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1rem

There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

Podcast will give an overview of the latest analytical tools and their applications in the drug development market, covering topics such as the current implementation of capillary electrophoresis, the impact of emerging therapies on innovation, and the ethical and regulatory considerations in ongoing drug development.

Dr. Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina.

Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, boasts over 20 years of experience in the biopharmaceutical field, with notable tenures at Pfizer, Hospira, Centre for Marine Bioproducts Development, Stellenbosch University, and the Queensland University of Technology. With a background enriched by a Ph.D. from Stellenbosch University and an MBA from the University of New South Wales, Jan tailors programs spanning pre-clinical to commercial manufacturing phases, enhancing BioCina's business development through his comprehensive industry insight and technical expertise.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.

Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development

Artificial intelligence, machine learning, and novel instruments are helping drug developers evaluate complex data from bioanalytical studies.

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies 

In the conclusion of this 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 Three: Tapping Agentic AI’s Potential

In this continuation of 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 Two: Agentic AI’s Adoption in Life Sciences

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

Optimizing Data Use for Digital Transformation

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

 Benjamin McLeod and Sebastian Lykke Skafte Andersen go behind the headlines to examine the motivations behind recent M&A activity, tariff responses, and more.

Behind the Headlines, Episode 23: Patent Cliff Deals, Tariff Pressures, and the In Vivo Cell Therapy Bet

 is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons that hide behind the headlines.

In episode 23, the panel analyzes how looming patent cliffs, rising trade pressures, and a new wave of in vivo platforms are reshaping the biotech deal landscape. Benjamin McLeod, founder of Convey BIO, and Sebastian Lykke Skafte Andersen, managing director and founder of ClarityNorth Partners, examine how recent headlines signal deeper structural shifts for pharma commercialization and manufacturing strategy.

The panel begins by spotlighting Merck’s $10 billion acquisition of Verona Pharma (1) as a clear example of dealmaking driven by pricing headwinds. With the 

Most-Favored Nation (MFN) executive order

 pushing U.S. drug prices toward European benchmarks, biopharma buyers are racing to acquire late-stage, revenue-generating assets ahead of price compression. As margins come under threat, preemptive M&A is becoming a go-to strategy for portfolio fortification.

In Vivo CAR-T Moves Closer to Center Stage

Attention then turns to the in vivo cell therapy frontier. Gilead’s Kite Pharma recently acquired Interius Biotherapeutics for $350 million (2), adding a modular in vivo CAR-T platform aimed at broadening therapeutic applications and improving scalability. Cindy Perettie, executive vice president at Kite, highlighted the potential for combining Interius’ novel platform with Kite’s established infrastructure to accelerate in vivo therapeutic development.

AstraZeneca’s massive $50 billion U.S. investment

 as a strategic response to escalating U.S. 

, some exceeding 250%. The company’s pivot marks a larger industry trend toward reshoring biomanufacturing as a form of industrial policy, not just portfolio strategy. Beyond portfolio diversification, AstraZeneca’s U.S. expansion includes GLP-1 pipeline growth, CGT infrastructure, and regulatory optimization through increased U.S.-based trials.

Watch the full episode above for more insights into the evolving biopharma landscape and catch up on previous episodes of 

References 
1. Merck to Acquire Verona Pharma, Expanding its Portfolio to Include Ohtuvayre® (ensifentrine), a First-In-Class COPD Maintenance Treatment for Adults and Expected to Drive Growth into the Next Decade. Press Release. Merck. July 9, 2025. https://www.merck.com/news/merck-to-acquire-verona-pharma-expanding-its-portfolio-to-include-ohtuvayre-ensifentrine-a-first-in-class-copd-maintenance-treatment-for-adults-and-expected-to-drive-growth-into-the-next-dec/
2. Kite to Acquire Interius BioTherapeutics to Advance In Vivo Platform. Press release. InteriusBioTherapeutics. August 21, 2025. https://interiusbio.com/press-release/kite-to-acquire-interius-biotherapeutics-to-advance-in-vivo-platform/

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Ask the Expert: Identity Testing on Final Product

 video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss if and when identity testing is necessary to be performed on a final product when the API is sourced from a third party.

“It's an interesting question, because you're going to get the API with a certificate of analysis, and you're going to do the identity and testing on that,” Schniepp ponders. “So I understand that they're trying to get out of redundant testing, and maybe there's a different way to approach it, but at some point in the final product testing, you're going to have to come up with what is the potency of that active ingredient in your final product, which you know you're identifying it. So, I don't know if you can say, ‘my potency test counts as my identity test, and it gives me the exact amount that's in my final product’. Bit, it's usually a fairly simple test. So, I'm not sure what the benefit you gain [from not doing the test]. You're going to spend more time justifying why you're not doing an identity test than the benefit gained from, you know, just doing it.”

