Major Big Pharma Moves, Pressures of Capital Markets at Intersection with Autologous Versus Allogeneic

Behind the Headlines Episode 25

Questions about Real-World Evidence and Supply Chain Security

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

The 100% tariff on imported drugs will pressure pharma companies to build manufacturing sites in the US or face significant costs.

How 100% Pharmaceutical Tariffs Will Impact Domestic Manufacturing and Supply Chains

Responses to the FDA draft guidance "Considerations for Complying with 21 CFR 211.110"

Stakeholders React to FDA's Push for Quality, Integrity, and Uniformity

Jennifer Markarian is a contributing editor for 

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Digital technologies are evolving rapidly and offer benefits for bio/pharmaceutical manufacturers and developers who seek digital transformation. New artificial intelligence (AI) and machine learning (ML) tools help manage, transform, and analyze data—including data coming from process analytical technology (PAT) tools—so it can be better used to develop process insights or for process control. Early adopters of these technologies have been process development laboratories, but implementation in commercial manufacturing is emerging.

“Historically, PAT has been used to define processes and build control strategies, but its integration into manufacturing has often been limited,” says Michalle Adkins, director of life sciences strategy at Emerson. She points to the emergence of inline spectral PAT, which makes it easier to embed spectral waveform data directly into control systems, as a significant advance.

“We’re also starting to see OEMs [original equipment manufacturers] including PAT in their offerings with their bioreactors, which signals a broader readiness to integrate advanced analytics not only in process development but also in commercial manufacturing,” Adkins says. “These initial steps are building the foundations to lead to these technologies rolling out to bigger scale solutions in the future.”

Currently, AI-based tools are often used to create process insights that people on operations teams can use to improve processes, but eventually AI tools will allow more automated control, suggests Ryan Thompson, senior specialist, Industry 4.0 at CRB.

“Huge strides are being made in bioreactor productivity (e.g., higher titers) and chromatography efficiency using these tools,” Thompson says. “The next big step will be [to take] the person out of the middle and have truly AI-based closed-loop control.”

The convergence of AI and ML with advanced process control is helping to address some particularly difficult measurement and control areas, adds Adkins.

“Additionally, regulatory bodies are increasingly open to and encouraging the use of these more automated approaches, particularly as companies are demonstrating success in both process development and targeted projects,” Adkins says. “With early successes demonstrated in bulk drug substance processes such as fermentation and purification, along with pilot-scale manufacturing, broader adoption is expected across the manufacturing lifecycle.”

Challenges and solutions for commercial manufacturing

A recent initiative by the BioPhorum IT Digital and Data collaboration tackled the need to need to improve collaboration and transparency between sponsors and contract manufacturing organizations (CMOs) in the area of deviation management.

“Historically, deviation management has been largely manual and fragmented, leading to inefficiencies, delays, and miscommunication,” says Ciera Clayton, Global Change Facilitator at BioPhorum. “Many companies still operate in the ‘predigital’ stages—where deviation information is exchanged manually, often via email, spreadsheets, or paper-based systems. These methods are prone to delays, errors, and lack of traceability. BioPhorum members recognized that digitizing this process could significantly enhance data integrity, accelerate issue resolution, and foster a more proactive quality culture across organizational boundaries.”

The BioPhorum IT Digital and Data, Digital Integration of Sponsor and Contract Organizations (DISCO) team published a paper in July 2025 to share its vision for digital deviation management (1). The group found that gaps between digital maturity of CMOs and sponsors caused difficulty in data exchange and decision-making.

“We have also learned that interoperability and shared digital standards are key to bridging these gaps,” says Clayton. “Even when one partner is more advanced, establishing common data formats, governance models, and secure exchange protocols can enable meaningful collaboration. Trust and transparenc are key; when partners align on expectations and invest in interoperability, they can overcome maturity mismatches and unlock significant value.”

Next steps from the DISCO team members aim to translate their vision into practical and scalable solutions, Clayton says. For example, one task is to develop standard data structures and integration specifications, with a focus on interoperability, good practice compliance, and scalability across multiple products and sites.

Work by other teams in the BioPhorum IT Digital and Data group will also inform the deviation management project. For example, the AI Validation team is publishing guidance to define frameworks for implementing AI in regulated environments, which will ensure that digital deviation data and other manufacturing insights can be leveraged responsibly, Clayton explains.

Digital Deviations: Improving Sponsor-CMO Collaboration

Moving from process development to commercial manufacturing requires technology to be robust and designed for use by operators on the factory floor.

“If new technologies add uncertainty or additional steps, they’re unlikely to be widely adopted,” notes Adkins. “Historically, that has been a challenge, but we’re starting to get over those complications as the technologies themselves mature. Today’s solutions are far more robust and designed for high-performance environments.”

Technology transfer is another concern. “Teams need to be sure that when they change the scale, it won’t change the outcomes,” Adkins says. “They need collaborative software solutions designed specifically to help navigate scale-up and scale-out.”

Data handling is also a crucial issue. “Process data on the factory floor is generally unstructured and lacks context,” says Thompson. “It takes a lot of time and effort to search, organize, and clean data before [they are] useful for AI/ML algorithms.”

