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Outsourcing Partnerships Fuel Global Biopharma Discovery and Scale-Up

Drug Digest February 2026 

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BMS and Oxford BioTherapeutics Partnership on T-Cells

On April 9, 2026, Oxford BioTherapeutics announced a multi-year collaboration with Bristol Myers Squibb focused on the discovery and development of T-cell engager therapies for solid tumors.

 According to the agreement, Oxford BioTherapeutics will use its OGAP-Verify platform to find specific targets in solid cancers and create new T-cell engager molecules. Bristol Myers Squibb will then lead subsequent research, development, and commercialization activities.

The deal places target identification and the generation of development candidates within Oxford BioTherapeutics before handoff to Bristol Myers Squibb for the later-stage work.

 That division of labor reflects a new industry trend that is shifting toward more modular collaboration models, in which specialized platform technologies are brought in at the discovery and preclinical stages rather than developed in-house.

What Does the OGAP-Verify Platform Contribute?

The OGAP-Verify platform is designed for highly sensitive identification of oncology targets with attributes that support downstream drug development, with a particular emphasis on tumor selectivity.

 Oxford BioTherapeutics' remit extends beyond target identification to include the design and delivery of development candidates, a scope that signals the platform's positioning as less of a discovery tool than a preclinical development tool.

"This new partnership builds on the proven strength of our platform to identify and validate highly differentiated, tumor-selective targets and reflects the growing confidence in our ability to translate that science into development-ready therapeutic candidates," said Christian Rohlff, chief executive officer, Oxford BioTherapeutics, in a press release.

T-cell engagers for solid tumors remain a challenging area of oncology drug development.

Unlike hematological malignancies, solid tumors present significant obstacles around target accessibility, tumor microenvironment immunosuppression, and on-target off-tumor toxicity. The emphasis on tumor-selective targets in this collaboration speaks directly to those challenges.

Why Does the Timing of This Deal Matter for the Broader Field?

This agreement is the third major pharmaceutical collaboration Oxford BioTherapeutics has entered in the past twelve months, following partnerships with GSK and Roche in 2025.

The pace these deals are being drafted suggests that large pharmaceutical companies are actively seeking external platform capabilities for oncology target discovery rather than relying solely on internal research infrastructure.

"Collaborating with Bristol Myers Squibb, a global leader in oncology, represents an important milestone for OBT and underscores the momentum behind our partnerships with leading pharmaceutical companies," said Rohlff, in the press release.

 "By combining OGAP-Verify's discovery and validation capabilities with Bristol Myers Squibb's expertise in translating oncology innovation into clinical and commercial outcomes, we are confident that together we can advance a new generation of innovative cancer therapies that have the potential to make a meaningful difference for patients."

Deals at this stage are often early signals of what assets may eventually require scale-up and manufacturing support.

 Biologics-based T-cell engagers, including bispecific formats, carry well-documented complexity in terms of expression systems, purification, and formulation. Monitoring which targets and molecular formats emerge from collaborations like this one can inform capacity planning and technology readiness well ahead of late-stage development timelines.

How Else Is BMS Approaching the Cancer Care Pathway?

The T-cell engager collaboration with Oxford BioTherapeutics sits at the discovery end of oncology drug development, but Bristol Myers Squibb is also investing in infrastructure that shapes the detection of cancer.

 aims to accelerate early detection of lung cancer by deploying AI radiology algorithms through Microsoft's imaging network. The system is designed to help detect surface lung nodules that might otherwise go unnoticed, and to track patients with incidental findings through follow-up care pathways. This is an area where current loss-to-follow-up rates exceed 50%. The signal is clear, that Bristol Myers Squibb is investing in its oncology pipeline at multiple levels, they are looking to cover novel target identification through to the point of diagnosis.