Click the video above to watch Sue and Siegfried answer the following question:

“My company sources our API from a third party. Do we have to conduct identity testing on the final product before distribution?”

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of 

Siegfried Schmitt is vice president, Technical at Parexel and a member of 

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss if and when identity testing is necessary to be performed on a final product when the API is sourced from a third party.

Ask the Expert: Identity Testing on a Final Product

Discussion about advancements in flow sensor technologies with PSG Biotech's Michael Franco.

INTERPHEX 2025: Advanced Flow Sensor Technologies Enable More Accurate Measurement

At INTERPHEX 2025, Michael Franco, global sales director at PSG Biotech, spoke with the PharmTech Group about how recent advancements in pharmaceutical flow sensor technology focus on improving measurement accuracy as drug production becomes more expensive and precise. A key development, he notes, is the enhancement of Coriolis single-use flow meters, which now feature a higher turndown ratio. This enhanced feature allows a single sensor to accurately measure both high and low flow rates. With this innovation, inventory needs can be reduced, and sensor usability across various process conditions is extended, which improves sustainability.

“When we talk about high turndown ratio, it's very good for the industry, because with one sensor, you can measure more than just low flows or high flows. So, in terms of sustainability, there's less need for inventory, and the sensor can be used for longer, because it can be operated in different process conditions. [In] terms of the future, we're adding more digital communication platforms so customers can communicate to the sensors in different ways, making sure that the sensors talk to pumps, and to get a really good performance between the two. [Those] are the things that probably are going to be asked more and more from customers,” Franco says.

Looking forward, this integration of digital communication platforms to enhance sensor interoperability is expected to enable better coordination with pumps and optimize system performance. These advancements are increasingly demanded by customers for improved bioprocessing applications, including tangential flow filtration (TFF) and chromatography skids. The ongoing adoption of these technologies as observed at INTERPHEX, notes Franco, highlights their growing importance in pharmaceutical manufacturing.

INTERPHEX 2025 occurred in New York City on April 1–3.

Michael Franco, Global Sales Director, PSG Biotech

Michael Franco leads the PSG Biotech global sales team, focused on strategic business growth, with a strong focus on adding value to PSG Biotech customers, and building meaningful and in-depth partnerships. Mike’s abilities to connect with customers and understand business strategy stem from a rich educational and career experience in key roles in multiple industries:

Prior to Biopharma, Mike worked in several sectors including Aerospace, Industrial, Renewable Energy and Power. He progressed from positions such as Researcher, Applications Engineer, Commercial Engineer, Segment Leader and Regional Sales Manager where he excelled and elevated to his current position as Director of Global Biopharma Sales. Companies that have been graced with Michael’s employed expertise include Syntest Corporation, Panametrics, GE Power Systems, GE Oil and Gas, GE Industrial, GE Energy Services, and AMETEK.

Michael’s education achievements include a Bachelor of Applied Science in Electrical Engineering from Boston University, a Master of Science in Information Technology at Worcester Polytechnic Institute, and a Master of Business Administration with a concentration in Business Administration and Management at the Isenberg School of Management at UMass Amherst.

Michael Franco, global sales director at PSG Biotech, spoke with the PharmTech Group at INTERPHEX 2025 about recent advancements in pharmaceutical flow sensor technology.

Latest Conference

Nicolas Pivet Cytiva discusses automation benefits process development analytics

Process Development Benefits from Automated Analytical Technologies

In an interview with the PharmTech Group, Nicolas Pivet, vice-president and general manager, Technology Solutions at Cytiva, notes that among the challenges in developing a biomanufacturing process is the process analytical technology (PAT) used in that process. Pivet discusses how automation benefits process development, especially when applied to analytics.

“I would say digital documentation is always helping with fast regulatory filing and tech transfer,” Pivet says, adding that, “What we've been experiencing in Cytiva is that many of our customers actually use a platform approach for process development, which is great for speed, but sometimes is not optimized for everything.”

“The introduction of recipe-driven equipment in process development has really enabled 24/7 utilization of labs, so, it's really enhancing the throughput of your lab staff,” Pivet says. The scientist, therefore, with the help of automation, can program lab equipment to rapidly execute experiments and collect samples. “What we've been seeing as well is that SCADA—the supervisory control and data acquisition system—is a layer that allows equipment information to be viewed together. That's why, in Cytiva over the past seven years, we've been developing our Figurate automation offering, which is a wide range of automation solutions and libraries, from historian to control systems with Unicorn [a control software] to SCADA with Wonderware [an automation platform] and to DCS [distributed control system] with Delta V and PlantPAx [types of DCS].”