Large quantities of data are needed, however, because AI/ML accuracy and insights improve with the quantity of data.

“Data modeling is a necessary first step to meaningful AI/ML, where process data and modern architectures, such as a unified namespace, should be considered,” Thompson suggests.

“One of the most critical—and often underestimated—elements of effective data analytics in pharma manufacturing is context,” agrees Adkins. “Teams must be empowered to generate and preserve context as data flows across the enterprise. Whenever context needs to be reconstructed, the value of that data diminishes. It becomes harder to use, more expensive to manage, and slower for driving meaningful action. That’s not just a technical challenge—it’s a strategic one.”

Emerson’s new digital platform will enable integration of disparate industrial automation technologies, according to Adkins. A centralized data model will allow teams to collect full context and share the master data across solutions without needing redundant definitions in separate systems (e.g., the distributed control system, the manufacturing execution system, and others), Adkins says.

“The enterprise operations platform will eliminate that fragmentation by creating a common data platform that distributes consistent equipment information across all solutions via a shared data fabric,” Adkins says. “This not only simplifies data management but also strengthens the foundation for more autonomous and scalable operations.”

Using the approach of managing data as a product, the platform is designed to make data findable, accessible, interoperable, and reusable (i.e., the FAIR principles).

“This approach enables scalable, AI-ready data environments that support both operational efficiency and innovation,” says Adkins.

Digital twins are tools that have found success in process development and promise additional benefits in manufacturing control strategies. The integration of PAT data with a digital twin of a process offers multiple benefits, says Andrew Whytock, head of Digitalization for Pharma at Siemens, which supplies digital tools including digital twins and the Simatic Sipat software platform for implementing PAT in pharmaceutical development and manufacturing.

“Integrating PAT enables right-first-time production, as real-time data and predictive models minimize errors and ensure quality from the very beginning,” Whytock explains. “This integration also leads to improved yields, with continuous feedback and optimization enhancing output.”

Whytock says that a digital process twin can minimize physical experimentation and significantly reduce development time through virtual testing and optimization in the digital twin. Although these tools can allow significant efficiency gains and faster time-to-market, a potential hurdle is the initial investment cost for infrastructure, software, and integration of disparate processes into a unified, data-driven approach.

In addition, says Whytock, “Overcoming the reliance on extensive physical experimentation, a long-standing practice in biopharma development, demands a paradigm shift in how processes are designed, tested, and scaled up. This transition also necessitates specialized expertise in data science, modeling, and automation, which may not be readily available internally, requiring significant training or external consultancy.”

Digital twins can be used for batch processes and are fundamental for continuous processes, for which process automation is crucial, suggests Whytock. Continuous manufacturing saves space, reduces costs, and speeds up the path from lab to patient, he says, but the shift from batch to continuous still faces resistance due to perceived risks and question marks about return on investment.

“Ultimately, the challenge lies in navigating the complexities of digital transformation while ensuring compliance, maintaining product quality, and realizing the full efficiency gains offered by these cutting-edge solutions,” he explains.

Although AI tools and digital twins may be used in various ways to improve quality and potentially enable closed-loop control and real-time release, process understanding remains crucial. In a 2024 survey of pharmaceutical and biotechnology companies, CRB found that intelligent devices and smart data (e.g., PAT) are indeed already being used by more than half of respondents for real-time batch analysis (i.e., process understanding) and by 40% of respondents for real-time batch release (1). A smaller segment (24%) reported using in-line or online sensor technology for real-time batch correction.

“Process understanding is a key component of being able to leverage AI into batch analysis, release, and correction,” cautions Thompson. “Relying on AI without a detailed process understanding will lead to implementations that cannot be validated—and of course, the rigor required increases as companies move from analysis, to release, to correction.”

A July 2025 publication from the International Society for Pharmaceutical Engineering (ISPE) GAMP Community of Practice, Software Automation and Artificial Intelligence Special Interest Group offers best practices for approaching AI projects integrated with current regulatory guidance (GAMP was formerly known as the acronym for good automated manufacturing practice) (2). The guide covers a broad range of use cases, including use of AI in data analysis for applications such as real-time release.

“An innovative approach combining PAT and AI models alongside robust control strategies can enable faster and more reliable product disposition by analyzing critical quality attributes in real-time rather than relying solely on end-product testing,” says Brandi Stockton, founder and managing partner of the Triality Group and lead of the ISPE GAMP AI Guide initiative.

“AI has the potential to enhance PAT by capabilities to identify subtle patterns in large amounts of data and support predictive control strategies by dynamic optimization of parameters to reduce process variability,” adds Martin Heitmann, consultant at the Triality Group and co-lead of the ISPE GAMP AI Guide initiative. “In process development, AI may reveal relationships between variables that traditional methods may miss, accelerating scale-up and tech transfer. Several key challenges to consider include data availability and quality, explainability and integration with existing control systems.”

The pharmaceutical industry has a reputation for being slow to change, but the fast pace of AI development may be altering that paradigm. Thompson says that AI has become a strategic necessity in the drug discovery and information technology functions of pharma companies. Although adoption of AI has been slower in the manufacturing side, Thompson predicts rapid adoption will occur as service providers start demonstrating successful implementations and manufacturers see the benefits.

