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.

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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. 

Articles

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

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.

Van den Anker contends that flexible dosing devices—such as POWDOSE from AbbatiaLabs—exemplify this convergence by enabling patients or caregivers to easily and reliably select the precise dose needed, typically in just a couple of simple steps. “These innovations support both individualized treatment regimens and user-friendly administration, making them essential tools for delivering truly tailored and accessible therapies,” van den Anker believes.

Overall, concludes Tan, “patient-centric design provides the usability framework, while personalization ensures pharmacological precision. Together, they represent a shift from viewing the patient as a passive recipient of standardized treatment to an active participant whose unique needs and circumstances shape the final product.”

Recent technology advances of note for van den Anker include flexible and user-friendly dosing solutions that allow precise, individualized dosing. He also highlights 3D printing as an emerging and powerful tool for creating customized drug formulations tailored to each patient’s needs; long-acting formulations, which contribute by reducing dosing frequency and improving adherence; and easy-to-swallow formats—such as multiparticulates and dissolvable tablets—that enhance patient comfort and usability, particularly for children and the elderly. “Together, these innovations are transforming the landscape of oral drug delivery toward more tailored and accessible care,” he states.

Manufacturing, scalability, and regulatory complexity challenges

Developing patient-centric and personalized OSD drugs is not a simple endeavor, however. There are several challenges along the way. The biggest hurdles, according to Tan, lie in manufacturing, scalability, and regulatory complexity.

One major barrier highlighted by Jomini is the need for the pharmaceutical industry to invest in new infrastructure, such as equipment for 3D printing individualized doses or systems for filling flexible dosing devices, which also require compatible multiparticulate formulations.

Technologies like 3D printing, adds Tan, are well suited to one-off or small-batch production, but because each tablet is printed layer-by-layer, this method is too slow and costly for large-scale deployment. In addition, he notes that supply chains must also adapt, particularly for excipients. “The sourcing of ready-to-use blends and functional excipients that streamline small-batch production has never been more important,” Tan states.

Furthermore, Tan emphasizes that highly individualized production demands new distribution models, specialized training, and flexible quality systems capable of ensuring consistency and safety for varied products. Regulations need updating as well. “Regulatory frameworks, while evolving, still generally assume mass production of standardized forms. Clear guidance on quality controls, validation, and data protection (especially when handling patient-specific data) is still developing,” Tan says.

Another challenge for van den Anker is the need for development of robust clinical evidence clearly demonstrating that precise dosing leads to better health outcomes. In addition, he observes that for many personalized and patient-centric OSD drugs, “payers must be willing to support potentially higher costs for these advanced therapies in recognition of their benefits in adherence and therapeutic effectiveness.”

Overall, according to Tan, “the crux is how to scale up personalization without compromising cost-effectiveness, safety, or regulatory compliance—challenges that will require not only technological solutions but also reimagined business and regulatory models.”

Regulatory considerations significantly impact the development of personalized and patient-centric OSD drugs, and agencies are adapting their frameworks to better accommodate innovations, Marinou says. She points to incorporation of quality-by-design principles to ensure safety and efficacy as an example.

Regulatory frameworks must continue to evolve, however, to address novel challenges while maintaining safety and quality, according to Tan. “New production methods require robust validation (especially for on-demand and small-scale manufacturing environments), as well as solid quality controls and assured compliance with good manufacturing practices. Handling patient-specific data also demands stringent privacy protections,” he explains.

The approval of patient-customized 3D-printed medicines and devices exemplifies the evolving landscape for Marinou (3–5). She emphasizes, though, that addressing compliance complexities and establishing robust pharmacovigilance systems remain critical for companies aiming to introduce personalized treatments that align with regulatory standards. “Navigating the complexities of compliance is essential,” she says, “particularly as the inclusion of real-world evidence, which allows companies to leverage patient data for adaptive regulatory pathways, becomes increasingly important.”

If delivery is achieved using specialized devices, there are additional regulatory considerations. Products that include a device component—such as a flexible dosing system—may be classified as combination products, which can introduce added regulatory complexity, especially for developers more accustomed to small-molecule drugs, says Jomini. “While this pathway is more common in biologics and injectables, it poses a challenge in the OSD space. Moreover, any medical claims, such as improved outcomes, must be substantiated by robust clinical evidence,” he observes. Despite these hurdles, Jomini does note that specialized regulatory expertise is available to support developers through this process.