Oxford BioTherapeutics. Oxford BioTherapeutics Enters Strategic Collaboration with Bristol Myers Squibb to Discover and Develop Next-Generation T-cell Engagers for Solid Tumours. Oxford BioTherapeutics; April 9, 2026. 

https://oxford-biotherapeutics.lon1.cdn.digitaloceanspaces.com/OBT-BMS-2026-04-09.pdf

Bristol Myers Squibb. Bristol Myers Squibb announces collaboration with Microsoft to advance AI-driven early detection of lung cancer. Bristol Myers Squibb. Published January 19, 2026. 

https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Announces-Collaboration-with-Microsoft-to-Advance-AI-Driven-Early-Detection-of-Lung-Cancer/default.aspx

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Oxford BioTherapeutics and Bristol Myers Squibb formed a multi-year alliance to discover and advance solid-tumor T‑cell engagers. Oxford will apply OGAP‑Verify to identify tumor-selective antigens and generate development-ready candidates, with BMS leading later research, clinical development, and commercialization. The structure reflects modular partnering to access specialized discovery platforms amid persistent solid-tumor hurdles, including target accessibility, immunosuppression, and on-target off-tumor risk. The deal also flags future biologics manufacturing complexity and complements BMS investments in AI-enabled lung-cancer detection and follow-up pathways overall.

BMS and Oxford BioTherapeutics partner to develop tumour-selective T-cell engagers, signalling pharma's growing reliance on specialist discovery platforms.

How Pharma Is Outsourcing Oncology Target Discovery in 2026

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan Schniepp, Regulatory Compliance Associates Inc.

Susan Schniepp, Regulatory Compliance Associates Inc., shared her insights on the transformative role of emerging technologies in drug manufacturing. Having participated in the planning committees for P

, Schniepp is at the forefront of introducing new technologies like digital twins and artificial intelligence to the industry.

Check out the 3-part video interview with Schneipp:

Digital Twins and the Future of Pharma Validation

Identifying Data Integrity Hotspots Using AI Technology

PharmTech: How Do You Define a Digital Twin in the Context of Pharmaceutical Manufacturing?

Schniepp: My understanding of a digital twin is that it is a system designed to mimic exactly what you have put into live operation. It runs alongside your actual production line. Potential issues come when the two systems, the physical and the digital, begin to divert from one another. If they are no longer in sync, it triggers a specific response from the team, such as a new validation, a technical correction, or another corrective activity to bring them back into alignment.

How Does This Tech Help Address Concerns of Data Integrity?

Data integrity is a major concern as we move away from traditional paper systems or middle electronic systems. In those older models, humans handled every document and performed every approval manually. Now, we use digital twins to identify hotspots, specific areas where there is a high potential for data integrity violations based on how documents are being handled. Once the AI identifies these risks, the human staff can shore up"the system to prevent a violation from ever actually occurring.

How Does AI Change Workflow Compared to a Middle Electronic System?

A middle electronic system is like Documentum, where you use electronics to move files around, but a human still has to physically look at and approve everything. With AI and machine learning, we are allowing the machine to do much more. The system itself collects the data and assures its correctness. The human's role shifts from doing the primary approval of every detail to reviewing the data the digital twin or system has already aggregated.

How Does AI Impact the Batch Release Process?

This is a significant shift for the industry. AI acts like one centralized brain that compiles information from various sources that a person would normally have to hunt for manually. The AI creates a dossier for the batch, noting that parameters were met and identifying any deviations. It can then essentially tell the human, "All of these things related, and there were no deviations. You can release this batch.” This speeds up the process significantly because the human professional is reviewing a summarized dossier rather than starting the data collection from scratch.

What Happens When the Human Professional Disagrees with the Machine's Assessment?

We treat a conflict between the human's opinion and the machine's data as a deviation. Because our industry relies on Corrective and Preventive Action systems, this discrepancy prompts a formal investigation to determine why these two events are conflicting. The traditional model is to investigate the root cause. Since the technology is still so new, I believe the human should take precedence. The investigation should focus on why the digital twin conflicts with the human, though we may occasionally find that the human was actually the one who was wrong.

Do You Have Concerns About The Human-In-The-Loop Model?

The industry is currently struggling with exactly where to place the human in the loop to be most efficient. My concern is that at some point, the machine will absorb so much data and learn so much faster than a person can that it will become more capable than the human. I worry that the human will be out of the loop eventually. However, for now, the human must remain the final decision-maker, absorbing the data provided by the AI to make the final call on whether a batch is safe for release.

Emerging manufacturing technologies are reshaping validation, data integrity assurance, and batch release decision-making. Digital twins are positioned as parallel, continuously updated models of live operations that flag divergence requiring corrective action, revalidation, or technical remediation. AI/ML shifts quality workflows from manual document review toward automated data aggregation, verification, and risk-based identification of data integrity hotspots. For batch disposition, AI can compile cross-system evidence into a release-ready dossier, accelerating timelines. Disagreement between human judgment and machine output is treated as a deviation triggering CAPA-driven investigation, with human precedence maintained.