“In the past three to five years, I have seen real changes [from] pharma being an insular industry to one seeking ideas from other sectors,” suggests Thompson. “AI is absolutely being adopted rapidly in pharma, and companies are creating new organizational units to invest in and [obtain] value from AI. It is slower to be adopted directly on the factory floor, but pharma companies are embracing AI more than most other manufacturing sectors, as they have much more to gain than typical companies.”

2. Stockton, B.; Heitmann, M.; Staib, E.; et al. 

Articles

Digital technologies, particularly AI and ML, are transforming bio/pharmaceutical manufacturing by enhancing data management and process control. Early adoption has been seen in process development, with commercial manufacturing beginning to integrate these technologies. AI tools are improving bioreactor productivity and chromatography efficiency, with potential for fully automated control. Challenges include technology robustness, data handling, and technology transfer. Digital twins and PAT integration offer benefits in process control and efficiency. The pharmaceutical industry is gradually embracing AI, with significant potential for innovation and efficiency gains.

Advances in digital technologies offer effective data handling for bio/pharma manufacturing.

Optimizing Data Use for Digital Transformation

 is vice-president, Product Management for AI & Data at 

, based in London. A data science actuary, he has built his career in fintech and health-tech, and specializes in AI-powered, data-driven, yet human-centric product innovation. He previously led an AstraZeneca digital incubator and today remains on the board of a health charity, Scleroderma & Raynaud's UK (SRUK), which is dedicated to improving the lives of people affected by those conditions in the UK.

Ai Agent, intelligence artificial development concept for Automation System. Developer uses a laptop for Ai Training and machine learning dashboard. Technology smart robot and agentic workflows | Image Credit: © Deemerwha studio - stock.adobe.com

Agentic artificial intelligence (AI)—the autonomous coordination of goal-driven AI “agents”—is arguably the most significant shift in AI since the advent of ChatGPT, because of the potential to redefine the way that organizations operate. Its autonomy lies in the ability of AI agents and their orchestrators (or “super-agents”) to reason, synthesize knowledge, and adaptively determine and coordinate the tasks and interactions needed to achieve a goal.

The ability to reason, anticipate, generate insight and knowledge, and make better decisions is perfectly matched to life sciences, an industry which is data-rich, process-heavy, and outcome-critical. As the pharmaceutical industry’s fascination with agentic AI grows, this three-part series explores the technology’s potential in pharma R&D, beginning with a summation of AI’s evolution up to now.

As the global pharma industry adapts to advances in science, evolving regulatory demands, and pressures on price and margins, AI has gained traction both as a practical solution to processing soaring workloads and as a means of transforming the work that companies do. Today, the technology is being deployed with increasing momentum, as well as rising ambition, as AI continues to progress and as organizations come to understand its full potential.

Generative AI (GenAI), which came to mainstream attention with the launch of ChatGPT in 2022, has proved a disruptive catalyst for whole industries, offering the ability to take what has gone before, amalgamate knowledge, distill key facts including fresh insights, and present these in new ways. In life sciences R&D, across functions including regulatory affairs and drug safety/pharmacovigilance, AI has paved the way for intelligent automation of highly labor-intensive routine processes. The technology is being actively used in marketing authorization application preparation, product change control/regulatory impact assessment management, adverse event case processing, and safety reporting.

From incremental process improvements to autonomous process reworking

Through these proliferating applications, AI has contributed to tangible improvements in process cost-efficiency. Gains have included accelerated task execution, honed accuracy and consistency in process output, and large-scale resource optimization, as teams of professionals have clawed back time for more strategic and challenging tasks. In deploying AI across these discrete use cases, pharma organizations and their function leads have learned a lot about the technology’s potential and how best to leverage it to get good and trusted results.

All of this has paved the way for an even bigger wave of AI advancement, in the form of agentic AI. This represents the move from the automation of existing or pre-defined processes to much greater autonomy over what AI does and how. Instead of single AI applications managing a process, agentic AI is more collaborative, multiplying the efficiency gains. It involves the autonomous contributions of a series of specialist AI agents to fulfill an assigned goal via the most effective means possible. These agents are coordinated by an AI “super-agent.” Given a goal, this AI orchestrator and its charges each deploy their respective intelligence, experience, and reasoning to fulfill their contribution to the wider goal in the most effective and efficient way they can. Combining all of this autonomous decision-making enables step changes in delivery through in-flight process adaptation.

Agentic AI is not just about doing things more efficiently and more accurately, as with previous incarnations of AI. Reaching beyond the scope of individual tasks, it offers potential for extended process reinvention.

Agentic AI is disruptive to the point that Microsoft’s CEO has suggested it will upend cloud software delivery models (1). The reason for this is that AI has the potential to diminish the centrality of the user interface by autonomously invoking multiple applications or tools to complete a broader task. This doesn’t just have implications for the way companies procure and use software; it also challenges afresh the traditional boundaries companies have between functional teams and between their respective data sets.

Agentic AI demands more so it can deliver more

All of the above has renewed emphasis on the quality and richness of companies’ underlying data assets, and how well these can be combined and leveraged by different agents in different contexts. It also raises expectations around how confidently AI-based reasoning and distilled insights can be trusted.

