycoplasma population, ensuring that the detection methods can identify a wide range of potential contaminants. The goal is to achieve a balance between thoroughness and efficiency, providing confidence in the testing results without the need for exhaustive species-by species validation.

With the increasing use of molecular methods like polymerase chain reaction (PCR) for mycoplasma detection, the need to test against every species might be less critical. PCR assays can often detect a broad range of mycoplasma species based on conserved genetic sequences. These sequences are shared among different mycoplasma species, allowing for the detection of multiple species with a single assay. This capability significantly enhances the efficiency of the validation process, as it reduces the need for extensive species-specific testing. Moreover, the use of molecular methods like PCR offers additional advantages, such as increased sensitivity and faster turnaround times compared to traditional culture-based methods. These benefits are particularly important in the context of cell and gene therapies, where timely and accurate detection of contaminants is crucial for ensuring product safety and efficacy.

Analytical testing strategies for upstream and downstream processes. 

Rapid sterility and mycoplasma testing at the upstream stage of cell and gene therapy development significantly reduces the burden on the downstream process by allowing for early detection and mitigation of potential contamination sources. This early intervention is crucial as it helps to identify and address contamination issues before they can affect larger batches of product, thereby reducing product loss and delays. Implementing rapid testing methods upstream ensures that any contamination is detected at the earliest possible stage, allowing for immediate corrective actions. This proactive approach not only prevents the spread of contaminants but also minimizes the risk of compromising the entire production batch. By catching issues early, manufacturers can avoid the costly and time-consuming process of reworking or discarding contaminated products, leading to more efficient use of resources and reduced production costs.

Moreover, this strategy enhances workflow efficiency by streamlining the production process. With early detection and mitigation of contamination, the downstream process can proceed with greater confidence and fewer interruptions. This seamless transition from upstream to downstream stages ensures that the production timeline remains on track, ultimately speeding up time-to-market for cell and gene therapies.

Ensuring product integrity is another critical benefit of rapid upstream testing. By maintaining a contamination-free environment from the outset, manufacturers can uphold the highest standards of product quality and safety. This is particularly important in the field of cell and gene therapy, where the therapeutic products are often highly sensitive and complex. Maintaining their integrity throughout the production process is essential for their efficacy and safety when administered to patients. Rapid sterility and mycoplasma testing contribute to the high safety and quality standards of cell and gene therapy development by providing reliable and timely data on the contamination status of products. These data are essential for making informed decisions about the production process and ensuring that only the highest quality products reach the patients, a proactive approach that ultimately leads to better patient outcomes. By ensuring that cell and gene therapies are free from contamination and produced to the highest standards, manufacturers can deliver safe and effective treatments to patients. This not only improves the health and well-being of patients but also increases their trust in the therapies and the companies that produce them.

The future of cell and gene therapies involves more than just technological advancements; it’s about optimizing every step—from manufacturing to testing—to deliver life-saving treatments more efficiently and with the highest quality assurance. This holistic approach ensures that each phase of the therapy development process is fine-tuned to maximize efficacy, safety, and speed. By focusing on continuous improvement and innovation, the industry can overcome existing challenges and pave the way for groundbreaking treatments that can address previously untreatable conditions.

Partnering with an experienced testing partner in the cell and gene therapy space is crucial for navigating the complexities of quality control. These partners bring a wealth of knowledge and expertise, helping manufacturers implement robust testing protocols that are both relevant and efficient. They play a vital role in ensuring that tests are not only scientifically sound but also compliant with evolving regulatory requirements. This compliance is essential for gaining regulatory approval and ensuring that therapies meet the highest standards of safety and efficacy.

With scientifically grounded and best practice testing strategies, the industry is poised to scale rapidly. These strategies involve leveraging the latest advancements in testing technologies, such as high-throughput screening and advanced molecular diagnostics, to enhance the accuracy and speed of quality control processes. Moreover, the collaboration between manufacturers and testing partners enables the development of customized testing solutions that are tailored to the specific needs of each therapy and production facility. By addressing the unique challenges of cell and gene therapy production, these solutions ensure that quality control processes are both effective and efficient.

As the industry continues to evolve, the ability to bring more cell and gene therapies to market will have a transformative impact on patient care. These therapies have the potential to provide long-lasting and even curative treatments for a wide range of diseases, from genetic disorders to cancer. By optimizing every step of the development process and ensuring the highest standards of quality control, the industry can deliver these life-saving treatments to patients more quickly and reliably.

Ambili Menon, PhD, is senior manager, scientific affairs at bioMérieux.

®
Vol. 49, No. 7
September 2025
Pages: 26–29

When referring to this article, please cite it as Menon, A. Optimizing Testing in Cell and Gene Therapy. 

The advancement of cell and gene therapies (CGTs) necessitates a reevaluation of traditional quality control methods to accommodate faster production timelines and the unique characteristics of these therapies. Manufacturers face challenges such as developing novel testing methods, managing limited sampling strategies, ensuring raw material consistency, and preventing cross-contamination. Collaborations with diagnostic partners are crucial for optimizing testing protocols, leveraging advanced technologies, and ensuring regulatory compliance. By focusing on efficient quality control processes, the industry can enhance the speed and reliability of delivering life-saving CGTs to patients.

Analytics

The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods. Manufacturers and diagnostic partners must collaborate to create innovative, compliant testing strategies that preserve product integrity, meet tight timelines, and deliver life-saving treatments faster.