In the area of PAT, Pivet feels that the bio/pharma industry needs to move faster. In the sensors space, for example, P80 sensors have been seeing an emergence of improved sensing technology. “Measuring CQAs [critical quality attributes], for instance, inline or online is really the holy grail of the biopharma industry right now,” Pivet says. “…The industry needs to get there in being able to measure CQAs inline and helping with real-time release, or right-time release, of the drug product.”

Nicolas Pivet, Vice-President and General Manager, Technology Solutions, Cytiva

Nicolas Pivet is vice-president and general manager, Technology Solutions, at Cytiva, where his ability to find the right creative solution—whether for customers, or when writing songs—is at the root of his delivery-focused mindset. Innovation is second nature to Pivet, which allows him to bring fresh approaches to meeting customer needs. He is a seasoned leader, with laser-sharp customer focus and experience across software and hardware R&D, program management, strategy, service operations, and commercial. Since 2023, Pivet has led Cytiva’s global Automation, Digital and Learning Solutions Business Unit, developing digital solutions enabling fast, flexible, and reliable process development and manufacturing for the biopharma industry. He also leads the Manufacturing Capacity Solutions unit, where Cytiva supports customers with powerful and innovative end-to-end solutions that transform biomanufacturing.

Cytiva's Nicolas Pivet, vice-president and general manager, Technology Solutions, emphasizes how automation benefits process development, particularly in the analytical space.

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The Impact of USP Chapter <86> on Endotoxin Testing

The US Pharmacopeia (USP) published Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents into the

 United States Pharmacopeia–National Formulary (USP–NF) 

The chapter permits the use of non-animal-derived reagents for endotoxin testing and is part of USP’s commitment to expanding the use of animal-free methods and materials (1).

Endotoxins, which are present in the environment, can have dangerous effects if they are contained in pharmaceutical products. Gram-negative bacterial endotoxins are difficult to destroy, according to Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories. “When [endotoxins] do end up in a final product, [and] when that [product] is injected or implanted into a patient, it can lead to what we call a pyrogenic response. What that means is the human body is reacting to this contaminant, and it can cause anything from a mild fever all the way through to death. That's the ultimate circumstance of too much endotoxin. So, therefore, most pharmaceutical products that are tested for endotoxin are those that are injectable or implantable and come into contact with the bloodstream, and therefore have to have low levels of endotoxin.”

Currently, most manufacturers use the limulus amebocyte lysate (LAL) test to perform endotoxin testing. The LAL test is an animal-derived test, and though the animal itself is not tested upon, there is still concern about the use of animals in testing. Therefore, USP has introduced this new chapter to the 

® spoke with Reid to get her perspective on endotoxin testing and how the new USP chapter might impact the pharmaceutical industry.

Click on the video above the watch the interview.

1. USP. Expert Committee Approves Endotoxin Testing Using Non-animal Derived Reagents. Press Release. July 26, 2024.

Pharmaceutical Technology® spoke with Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, to get her perspective on endotoxin testing and USP’s new Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents.

Marianna Tcherpakov, PhD, director of Business Development, CMC Services, at Frontage Laboratories, spoke on the CDMO’s role in tackling complex technical challenges to enable startup biotechs solve scale up problems.

BIO 2024: CDMOs Focus on Complex Technical Challenges to Boost Startup Biotechs

Contract development and manufacturing organization (CDMO) Frontage Laboratories founder Song Li, PhD, who currently holds the position of executive chairman, board of directors, at the company, first set up a testing laboratory in Thorofare, NJ, with a focus on analytical and bioanalytical testing that quickly established a reputation for expertise. That foundation of expertise seems to have stayed fairly well intact, and science—and scientists—driving projects forward appear to be the key selling point for this CDMO, which says of itself, “our scientific knowledge base, technical expertise and reputation for high quality services have been integral to our ability in turning our services into your solutions” (1). In speaking with the company’s staff at BIO 2024, Pharmaceutical Technology Group’s Chris Spivey discerned that the practical upshot for the company has been that Frontage Laboratories often attracts the more vexing or technically challenging projects, and as a result, the company’s teams are now well situated to deal with the more difficult of perplexing projects for which others may not be as well prepared. As an example of the company’s preparedness, it states on the resources section of its website that it uses a next-generation sequencing (NGS)-based method, called the Frontage PGx NGS Test, to rapidly determine the genotype of 300+ genes involved in absorption, distribution, metabolism, and excretion (2).