Susan Schniepp discusses how AI and digital twins speed up pharma batch release and detect data integrity issues while maintaining human oversight.

Managing Deviations Between Humans and Digital Twin Data

FDA Approves First Tablets For Type 2 Diabetes

On April 7, 2026, the FDA granted approval to multiple generic-drug applicants for Farxiga (dapagliflozin) tablets, the first generics featuring the compound to reach the US market.

 The approvals cover two indications, the primary being reducing the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus who have either established cardiovascular disease or multiple cardiovascular risk factors. It is also an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Type 2 diabetes is a chronic condition that develops over many years, occurring when the body does not use insulin well and cannot keep blood sugar at normal levels.

 More than 40 million Americans have diabetes with 90% to 95% of that population having type 2 diabetes.

Farxiga works as a sodium-glucose cotransporter 2 inhibitor, which reduces the reabsorption of glucose and sodium in the kidneys.

 The tablets are available in 5 mg and 10 mg strengths, with bioequivalence to the reference listed drug required as a condition of approval.

What Safety and Labeling Requirements Apply to These Generic-Drug Applicants?

Farxiga is contraindicated in patients with a history of a serious hypersensitivity reaction to dapagliflozin or any of the excipients.

 Warnings include diabetic ketoacidosis in patients with type 1 diabetes mellitus and other ketoacidosis, and volume depletion. The most common side effects reported in clinical trials were female genital mycotic infections, nasopharyngitis, and urinary tract infections. Healthcare providers should review the full prescribing information for complete safety and dosing information, and manufacturers should ensure their labeling reflects the full scope of these requirements before commercialization.

The full list of approved applicants is available through the Approved Drug Products with Therapeutic Equivalence Evaluations.

 Given that approvals were granted to multiple manufacturers simultaneously, companies should anticipate a competitive launch environment and plan production schedules and market entry strategies accordingly.

How Are Recent Type 2 Diabetes Approvals Reshaping Injectable Treatment Development?

While the generic dapagliflozin approvals mark a significant moment for oral glucose-lowering therapy, the injectable insulin space is undergoing a parallel shift.

 On March 26, 2026, the FDA approved Awiqli (insulin icodec-abae) injection 700 units/mL, the only once-weekly, long-acting basal insulin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The approval is supported by the Onwards phase IIIa clinical program, which comprised four randomized, active-controlled, treat-to-target trials in approximately 2680 adults with uncontrolled type 2 diabetes.

 The program evaluated once-weekly Awiqli against daily basal insulin and demonstrated efficacy in the primary endpoint of A1C reduction across the trial program. The safety profile was consistent with the daily basal insulin class, with common adverse events including hypoglycemia, injection site reactions, and weight gain.

Awiqli is administered at a concentration of 700 units/mL using a dedicated pen injector, a delivery system designed to minimize the risk of dosing errors.

 The prescribing information includes specific guidance around pen use, dose selection, and the risk of mix-ups with other injectable products.

"Research supports weekly injectable diabetes medications can be associated with improved patient adherence," Julio Rosenstock, MD, a principal investigator for the ONWARDS trial program, stated in a press release.

 "Having a weekly basal insulin option like insulin icodec-abae may reshape insulin management in adults with type 2 diabetes, giving them a routine that feels more manageable as they work toward their blood sugar goals."

U.S. Food and Drug Administration. FDA approves first generic dapagliflozin tablets. Published April 6, 2026. Accessed April 8, 2026. 

http://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generic-dapagliflozin-tablets

Novo Nordisk A/S. Awiqli approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. Published March 27, 2026. Accessed April 8, 2026. 

https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-awiqli-the-first-and-only-once-weekly-basal-insulin-treatment-for-adults-with-type-2-diabetes-302726839.html

FDA approvals introduced the first US generics of dapagliflozin tablets (5 mg, 10 mg) for type 2 diabetes, covering heart failure hospitalization-risk reduction in high cardiovascular-risk adults and adjunctive glycemic control. Bioequivalence to the reference listed drug is required, alongside full alignment with contraindications, warnings, and adverse-reaction labeling. Concurrently, insulin development advanced with approval of once-weekly insulin icodec-abae (Awiqli) 700 units/mL, supported by the ONWARDS phase IIIa program showing A1C lowering comparable to daily basal insulins.

The FDA approved the first generic dapagliflozin tablets, opening a competitive US market for pharma manufacturers and generic-drug developers.