Optimizing Testing in Cell and Gene Therapy: A Key Driver for Industry Growth and Adoption

Patient adherence to medication is a challenge. Patients prefer the use of oral medicines over injectable ones for obvious reasons. Therefore, there is an ongoing need to develop personalized and patient-centric delivery solutions, including devices, for the administration of oral medicines that fit patient lifestyles and optimize the safe and effective use of oral medicines. Key attributes include improved taste and ease of swallowing, patient-friendly administration, flexible dosing, and reduced dosing frequencies.

More sophisticated and tailored solutions are emerging, including modified-, sustained-, extended, and controlled-release formulations; smart pills incorporating digital technologies for sensing and reporting; transdermal patches; and subcutaneous implants. New manufacturing methods are also being explored to enable more personalized and patient-centric dosage forms, such as 3D printing of oral solid dosage (OSD) drugs.

Personalized OSD forms aim to improve outcomes and adherence by tailoring medicines to each patient’s needs. “Standard tablets are easy to mass-produce but do not account for differences in age, weight, genetics, or disease progression,” says Bing Xun Tan, pharmaceutical application laboratory manager, Roquette Health & Pharma Solutions. “Customizing dose strength or form maximizes therapeutic efficacy while minimizing side effects, which is crucial for pediatric and geriatric patients,” he notes.

Personalized formulations support drug titration—such as loading and maintenance dosing—as well as body surface area- or weight-based adjustments, which are particularly important in oncology and pediatric care, according to Thierry Jomini, CEO and founder of AbbatiaLabs. In addition, he observes that personalized dosing facilitates safe medication tapering, giving patients a better chance to discontinue treatment optimally, and helps combat issues like antibiotic resistance and drug habituation. Finally, comments Jomini, solid oral forms offer superior stability compared to liquids, enabling global accessibility even in regions without refrigeration, thus ensuring reliable treatment delivery across diverse environments.

Advances like 3D printing, multiparticulate systems, and improved excipients such as pregelatinized starch or mannitol now enable bespoke formulations, according to Tan. Regulators, he adds, are also starting to play a role. FDA’s pediatric exclusivity provision (1), for instance, provides a financial incentive for pharmaceutical manufacturers to conduct and submit pediatric studies supporting the development of age-appropriate dosage forms that could also allow for dose titration. Similarly, in Europe, the Pediatric Use Marketing Authorization (PUMA) (2) incentivizes medicines developed exclusively for use in the pediatric population with data and market protection for product authorization.

“These drivers support the shift from ‘one-size-fits-all’ medicines towards precision approaches that make drug therapy safer, more effective, and better adapted to the patient,” Tan concludes.

Enhancing treatment efficacy through better adherence

The drivers for patient-centric formulation development are similar to those for personalized OSD drugs because both approaches focus on enhancing treatment efficacy and patient adherence by emphasizing individual preferences and needs, says Lydia Marinou, technical sales manager with Adragos Pharma.

As examples, Marinou points out that flexible dosing schedules and dosage forms that align with patients' lifestyles can significantly improve adherence rates, and the use of mobile health applications that gather patient feedback further supports this trajectory. “Successful case studies, such as patient-centric inhalers collecting real-time data, illustrate how understanding patient profiles and medication adherence can lead to more effective and satisfactory treatment outcomes,” she adds.

John van den Anker, chief scientific officer of AbbatiaLabs, agrees that the primary motivation for both personalized and patient-centric products is improved adherence to therapy. “Medications that are easier to administer—whether by patients themselves or by caregivers—significantly increase the likelihood of consistent treatment,” he notes. “Moreover,” he continues, “patient-centric products help reduce dosing errors, which are a leading cause of medication-related issues, particularly in settings requiring precise, bodyweight-based dosing such as pediatric care.”

Patient-centric design, according to Tan, focuses on making medicines easier to use—like easier-to-swallow tablets or chewables, taste-masked forms for children or older adults, or fast-melt options including orally disintegrating tablets (ODTs) for those with dysphagia. “By reducing behavioral and sensory barriers, these designs encourage correct use. Commercially, they appeal to patients, caregivers, and providers seeking better compliance,” he says.

In addition, Tan comments that as lifestyle medicines (like those for weight loss) grow in popularity, there is also a market-driven demand for more lifestyle-friendly, personalized formats. This trend, he observes, mirrors similar trends in nutraceuticals and cosmetics, where personalization is already a significant consumer demand.

Significant overlap between personalized and patient-centric OSD drugs

Consequently, there is a clear overlap between personalized and patient-centric oral solid dosage drugs, as both concepts prioritize ease of use and accuracy in drug administration, according to Jomini.

Tan, meanwhile, views personalized OSD drugs with doses and/or drug combinations customized for individuals as, effectively, a subset of the broader patient-centric approach. “While personalization focuses on pharmacological customization (right drug, right dose), patient-centric design ensures that the dosage form itself is acceptable, convenient, and adapted to the patient’s needs and preferences,” he explains. In practice, Tan notes that advances like 3D printing enable both at once: for example, a chewable, flavored tablet designed for a child that also delivers a precise weight-based dose.

The development of personalized and patient-centric oral solid dosage (OSD) drugs aims to improve medication adherence and therapeutic outcomes by tailoring treatments to individual patient needs. Innovations such as 3D printing, smart pills, and flexible dosing devices are transforming drug delivery, making it more precise and user-friendly. However, challenges in manufacturing, scalability, and regulatory compliance persist. Regulatory frameworks are evolving to accommodate these innovations, emphasizing patient-focused approaches. Future advancements may include AI-driven formulation design and real-time monitoring systems, further enhancing personalized medicine.

New manufacturing methods are being explored, but challenges are still present in personalized medicine development.

Pharmaceutical Technology September 2025