It is here that the potential for agentic AI collides with the need for robust system and data interoperability, clearly defined parameters (multi-agent operating frameworks), and strong governance—that’s if agentic AI is to be validated and relied upon for use in a regulated, patient-oriented context.

Ideally, a balance should be struck between empowering agentic AI with all of the knowledge, detail, and logic it needs to add value above and beyond what humans can achieve, while containing the technology’s leeway (so that it doesn’t overstep or go rogue), a concept known as “bounded autonomy”.

This last provision, which will be explored in more detail in the third article of this series, is critical. GenAI’s detractors have long been concerned about the various platforms’ propensity to “hallucinate” to fill gaps in their knowledge when providing an answer or summary (although, this is being addressed rapidly) (2). Without transparency enabling users to check the authenticity of sources or the veracity of findings, no company would be able to trust the output of GenAI tools, especially in a strictly regulated environment.

In an agentic AI context, where systems are afforded new autonomy across extended workflows, the stakes for governance rise sharply. The risks go well beyond incorrect outputs; they include unintended data movement, loss of operational control, misaligned decision-making, and blurred lines of accountability. Managing these demands a shift from static safeguards to dynamic oversight: governance that can adapt as agents interact, roles evolve, and contexts change. This will be explored in depth in the final part of the series, but the core point is clear—without a robust, adaptive governance framework, the very autonomy that makes agentic AI powerful can also amplify risk.

In summary, the arrival of agentic AI introduces both significant potential for operational reinvention and the need for advanced systems and frameworks to facilitate positive transformation while mitigating risk.

The next article in this three-part series will consider the big-picture potential for agentic AI in pharma R&D functions, and describe some initial use cases now being piloted. Part Three will then draw out the critical success factors involved to unlock the technology’s full potential.

Satya Nadella | BG2 w/ Bill Gurley & Brad Gerstner.

, Dec. 12, 2024 (accessed Aug. 15, 2025).
2. Google Cloud. 

Agentic AI represents a transformative shift in AI, enabling autonomous coordination of goal-driven AI agents, which could redefine organizational operations. This technology is particularly suited to the life sciences sector, offering potential for process reinvention beyond mere efficiency improvements. The pharmaceutical industry is increasingly adopting agentic AI to enhance R&D processes. However, its implementation demands robust data interoperability, governance, and bounded autonomy to ensure reliability and mitigate risks. The series will further explore agentic AI's potential in pharma R&D and the critical success factors for its effective deployment.

In a three-part series, the author explores the potential use of agentic AI in pharmaceutical R&D.

What’s Reasonable to Expect from Agentic AI in Pharma? Part One: The Evolution of AI

Converging Fronts of Cancer Treatments

In this PharmTech video feature, we take a look at a few of the latest news stories about advancements and research in the oncology field.

Cancer research and treatment center planned for London

In May 2025, Aviva Capital Partners and mixed-use developer Socius announced plans for a new £1 billion (US$1.33 billion) investment to create a cancer research and treatment center in Sutton, London, with approximately 1 million square feet of state-of-the-art research and laboratory space where life sciences companies can come together with academic researchers and clinicians to push cancer research forward.

https://www.pharmtech.com/view/cancer-research-and-treatment-center-planned-for-london

Emerging modalities for cancer treatment have been advancing. Cell and gene therapies, peptides, monoclonal antibodies, antibody drug conjugates, tumor-infiltrating lymphocytes (TILs), and vaccines such as messenger RNA, as well as a variety of other treatments have developed in recent years. While Chimeric antigen receptor (CAR T)-cells have been a focus for the industry, TILs are focused on treating solid tumors, according to Jason Bock, co-founder and CEO of CTMC. 

"TILs have been around for decades, especially in academic centers, and have a slightly different approach, where we take a piece of the tumor and extract the cells, the immune cells that [have] already found their way into the tumor and are presumably fighting that tumor, and then we can have methods to expand, in some ways, rejuvenate those cells to large numbers and then reinfuse those to the same patient,” says Bock. “Another really exciting aspect about TILs is that they have inherent specificity for the tumor that allows us the opportunity to further genetically engineer them for improved fitness, persistence, or durability.”

https://www.biopharminternational.com/view/emerging-treatments-for-cancer

In other news, CellCentric, a Cambridge, UK-based clinical-stage biotechnology company, is developing as a potential first-in-class oral treatment, inobrodib, for several specific types of cancer, notably multiple myeloma. The company received $120 million in Series C funding to support a Phase II/III study in May 2025.

https://www.pharmtech.com/view/cellcentric-completes-120-million-series-c-funding-round-for-multiple-myeloma-treatment-inobrodib

Medicines Discovery Catapult (MDC), a national life sciences service dedicated to drug discovery, and Crown Bioscience, a contract research organization, announced in September 2025 that they are collaborating on an integrated translational biology platform to be used to develop radiopharmaceuticals. The collaboration will support the advancement of radiopharmaceuticals, including new isotopes and optimizing targeting agents, and will enable testing of how radiopharmaceuticals perform in the body.

https://www.pharmtech.com/view/medicines-discovery-catapult-and-crown-bioscience-create-alliance-for-radiopharmaceuticals

In August 2025, FDA published a draft guidance document titled 

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development

 that was created to assist drug sponsors with identifying an optimized dosage for radiopharmaceutical therapies (for oncology indications during clinical development. The guidance addresses clinical development before submitting a marketing application for a new indication and usage.

https://www.pharmtech.com/view/fda-releases-guidance-on-oncology-therapeutic-radiopharmaceuticals

Videos

Advancements for novel cancer therapies are booming. This video takes a look at some of the latest efforts in the cancer research and therapy arena.