FDA Approves First Generic Dapagliflozin Tablets

Wilber Cruz is senior QC Microbiology manager at Abzena.

Wilbur Hightower is senior director, head of Site Quality at Abzena.

Vaishali Shah is previously head of Site Quality at Abzena.

Unidentified microbiologist is open the cleanroom door to enter the room in clean area of microbial laboratory in pharmaceutical factory, concept of science, healthcare and safety operation. | Image Source: ©Sukjai Photo - stock.adobe.com

Biopharmaceutical manufacturing and microbiology testing are undergoing a structural shift driven in part by greater investment in advanced therapies, which are intrinsically linked to a more complex regulatory environment. The pressure to both develop these complex therapies and accelerate timelines is fundamentally changing the definition of effective microbial risk control. Consequently, quality control (QC) microbiology is transforming from a supportive role focused mainly on end-product testing into a strategic capability that actively guides facility design, process management, and product lifecycle planning.

Traditionally, microbiology was defined by sterility tests, bioburden assays, endotoxin measurements, and isolated environmental monitoring results, often interpreted days after production events had occurred. Today, the emphasis is shifting toward proactive, data-driven contamination control strategies that integrate rapid microbiological methods (RMM), real-time environmental monitoring, predictive analytics, and cross-functional collaboration. This means that QC microbiologists are now expected not only to detect contamination but to anticipate and prevent it.

In this article, the authors explore the growing need for microbiology QC evolution through technological innovation, facility and infrastructure design, workforce capability, and regulatory expectations. They also look ahead to the future of microbiology testing within contamination control strategies, where automation and new operating models will help redefine how microbial quality is managed.

From Reactive Testing to Proactive Control

The traditional view of QC microbiology was predominantly diagnostic and retrospective. Sterility or bioburden tests answered a binary question with pass or fail, long after manufacturing steps were complete, and environmental monitoring data were periodically compiled and reviewed mainly to satisfy regulatory expectations.

In contrast, modern contamination control strategies position microbiology as a continuous, lifecycle-spanning function. QC microbiologists now help to define contamination control strategy (CCS) documents and participate in risk assessments for new facilities, equipment, and processes. They also design and refine environmental monitoring programs and lead or support deviation investigations and root cause analyses.

The following key factors have driven the evolution of the role of QC microbiology:

More complex modalities. A growing number of advanced biologics, biosimilars, and bioconjugates are entering the development pipeline. These therapies are inherently more sensitive to contamination but often offer few, if any, opportunities for terminal sterilization, making proactive microbial control essential.

To bring therapies to patients sooner and demonstrate a return on investment to investors, developers are targeting shorter and more efficient release timelines, reducing the feasibility of relying solely on traditional, slow microbiological assays.

Regulatory expectations. Regulators increasingly expect holistic, risk-based contamination control strategies supported by robust environmental monitoring, scientifically justified sampling plans, and a strong foundation in data integrity.

How is Technology a Catalyst for Modern Microbiology?

To keep pace with advanced modalities and increasingly dynamic manufacturing environments, organizations must embrace the emerging tools and approaches that are redefining QC microbiology. This transformation is enabled by advances in rapid detection technologies, real-time environmental monitoring, automated laboratory workflows, and digital data systems. These work together to shift microbiology from a reactive testing function to a proactive foundation of contamination control that can support the evolving needs of biopharma.

Reducing bottlenecks through rapid testing technologies

. RMMs are central to the modernization of QC microbiology, offering a meaningful shift away from traditional culture-based assays that require prolonged incubation times. These technologies encompass a range of advanced detection approaches, including:

Fluorescence or luminescence-based systems that identify microbial growth more quickly

Flow cytometry platforms capable of rapid enumeration

Molecular techniques such as polymerase chain reaction (PCR) for detecting contaminants like mycoplasma

Together, these innovations can accelerate testing, as well as enhance sensitivity and specificity.

By shortening time-to-result, RMMs help alleviate bottlenecks in batch release, enable more responsive deviation management, and deepen process understanding through richer, more immediate data. For therapies with narrow release windows or patient-specific timelines, these time savings can directly influence treatment availability and patient outcomes.

Successfully integrating RMMs requires teams to conduct method suitability studies that account for product-specific characteristics, develop validation strategies aligned with regulatory and pharmacopeial expectations, and generate defensible comparability data against compendial methods. Equally important is ensuring that laboratory personnel are trained on new instruments and the analytical frameworks that accompany these technologies.