Talking with Spivey at BIO, Marianna Tcherpakov, PhD, director of Business Development, CMC Services, Frontage Laboratories, at BIO, outlined the general approach the company takes when working with clients. She emphasized that the company’s approach is always customizable and personalized to not only the science the client requires but also to their specific strengths and weaknesses as an organization. “We look at your project as our own product. We therefore offer fast delivery, fast responses to client questions, almost as if we are holding hands … Many come from smaller startups that need a lot of guidance. [This] can be technical, it might be regulatory, but it all relies on our very strong scientific base,” Tcherpakov said. “We are passionate about technology,” she added.

Many of the PhD staff at Frontage Laboratories have come from other companies in the industry, and Tcherpakov pointed out that these past experiences and learnings are often brough to bear on the current project challenge. “We understand how stressful it can be for the smaller biotech, and even middle-sized [biotechs], when you have a lot of deadlines. You have clinical trials submissions coming up, and you need to be on top of everything, and fast,” she said.

Touting their scientific backbone Frontage Laboratories advertises itself as “more than a CRO”, in that it is also a “full global pharmaceutical development organization. Frontage Laboratories offers a comprehensive suite of drug discovery and development services including chemistry, DMPK [drug metabolism and pharmacokinetics], preclinical safety/toxicology, and clinical trial services with strategic and regulatory support to effectively bring new lead candidates through the IND [investigational new drug] stage to Phase II” (3).

BIO 2024 was held on June 3–6 in San Diego, Calif.

1. Frontage Laboratories. Services & Solutions. 

 (accessed August 21, 2024).
2. Frontage Laboratories. Resource Library. 

 (accessed August 21, 2024).
3. Frontage Laboratories. About Frontage. 

Marianna Tcherpakov, PhD, is the director of Business Development, CMC Services, at Frontage Laboratories. Image courtesy of Frontage Laboratories.

Shawn Li, principal scientist at Merck & Co., known as MSD outside the Unites States and Canada, talked about the importance of properly characterizing HCPs in the biomanufacturing process.

AAPS PharmSci 360: The Importance of HCP Analysis in Biomanufacturing

® spoke with Xuanwen (Shawn) Li, PhD, Principal Scientist at Merck & Co., known as MSD outside of the United States and Canada, during AAPS PharmSci 360 about the importance of properly analyzing host cell proteins (HCPs) during the biomanufacturing process.

“Host cell proteins are process-related impurities in biopharmaceutical manufacturing. The identification and control of a high-risk host cell protein in biopharmaceutical development is critical to ensure biopharmaceutical product quality and shelf life,” Li stated. For example, he explained, certain HCPs can have direct biological effect, and some HCPs can degrade the drug product or formulation excipients such as polysorbate. “The host cell protein issue can lead to significant delay or product withdrawal … Therefore, it's extremely important to understand how to properly analyze host cell proteins in biopharmaceutical manufacturing,” Li said.

, scheduled on Wednesday, Oct. 23, at 3:45 pm MT (2:45 pm PT, 5:45 pm ET), he focuses on the identification and control for one of a group of high-risk HCPs called the polysorbate-degradative enzyme. With an analytical toolbox developed at Merck, the company can better understand polysorbate degradation in biologics. One assay Li highlights in his talk is activity-based protein profiling (ABPP). “In short, ABPP can overcome the dynamic range issue of trace levels of high-risk host cell protein to drug substance and really enable the identification of those low abundance enzymes, while also providing activity information,” he said.

Attendees can visit Merck at Booth #3344. AAPS PharmSci 360 is taking place Oct. 21–23 at Salt Lake City, Utah.

Xuanwen (Shawn) Li, PhD, Principal Scientist, Merck & Co.

Shawn Li is a principal scientist and scientific supervisor in the Analytical Research & Development, Mass Spectrometry group at Merck & Co. Inc. His research is focused on mass spectrometry-based biologics and vaccine characterization for chemistry, manufacturing, and controls (CMC) development and regulatory submission. Prior to joining Merck in 2018, Li worked as a research scientist at Eli Lilly and Company on protein characterization. Before his industry career, Li was a director of the mass spectrometry facility at the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania. Li received a PhD in proteomics at the Hunan Normal University in China and completed his post-doctoral training in clinical pharmacology and bioanalysis at the University of Pennsylvania.

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Latest News

Biologics Quality Control: The Growing Need for Accessible Proteomics