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

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The European Medicines Agency (EMA) released a statement (1) on Sept. 22, 2025 regarding the European Commission’s (EC) publication of its new 

 that define rules for modifying and updating drug marketing authorizations (2, 3). The guidelines are expected to streamline lifecycle management, provide flexibility, and adapt to technical advancements.

“Marketing authorization holders are responsible for ensuring that the medicine remains compliant throughout its lifecycle and are obliged to report any changes—‘variations’—to the initial authorization, as they arise,” the EC stated in a press release (2). “These variations must be assessed by the authorities based on their impact on public health and the medicine's characteristics.”

The new guidelines were developed with support from EMA and the European medicines regulatory network and are part of efforts to improve the efficiency of the regulatory framework in the European Union. There have been an increasing amount of variation submissions resulting from scientific and technological advances in drug development, according to EMA. These guidelines are partially in response to this increase in variation submissions.

The new EC guidelines provide information on variation classifications, extensions, updates on vaccines, safety restrictions, and pediatric considerations. It also provides guidance on work sharing, including submission of variation applications and work sharing assessments. An annex gives details of the classifications of variations and on the scientific data submitted for variations and how these data should be documented.

The annex also provides a list of changes that are considered extensions. “Under Article 19 of the Variations Regulation, such applications are evaluated in accordance with the same procedure for granting the initial marketing authorization to which they refer,” the EC guidelines state. “The extension may either be granted as a new marketing authorization or included in the initial marketing authorization to which it refers. Extension applications must be submitted by the holder simultaneously to all relevant authorities.”

According to EMA, variations are classified Type IA, Type IB, or Type II using a risk-based approach. Type IA variations are minor changes with little impact, such as a change of company address. Type IB changes are minor but require notification, such as safety updates. Type II are major changes like a new indication for the drug.

The EC guidelines will be required for variation applications submitted to EMA started on Jan. 15, 2026. EMA will published new procedures that include the guidelines in December 2025; the new procedures will outline regulatory and procedural information on managing variations under the new classification system and how to use regulatory tools (e.g., post-approval change management protocol and product lifecycle management document).

EMA. New Variations Guidelines to Streamline Lifecycle Management of Medicines. Press Release. Sept. 22, 2025. 

https://www.ema.europa.eu/en/news/new-variations-guidelines-streamline-lifecycle-management-medicines

EC. Commission Publishes New Measures for the Better Lifecycle Management of Medicine Authorizations. Press Release. Sept. 22, 2025. 

https://ec.europa.eu/newsroom/sante/newsletter-archives/67084

EU. Communication from the Commission–Guidelines on the Details of the Various Categories of Variation, on the Operation of the Procedures Laid Down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 Concerning the Examination of Variations to the Terms of Marketing Authorisations for Medicinal Products for Human uUe, and on the Documentation to be Submitted Pursuant to those P rocedures. EUR-Lex. Sept 22, 2025. 

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C_202505045

The European Medicines Agency (EMA) and the European Commission (EC) have introduced new Variations Guidelines to enhance the management of drug marketing authorizations. These guidelines aim to streamline lifecycle management, accommodate scientific and technological advancements, and ensure compliance throughout a drug's lifecycle. They classify variations into three types based on risk: Type IA (minor changes), Type IB (minor but requiring notification), and Type II (major changes). The guidelines, effective January 15, 2026, will provide detailed procedures for managing variations and utilizing regulatory tools.

EMA states the new variations guidelines will streamline lifecycle management and make processing variations quicker.

European Commission Streamlines Drug Lifecyle Management

 is an expert pharmaceutical consultant based in Bengaluru, India.

Close-up on micro plastic particles. The concept for water pollution and global warming. Macro shot on a bunch of microplastics that cannot be recycled. | Image Credit: © SIV Stock Studio - stock.adobe.com

The global ecosystem will always be a primary concern to humans, but with a new industrial revolution currently at its boom, the bio/pharmaceutical industry must be mindful of that revolution’s repercussions. Microplastics, a byproduct of plastics commonly used in packaging, could be vectors for organic contaminants.

When it comes to pharma, these organic contaminants may be considered drugs with intended, efficacious effects as well as unintended and toxic ones. Depending upon levels of drugs that remain in used and/or discarded packages, these organic contaminants can enter the ecosystem and have damaging effects. So, there is a need to be sensitized to this topic, and for the industry to do its part to remedy it.

The advent of plastics has revolutionized the pharmaceutical packaging industry. Whether it is solutions, suspensions, powders, granules, tablets, and capsules in bottles, or ointments, creams, gels, and pastes in tubes, or injectable solutions in infusion bags and syringes, plastics are ubiquitous. Plastics provide advantages in packaging not only to manufacturers but also end-users in terms of ease of storage and handling.