. Although environmental monitoring has long been a cornerstone of contamination control, the way data are collected and used is changing as programs increasingly rely on:

Continuous or high-frequency monitoring of cleanrooms and water systems

Inline instrumentation measuring parameters, such as conductivity and microbial load in utilities

Electronic management systems that consolidate and trend results across rooms, lines, and time periods.

Instead of treating environmental monitoring as a tool to produce static records, organizations are using it for dynamic decision-making. Trend analysis can reveal slow shifts in facility performance, recurrent weak points in cleaning or disinfection routines and associations between specific activities and microbial excursions.

When QC microbiologists have timely access to this information, they can recommend targeted interventions, including revising cleaning frequencies, retraining operators, adjusting sampling points, or reviewing facility conditions before issues affect product.

Automation and digitalization of QC workflows. 

Automation is increasingly woven into microbiology operations. Robotic sample handling, automated plate pouring and streaking, digital plate reading, and integrated incubators can reduce manual touches, leading to improved consistency and data integrity.

Digitalization can further enhance these advances by ensuring that data are captured directly into laboratory information management systems (LIMS) or environmental monitoring systems. Integrated audit trails provide transparent, traceable records that support regulatory inspection readiness, while dashboards and visualization tools give teams real-time insight into operational performance, enabling faster, more informed decision-making.

Microbiology labs built or expanded in recent years often reflect these priorities, with layouts designed around unidirectional flow, segregation of high-risk activities (such as sterility testing), and space to accommodate instruments and automation platforms. The physical infrastructure increasingly supports advanced QC workflows.

Embedding microbiology into the built environment

. A robust contamination control strategy begins with facility design. Decisions about zoning, air handling, pressure cascades, and flows of people and materials fundamentally shape microbial exposure risk.

Microbiologists are now more actively involved in facility planning, reviewing architectural drawings through the lens of contamination control to ensure that cleanroom layouts, zoning, and adjacency support microbial risk reduction. Their input extends to the following:

Advising on room classifications and pressure cascades

Identifying optimal locations for environmental monitoring sampling points in both utilities and cleanrooms

Supporting the selection of equipment and surface finishes that can be effectively cleaned and disinfected.

This early engagement helps embed microbial control into the facility’s foundational design rather than relying solely on procedural safeguards later in the lifecycle.

Within the wider facility, the microbiology lab itself is increasingly recognized as a critical asset that must be appropriately resourced and segregated. Common themes of segregated and scalable QC labs include:

Dedicated sterility suites with controlled access and unidirectional workflows

Segregated spaces for different test types, such as mycoplasma, endotoxin and bioburden

Support areas for preparation and decontamination, minimizing cross-contamination risks

Biosafety considerations, especially when working with live viral vectors or high-risk organisms.

Investing in QC lab infrastructure like this demonstrates a move away from minimal microbiology spaces toward purpose-built laboratories designed with contamination control and regulatory expectations in mind.

Microbiological control does not end once a cleanroom is commissioned. It continues throughout the facility’s lifecycle. Equipment upgrades, layout adjustments, new processes, and shifting production volumes can all influence microbial risk, making ongoing oversight essential.

Lifecycle management involves regularly reviewing environmental monitoring data to ensure performance remains within expectations, participating in change control assessments when facility or process modifications are proposed, and reassessing sampling locations and frequencies as usage patterns evolve. Input from QC microbiologists can also inform requalification protocols and documentation. By treating cleanroom performance as a dynamic parameter rather than a fixed state, organizations can adapt their contamination control strategies to real-world operational changes.

How Does the Workforce and Culture Impact Microbial Control?

Technology and infrastructure changes are only effective if organizations also invest in people, as QC microbiologists are expected to combine traditional microbiological expertise with additional competencies, including the following:

Understanding and applying risk management principles

Designing and interpreting validation studies

Using digital tools for data analysis, visualization, and reporting

Communicating effectively with engineers, production staff, and regulators

Contributing to cross-functional investigations.

No matter how advanced the technology or how modern the facility, contamination control ultimately depends on human behavior. Gowning practices, aseptic manipulation, adherence to procedures, and attention to detail all play crucial roles.

QC microbiologists can act as catalysts for a strong contamination control culture by helping teams understand the real-world implications of microbial data. This often involves training operators on how environmental results relate to product quality, translating abstract trends into practical guidance, and engaging directly with manufacturing staff through routine walkthroughs. Their presence on the floor helps reinforce good aseptic behaviors and creates opportunities for real-time coaching.