Also on the positive side, Tan notes that many pharmaceutical regulatory agencies are already encouraging patient-focused approaches. In addition to the aforementioned pediatric development incentives, he highlights FDA’s Patient-Focused Drug Development initiative (6), which emphasizes incorporating patient perspectives and needs. “Together, these regulatory drivers support safer, more tailored therapies that meet the multifaceted needs of a diverse, global patient body,” Tan says.

Despite the many challenges, developers of OSD drugs are pursuing innovative solutions that support the creation of personalized and patient-centric products designed to increase medication adherence and provide better outcomes.

Tan notes that the ability of 3D printing to enable on-demand, patient-specific tablets with tailored doses and flavors has been demonstrated for pediatric use in hospital trials (7). “Hospital pharmacies are beginning to adopt 3D printers and precise dosing devices to create tailored oral forms at the point of care—such as child-friendly, flavored tablets with exact doses,” he notes.

Fast-melt tablets and dissolvable oral films improve administration for those with swallowing difficulties, while multiparticulate systems, such as pellets and minitablets, enable flexible drug-dose combinations that can reduce pill burden, according to Tan. He points to the OraFID (Sensidose, part of Navamedic ASA) prefilled dose dispenser as simplifying minitablet administration by allowing patients and caregivers to accurately dispense the required dose. “Minitablets and multiparticulates promise superior accuracy and dosing flexibility, allowing complex regimens to be delivered in single capsules or even sprinkles with specific release profiles,” he says.

Other advances highlighted by Tan include improvements to excipient offerings such as plant-based mannitol and other starch derivatives, which ultimately support better taste-masking, compressibility, and customized release profiles. “The industry’s growing understanding of the importance of these factors is driving the development of excipients designed specifically for patient-centric forms and advanced manufacturing, laying the groundwork for truly personalized, user-friendly oral medicines,” he says.

Innovative drug delivery systems, meanwhile, are transforming personalized medicine, according to Marinou. “Nanoscale carriers, such as dendrimers and liposomes, enhance drug solubility and targeting, allowing for treatments such as personalized cancer therapies that deliver chemotherapeutics directly to tumor cells. Layered tablets provide controlled release of multiple drugs, which is particularly useful for the management of chronic conditions, as seen in combination therapies for diabetes. Additionally, smart delivery systems, such as implantable devices that can adjust dosages based on real-time physiological data, represent the future of medication adherence and effectiveness, allowing for tailored treatments that adapt to individual patient dynamics,” she comments.

In the near future, van den Anker believes the development of oral formulations for traditionally injectable therapies, such as oral insulins and GLP-1 drugs for obesity and type 2 diabetes, will have significant potential to advance personalized and patient-centric OSD drugs. “These innovations could greatly improve patient comfort and adherence,” he states.

Longer-term, Tan believes artificial intelligence (AI)-driven formulation design and fully decentralized manufacturing will revolutionize production of personalized and patient-centric OSD drugs. “AI models can help predict optimal doses and formulations based on individual patient data, while advanced manufacturing units in pharmacies or clinics produce these custom forms on demand,” he observes. Tan also expects smart ingestible devices and biosensors will eventually provide the added benefit of real-time monitoring and responsive drug release, enabling dynamic personalization (8). “Once the lingering technological and regulatory barriers have been addressed, these developments could create an interconnected, on-demand systems delivering personalized oral therapies at scale within the next decade.”

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EMA. Paediatric-use Marketing Authorisations. Ema.europa.eu. Updated July 31, 2025. 

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/paediatric-medicines-marketing-authorisation/paediatric-use-marketing-authorisations

Alqahtani; et al. 3D Printed Pharmaceutical Systems for Personalized Treatment in Metabolic Syndrome. 

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Triastek. Triastek's 3D-Printed Gastric Retention Product T20G Receives FDA IND Clearance. Press Release. March 17, 2025. 

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https://www.fda.gov/drugs/development-approval-process-drugs/cder-patient-focused-drug-development

Stoops; et al., Clinical Implementation of a Paediatric 3D-printed Combination of Sulfamethoxazole and Trimethoprim. 

Chai; et al., Utilizing an Ingestible Biosensor to Assess Real-Time Medication Adherence. 

 Dec;11(4):439-44. DOI: 10.1007/s13181-015-0494-8

Cynthia A. Challener, PhD is a contributing editor to

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

Keys to Navigating the Complex Drug Supply Chain

Focusing on the Fundamentals of Formulation

Effectively Using Contamination Control Strategies

Personalized and Patient-Centric Administration of Oral Medicines