However, evolution comes at a cost. The major menace in the use of plastics is proper disposal. Lack of awareness for adequate segregation of waste from home and hospital setups, and limited facilities for proper treatment of plastic wastes, have added to this bioburden. The degradation or fragmentation of plastics results in macroplastics (>2.5 cm), mesoplastics (0.5–2.0 cm), microplastics (0.5 cm–1.0 µm), and nanoplastics (<1.0 µm) (1).

The real issue is not with the fragments themselves but their capacity to be vectors for transport of hydrophobic organic contaminants (2). These plastics could be of varying chemistries—namely, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyethylene terephthalate, polyamide, polyacrylonitrile, etc. (3). In the context of pharmaceuticals, these organic contaminants are drugs and chemicals that are absorbed or adsorbed to these plastics depending upon their physicochemical properties (4).

Various molecular properties such as dissociation or ionization constant, or partition or distribution coefficient, govern the solubility of a compound and its differential migration into hydrophilic or lipophilic matrices. Once disposed of after their use, these packages—and the microplastic they contain—enter our ecosystem through wastewater treatment plants or degradation of plastic debris (5).

Wastewater treatment plants could be a further source of transmission of microplastics to agriculture fertilizers. This poses a huge bioburden on the ecosystem in terms of bioaccumulation and biomagnification of organic contaminants; again, for purposes of this discussion, these contaminants should be considered drugs. The aging of microplastics further enhances the adsorption of organic compounds (6).

Sources for human exposure to these organic contaminants could be seafood, terrestrial food, drinking water, inhalation, or salt from sea water, meaning that unintentionally, these drugs may ingress the human body through the food chain. Associated health hazards may be evident in the form of skin irritation, respiratory problems, cardiovascular diseases, digestive problems, reproductive issues, and other symptoms (7).

The bigger threat may be in terms of developing antibiotic resistance, which could be driven by genetic modifications in the aquatic ecosystem (8). According to a World Health Organization report published in 2019, fresh water may contain 1 to 1000 particles per liter, while drinking water may contain 0 to 10,000 particles per liter (9).

While efforts are ongoing to understand and control this growing problem, the impact to the wildlife and aquatic ecosystem of ingested, micropollutant-loaded microplastics remains a concern.

1. Blettler, M. C. M.; Ulla, M. A.; Rabuffetti, A. P.; Garello, N. Plastic Pollution in Freshwater Ecosystems: Macro-, Meso-, and Microplastic Debris in a Floodplain Lake. 


2. Santos, L. H. M. L. M.; Rodríguez-Mozaz, S.; Barceló, D. Microplastics as Vectors of Pharmaceuticals in Aquatic Organisms—An Overview of Their Environmental Implications. 

A European Strategy for Plastics in a Circular Economy

; European Commission, 2018.
4. Atugoda, T.; Vithanage, M.; Wijesekara, H.; et al. Interactions Between Microplastics, Pharmaceuticals and Personal Care Products: Implications for Vector Transport. 


5. Zhou, R.; Lu, G.; Yan, Z.; et al. A Review of the Influences of Microplastics on Toxicity and Transgenerational Effects of Pharmaceutical and Personal Care Products in Aquatic Environment. 


6. Moura, D. S.; Pestana, C.,J.; Moffat, C. F.; et al. Aging Microplastics Enhances the Adsorption of Pharmaceuticals in Freshwater. 


7. Klavins, M.; Klavins, L.; Stabnikova, O.; et al. Interaction between Microplastics and Pharmaceuticals Depending on the Composition of Aquatic Environment. 


8. Laganà, P.; Caruso, G.; Corsi, I.; et al. Do Plastics Serve as a Possible Vector for the Spread of Antibiotic Resistance? First Insights from Bacteria Associated to a Polystyrene Piece from King George Island (Antarctica). 

; World Health Organization, August 2019.

Piyush Gupta is an expert pharmaceutical consultant based in Bengaluru, India.

The bio/pharmaceutical industry must address the environmental impact of microplastics, which can act as vectors for organic contaminants, including drugs. These contaminants can enter ecosystems through improper disposal of plastic packaging, leading to bioaccumulation and potential health risks such as skin irritation and respiratory issues. The presence of microplastics in water sources poses a threat to wildlife and may contribute to antibiotic resistance. Efforts are needed to mitigate these risks and understand the long-term effects on ecosystems and human health.

While plastics have revolutionized pharmaceutical packaging, that evolution within the industry has come at a cost.

Microplastics as Vectors of Pharmaceuticals in Ecosystem: A Concern

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

In the first-ever “Two-Minute Mysteries: BioPharma Stories,” Agilent’s Ken Boda shares the mystery of a low reading.

Two-Minute Mysteries: BioPharm Stories - Episode 1: The Mysterious Cause of a Low Reading



In this inaugural episode of the “Two-Minute Mysteries: BioPharma Stories” video series--created in partnership with our sister publication

--Ken Boda, a dissolution product specialist at Agilent Technologies, shares the story of a mysterious low reading.