When QC microbiology is viewed as a collaborative partner rather than an auditor, teams are more likely to communicate openly and seek support before small problems escalate. Sharing lessons learned from past contamination events further strengthens trust and collective ownership of microbial control.

How Is Innovation Aligned with Regulatory Compliance?

Regulatory guidance across major regions has increasingly emphasized risk-based, science-driven approaches to contamination control. Agencies expect manufacturers to maintain a documented contamination control strategy that integrates facility, process, and microbiological controls. This justifies their environmental monitoring programs with scientifically sound data and provides rationales when adopting new technologies such as RMMs.

A key example of this is the revision to the European Union’s good manufacturing practice (GMP) Annex 1 guideline, which made a holistic, facility-wide contamination control strategy mandatory.

 The revised guidance also explicitly encourages the use of appropriate innovative technologies, such as restricted access barrier systems (RABS), isolators, robotic systems, and rapid microbial testing and monitoring systems, as a proactive means to increase product protection and rapidly detect contaminants.

However, the adoption of new microbiological technologies must be supported by clear, defensible validation. Key elements typically include the following:

Well-defined acceptance criteria and statistical approaches

Side-by-side comparison with reference or compendial methods

Assessments of robustness, precision, and detection limits

Evaluation of matrix effects or potential interference

Ongoing performance monitoring after implementation.

When approached in this structured way, technological change can enhance microbiological capability, reduce operational risk, and strengthen regulatory confidence in the maturity of a company’s quality systems.

What Is Tthe Future of Microbiology in Contamination Control

As more microbiology data are increasingly captured electronically and linked with process and facility information, new analytical possibilities emerge. Instead of focusing only on what has already happened, organizations can begin to forecast where issues are likely to arise.

Potential future developments include the following:

Predictive models that identify emerging environmental trends before excursions occur

Risk scores for cleanrooms, shifts, or operations based on historical performance and real-time data

Prescriptive alerts suggesting targeted interventions, such as intensified cleaning or focused operator retraining.

As advanced modalities continue to gain traction, microbiology testing strategies will need to evolve accordingly. Microbiologists will be required to tailor environmental monitoring programs to smaller, highly specialized production areas, implement ultra-rapid methods to support time-critical release testing, and shape contamination control strategies that reflect the high operator involvement and complex manual steps common to many of these processes. Together, these efforts will ensure that microbial oversight keeps pace with the unique demands of next-generation therapies.

Collaboration with External Microbiology Experts

Not every organization will have the capacity to internally support all aspects of advanced microbiology — from specialized methods to complex validations and state-of-the-art laboratories. Collaboration with external development and manufacturing partners can help bridge gaps in expertise, capacity, or technology.

When selecting and working with such partners, companies should look for the following:

Demonstrated microbiology and contamination control capabilities

Experience implementing and validating rapid and automated methods

Robust quality systems and data integrity practices

Openness to joint risk assessments and transparent communication.

These collaborations can accelerate the adoption of best practices, reduce implementation risk, and provide access to specialized infrastructure without requiring immediate capital investment.

Building a Holistic Approach to Microbiology Control

The evolution of microbiology testing within contamination control strategies reflects broader changes across the biopharmaceutical sector. As therapies become more complex, timelines tighten, and regulators expect more holistic, risk-based control, QC microbiology has moved from a narrow, reactive role to a central, strategic one.

Future-ready contamination control will likely be characterized by rapid methods, real-time environmental insight, advanced automation, and predictive analytics. These developments will all be underpinned by thoughtfully designed facilities, skilled microbiologists, and a culture that treats microbial quality as everyone’s responsibility. Organizations that invest in these areas and that leverage both internal capabilities and external partnerships will be best positioned to deliver safe, high-quality therapies reliably and efficiently in the years ahead.

European Commission. Revision - Manufacture of Sterile Medicinal Products. The European Commission. 

https://health.ec.europa.eu/latest-updates/revision-manufacture-sterile-medicinal-products-2022-08-25_en

Wilber Cruz is senior QC Microbiology manager at Abzena, Wilbur Hightower is senior director, head of Site Quality at Abzena, and Vaishali Shah is previously head of Site Quality at Abzena.

QC microbiology is shifting from retrospective end-product testing to a strategic, lifecycle function embedded in contamination control strategy, facility design, and process governance. Advanced modalities, compressed release timelines, and heightened regulatory expectations are accelerating adoption of rapid microbiological methods, real-time environmental monitoring, automation, and digital data ecosystems. Effective modernization requires rigorous validation and comparability to compendial methods, robust data integrity, and workforce upskilling in risk management and cross-functional influence. Future-state programs will increasingly leverage predictive analytics and external partnerships to prevent excursions proactively.

This article highlights how quality control microbiology is evolving into a proactive, integrated component of modern contamination control strategies across the biopharmaceutical lifecycle.

Building a Future-Ready Contamination Control Strategy with Microbiology Testing

Joseph Zeleznik is technical product director, IMCD US

Sydney Badger is a Technical Development Manager at IMCD. With over seven years of experience in the pharmaceutical excipient industry, Sydney has a strong background in oral solid dosage forms and formulation development. Leveraging her previous experience as an R&D formulator, she brings application-oriented technical expertise to her current role.

Dr. Manish Ghimire is the Director of Technical Development – North America at IMCD. Manish brings over 20 years of experience in pharmaceutical R&D and technical marketing, with deep expertise in solid dosage forms and advanced formulation strategies. He is a recognized thought leader known for translating complex scientific concepts into practical, commercially relevant solutions.

n-nitrosodimethylamine molecular structure, 3d model molecule, dimethylnitrosamine, structural chemical formula view from a microscope

The pharmaceutical industry is faced with balancing science and innovation with patient safety. Among issues affecting drug product manufacturers, nitrosamine impurities have a unique focus due to their inherent risk to patient health. Why the concern? Evidence shows nitrosamines to be carcinogenic and associated with numerous cancer forms, including esophageal, stomach, liver, lung, and bladder.

 Still, other cancer forms, such as nasopharyngeal, colorectal, and brain, may be attributed to nitrosamine exposure.

 With this in mind, it is important to understand how nitrosamines form.

Pharmaceuticals — APIs and excipients — and their manufacturing processes can create an exposure risk. It is here that pharmaceutical companies have the ability to limit patient nitrosamine exposure.

The nitrosamine issue first emerged in June 2018, when N-nitrosodimethylamine (NDMA) was detected in valsartan. This was followed in the larger group of sartans in July 2018. Ranitidine and metformin followed in 2019.

 The initial focus was on tablets; however, other routes of administration, such as topical, transdermal, and parenteral, may also be a nitrosamine exposure risk. At risk APIs include secondary and tertiary amines and some amides.

Nitrosamine formation has been studied by industry, academia, and regulators hoping to better understand nitrosamine formation. Research shows that nitrosamines form through complex chemical pathways involving nitrosating agents (

Figure 1. Recognized Nitrosamine Formation Pathway. Figure courtesy of the authors. 

From the studies, stakeholders have identified seven nitrosamine compounds (

), specifically N-nitroso compounds (NOCs) associated with an increased health risk.

Figure 2. Seven Known Nitrosamine Compounds. Figure courtesy of the authors.

Today, more than 300 APIs have a potential for nitrosamine formation (


While some drug products have been withdrawn from the market, not all have. Regulators have worked with industry to determine acceptable exposure levels and has published acceptable intake levels that vary from 26.6 ng/day to 1500 ng/day (

 The European Medicines Agency (EMA) has also established acceptable intake levels through their own studies as have PDMA (Japan), Health Canada, TGA (Australia), NMPA (China), and ANVISA (Brazil).

Table I: APIs Identified as Having Potential Nitrosamine Formation

Nitrosamine impurities represent a high-priority quality and safety risk because many are potent carcinogens and can form during API/excipient manufacture, processing, storage, or from packaging. Following NDMA findings in valsartan (2018) and later ranitidine and metformin, scrutiny expanded beyond tablets to topical, transdermal, and parenteral products. Formation involves nitrosating species (eg, nitrites, NOx-derived acids) reacting with susceptible amines/amides; >300 APIs are potentially at risk. Acceptable intakes are nanogram/day-range and jurisdiction-specific. Mitigation emphasizes risk assessment, excipient/process selection (low-nitrite grades, dry processing), solvent/water controls, and scavengers; IPEC provides an excipient questionnaire.

Understanding how factors, such as excipient choice, affect nitrosamine formation is essential to developing safer, lower-risk pharmaceutical formulations.

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