Ken Boda
Dissolution Product Specialist
Agilent Technologies

Ken works primarily with customers in the US and Canada. He has a wide knowledge of analytical methods, method development, validation, and regulations in the pharmaceutical environment. He enjoys educating people on the science of dissolution and helping customers work through their method challenges.

Specialties: Dissolution Method Development and Validation, Dissolution Failure Investigations, HPLC, UV, Physical Testers, well-versed in USP, FDA, and ASTM regulations in regard to pharmaceuticals, nutritional supplements, and medical devices.

Find Ken on 

*Editor’s Note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.



Hi, my name is Ken Boda. I'm a dissolution product specialist with Agilent Technologies. I wanted to share a little, scientific mystery with you. Oftentimes, when we're working with dissolution and we have a failure, these can present as little mini mysteries to try to do a failure investigation, determine what's going on.

One example of a quick mystery is a customer of ours who had a dissolution with baskets and a disintegrant dosage form, and they had unexplained low results on a particular dissolution bath. They asked us to come out and take a look at it. We brought our 280-DS mechanical qualification system to the site to evaluate the system.

We found that the alignment of the system was good. However, we did note that there was some interesting spikes in vibration over time, and it turned out that the vibration was coming from a refrigerator that was on the same bench top as the dissolution. So what was going on? What was causing those low results?

Well, when we have spikes in vibration in a disintegrant dosage form in basket, we can shake that basket out and we end up having the powder land on the bottom of the vessel, and at the bottom of the vessel, we don't have much mixing. And so, as a result, we have a large amount of drugs sitting at the bottom of the vessel where it can't dissolve.

And that leads us to having low results. This is really important to monitor vibration and dissolution, because it can have a lot of interesting effects. We usually think of vibration causing higher and more variable results, but that's not always the case as evidenced by this basket study. So, thank you, and hope you enjoy the rest.

We highlight the week’s industry news in an easy-to-consume, fun format.

PharmTech Weekly News Roundup - Week of September 15

In this PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage.

Collectively, the week’s coverage discusses the pharmaceutical industry’s recent developments and current regulatory landscape. Read on for recaps of each story we’ve covered.

ABC Farmaceutici to Celebrate Centennial at CPHI Frankfurt

ABC Farmaceutici will commemorate its 100th anniversary

 at CPHI Frankfurt from October 28–30, 2025, unveiling a special logo and hosting an event at its booth. The company, now part of ICE Pharma, has expanded globally into over 50 countries and developed expertise in active pharmaceutical ingredients (APIs), dermo-cosmetics, and ursodeoxycholic acid (UDCA), a treatment for a rare autoimmune liver disease.

CPHI Frankfurt Announces 2025 Pharma Awards Finalists

 have announced finalists across 14 categories, highlighting innovations in synthetic biology, artificial intelligence and sustainable packaging. The awards underscore the industry's shift towards digital tools and green practices, with winners to be revealed at the CPHI Frankfurt opening ceremony on October 28.

Cancer Research UK and Nxera Launch Phase IIa Trial for Immuno-Oncology Drug

Cancer Research UK and Nxera Pharma have begun a Phase IIa clinical trial for HTL0039732

, an investigational small-molecule immunotherapy for advanced solid tumors. The drug targets the EP4 receptor to address tumor-mediated immunosuppression, a different mechanism from traditional checkpoint inhibitors, and will be tested in cancers with high unmet needs, including colorectal and prostate cancers.

Competition Intensifies in MASH Treatment with New Drug Approvals

market for metabolic dysfunction-associated steatohepatitis (MASH) is expanding rapidly

 following the FDA's approval of Madrigal Pharmaceuticals' Rezdiffra and Novo Nordisk's Wegovy. With the MASH market projected to reach $31.8 billion by 2033, major pharmaceutical companies like Eli Lilly, GSK, and Boehringer Ingelheim are advancing their own innovative therapies, creating a highly competitive landscape.

FDA Issues Warnings Over Misleading Drug Promotions

FDA issued warning letters to Eli Lilly, Novo Nordisk, and Hims & Hers Health

 for misleading promotional communications regarding popular weight-loss drugs. The warnings specifically criticized a television program for omitting and minimizing significant risk information for drugs like Mounjaro and Ozempic, signaling heightened regulatory scrutiny of advertising practices across all media platforms.

FDA Approves Enbumyst, a Nasal Spray for Edema

, a bumetanide nasal spray for treating edema associated with congestive heart failure, liver, and kidney disease. Designed as a self-administered outpatient therapy, the nasal spray offers rapid absorption comparable to IV diuretics, potentially reducing hospitalizations and healthcare costs for the 6.7 million Americans with heart failure.

The week's pharma news includes FDA warnings for Lilly and Novo, new drug approvals for MASH and edema, and a look ahead at CPHI Europe.

Feliza Mirasol is the science editor for 

US vaccine policy is expected to fundamentally shift on the back of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) Sept. 18, 2025 vote recommending that children receiving their first immunization dose against measles, mumps, rubella, and varicella (chickenpox) (MMRV) receive separate injections instead of the single, combined four-part vaccine. The decision was made via an 8-3 vote with one abstention, according to published reports (1,2).

The decision advises separating the MMR vaccine from the varicella vaccine for children four years old and younger, which, in other words, recommends against the use of the combined MMRV vaccine (marketed as Merck & Co.’s ProQuad, which was approved by FDA in 2005 [3]). ACIP recommendations typically determine which vaccines are provided free through the US government and influence state laws, as well as shape health insurance coverage.

What is the technical rationale behind ACIP’s decision?

The catalyst for this significant regulatory change appears rooted in epidemiological data concerning the incidence of febrile seizures. Panelists advocating for the split pointed to evidence indicating that the combined MMRV shot carries approximately double the rate of fever-related convulsions in the four-year-old-and-younger age group compared with the separate administration of the MMR and varicella shots (4).

Data indicate the combined shot yields roughly seven to eight febrile seizures per 10,000 children, versus roughly three to four per 10,000 for those receiving MMR and varicella separately. Receiving the MMRV vaccine can trigger an estimated one additional febrile seizure per every 2300 to 2600 children, compared with the MMR vaccine alone (5,6). While febrile seizures occur in 2% to 5% of young children, are generally common, and carry an excellent prognosis (7), some new panel members argued that reducing their incidence is a beneficial public health goal, citing research that suggests potential detrimental effects on neurodevelopment.

In counterpoint, committee member Cody Meissner, MD, professor of Pediatrics at Geisel School of Medicine, Dartmouth stated in one of the published reports, "It’s a very frightening experience, but I think people are very comfortable in saying that a febrile seizure is not associated with any sort of impaired performance or neurocognitive development or school problems" (1).

What concerns exist over patient adherence and disease risk?

A key professional concern for vaccine manufacturers related to separating the vaccine regimen centers around the established benefit of combination vaccines in enhancing patient adherence to the childhood immunization schedule. Experts have warned that increasing the number of vaccinations required could threaten children’s health because it may likely increase the risk of non-compliance (8).

Preventable diseases, such as measles, mumps, rubella, and chickenpox, can be highly dangerous as evidenced by the fact that, prior to the measles vaccine in the 1960s, there were 48,000 annual hospitalizations (9). Opponents of the change emphasized that compliance risks outweigh the benefit of reducing the small incidence of febrile seizures.

"The disadvantage of giving two doses or, as was suggested, separating the two doses is that we know compliance falls. And the advantage of combination vaccines is that children and adults are more likely to complete the vaccine," Meissner said in the published report (1).

What impact will regulatory ambiguity and panel dynamics have on the industry?

Despite the new policy recommendation to split doses, the ACIP subsequently voted 8-1 not to change coverage for the combined MMRV shot within the Vaccines for Children (VFC) program. This subsequent vote to retain VFC coverage for the combined shot led to confusion among committee members regarding whether guidelines would differ based on the child's coverage. This contentious regulatory environment is furthermore heightened by the fact that Health and Human Services Secretary Robert F. Kennedy Jr., who has questioned vaccine safety, recently 

 and replaced them with handpicked advisers, some of whom lack documented vaccine expertise (10).

CDC officials estimate that the practical shift of the new policy may be limited because only about 15% of children in the relevant age group currently receive the four-part shot, according to the CDC, which noted that this figure is already influenced by its previous evaluation and communication of the seizure risk in 2008 and 2009. The ACIP is scheduled to continue its meetings, which will include discussions on COVID-19 vaccines and votes on hepatitis B vaccination timing.

CDC Panel Recommends Multiple Shots for Measles, Mumps, Rubella and Chickenpox Instead of Single Vaccine

. theguardian.com, Sept. 18, 2025 (accessed Sept. 19, 2025).
2. Gardner, J. 

CDC Panel Recommends Splitting Measles, Varicella Shots

, Sept. 18, 2025 (accessed Sept. 19, 2025).
3. FDA. ProQuad Label (accessed Sept. 19, 2025). 

https://www.fda.gov/media/119880/download


4. MacDonald, S. E.; Dover, D. C.; Simmonds, K. A.; Svenson, L. W. Risk of Febrile Seizures After First Dose of Measles-Mumps-Rubella-Varicella Vaccine: A Population-Based Cohort Study. 


5. Klein, N. P.; Fireman, B.; Yih, W. K.; et al. Measles-Mumps-Rubella-Varicella Combination Vaccine and the Risk of Febrile Seizures. 

Information Sheet: Observed Rate of Vaccine Reactions Measles, Mumps and Rubella Vaccines

, May 2014.
7. Tiwari, A.; Meshram, R. J.; Kumar Singh, R. Febrile Seizures in Children: A Review. 

The CDC's Advisory Committee on Immunization Practices (ACIP) has recommended separating the MMR and varicella vaccines for children under four, moving away from the combined MMRV vaccine due to a higher incidence of febrile seizures. This decision, influenced by epidemiological data, aims to reduce seizure risk but raises concerns about potential non-compliance with vaccination schedules. Despite the recommendation, the ACIP voted to maintain coverage for the combined vaccine under the Vaccines for Children program, creating regulatory ambiguity. The policy shift's impact may be limited, as only 15% of children currently receive the combined shot.

CDC panel shifts vaccine policy by discouraging combined MMRV shot for young children due to increased febrile seizure risk.

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