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1rem

Podcast will give an overview of the biosimilars market. Industry experts will discuss regulatory controls, pricing pressure, the state of the healthcare industry, and other factors affecting the uptake of biosimilars in the market. Manufacturing challenges as well as current and future needs will also be discussed. Experts will also highlight technological innovations, such as digitalization technologies, and their role in facilitating analytical characterization and manufacturing controls for biosimilars.

Zara Bukhari, PhD student, Biochemistry, University of the Pacific, Stockton, California

Zara Bukhari completed a master’s degree in engineering at Birla Institute of Technology and Sciences, India, with an internship at Biocon Biologics, focusing on Semglee (insulin glargine-yfgn). This experience sparked Bukhari’s interest in the pharmaceutical industry. Subsequently, she worked as a bioprocess engineer at Biocon Biologics for six years, contributing to the design of purification platforms for biosimilars and innovator biologics. Notably, she was involved in a validation study leading to the successful biologics license application filing of Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab), offering her insights into regulatory requirements and the biosimilars market. Bukhari is currently pursuing a PhD in biochemistry, specializing in ubiquitin biology at the University of the Pacific, Stockton, Calif. Through her PhD, Bukhari aspires to contribute valuable insights into the role of ubiquitination in regulating the cellular proteome and its broader implications in diseases to advance scientific understanding and potentially aid the scientific community in identifying novel drug targets.

John Gabrielson, Senior Vice-President, Biosimilars, and Head of Business, JSR Life Sciences

John Gabrielson is senior vice-president, Biosimilars, and head of Business for JSR Life Sciences. He is a seasoned executive, company builder, and strategist with nearly 20 years of experience developing biologics. With experience at large and small biotech companies and most recently a leading contract development and manufacturing organization, Gabrielson is now focused on accelerating biosimilar adoption across the industry.

 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, industry experts give an overview of the biosimilars market and discuss factors affecting not only their manufacture, but their upstake in the market as well.

Drug Solutions Podcast: The Biosimilars Landscape

The trend toward digital transformation in biopharmaceutical manufacturing continues as advanced technologies enter the scene and work their way through to manufacturing operations. With the availability of technologies to take automated biomanufacturing from preclinical to commercial-scale, the industry may start to see a wave of changeovers from manual processes to an automated, digital environment. This episode of the 

Podcast will discuss the realities of switching over from manual to digital, and what to expect.

Ajit Yeole, senior director, Life Sciences Manufacturing, Cognizant

Ajit Yeole is the senior director for Life Sciences Manufacturing at Cognizant, based in London, UK.He is responsible for strategy, smart manufacturing, developing new service offerings, and digital accelerators targeted towards addressing the industry needs. Has been closely working on engagements around manufacturing and quality involving emerging technologies (Industrial IoT, advanced analytics, AR/VR , and others) using agile and design-thinking-led approaches. He has led the manufacturing operations management practice for Cognizant in Europe and has delivered large manufacturing programs while collaboratively building tools and templates for consulting offerings. Previously, he worked in manufacturing operations management, IoT (M2M) and OT/ industrial automation as a consultant, solutions architect, and business unit head.

Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte

Laks Pernenkil, PhD, is a principal in Deloitte’s Life Sciences Product, Supply, Manufacturing and Quality Operations practice based in McLean, Va. He has more than 15 years of consulting and technical operations experience in pharmaceutical, biologics and medical device sectors. At Deloitte, his experience includes smart/digital manufacturing and plant floor operations, plant engineering, facilities management, material sourcing, distribution, performance improvement, operational excellence, and market entry operations strategy.

In this episode of the Drug Solutions Podcast, industry experts discuss the challenges and advantages of the digitalization trend in the biopharma industry, with particular emphasis on the impacts to biomanufacturing.

Drug Solutions Podcast: Digital Transformation in the Biopharma Industry

Quality will forever be a topic of discussion for the pharmaceutical industry, and who better to share their insight than FDA? Director of FDA’s Office of Pharmaceutical Quality, Michael Kopcha,deputy director of science, Sau Lee, anddeputy director of operations, Cindy Buhse, join Chris Spivey, editorial director, for a discussion about:

The framework for regulatory advanced manufacturing evaluation (FRAME)

Quality as a co-dependent variable of economic outcome

Advanced versus traditional manufacturing

Pandemic pressures and improved communication

Keeping up with biotech and emerging therapies

Re-shoring drug manufacturing to the United States

What manufacturers need to understand about advancing pharmaceutical science


, PhD, R.Ph., is the director of FDA’s Office of Pharmaceutical Quality (OPQ). This office has more than 1,300 staff responsible for assuring the availability of quality medicines for the American public through assessment, inspection, surveillance, research, and policy. OPQ contributes to the assessment of nearly every type of human drug marketing application including new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), including 351(k) applications (i.e., biosimilars). OPQ also performs the quality assessment of investigational new drug applications (INDs) and establishes quality standards for over-the-counter drug products and facilities. Dr. Kopcha earned his doctorate and master’s degrees in pharmaceutical science and a bachelor’s degree in pharmacy from Rutgers University. He served as an adjunct assistant professor in the Department of Pharmaceutics at Ernest Mario School of Pharmacy at Rutgers.

, PhD, is the deputy super office director of science in the Office of Pharmaceutical Quality. He directs the activities of staff members in OPQ sub-offices responsible for the quality assessment of regulatory submissions (OBP, OLDP, ONDP, and OPMA). He represents OPQ in programs and activities that impact quality assessments by coordinating with OPQ, the Center of Drug Evaluation and Research (CDER), and ORA. He also serves as the point person for the pharmaceutical industry and scientific/academic groups in developing programs to support science- and risk-based application assessment and approval. Prior to joining FDA, Dr. Lee received a bachelor of science degree in chemical engineering from the University of Virginia with a minor in materials science and a PhD in chemical engineering from Princeton University.

is currently the acting senior advisor for scientific operations in the OPQ in the CDER in the FDA. Dr. Buhse joined FDA in 2001 in OPQ’s office of testing and research. She was the director of the office of testing and research from 2013 to 2017 and the director for the office of quality surveillance (OQS) from 2017 to 2019. Before joining FDA, Dr. Buhse worked in management positions in production, validation, and analytical services at Sigma Aldrich Corporation and as a senior research scientist for Rohm and Haas Company. Dr. Buhse received a B.A. in chemistry from Grinnell College and a PhD in physical chemistry from the University of California, Berkeley. OQS assures that quality medicines are available through signal detection, data analysis, review of the state of quality, and proactive stakeholder engagement.

In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, interviews Michael Kopcha, Sau Lee, and Cindy Buhse of FDA about not being afraid to try new approaches and how they invite fresh ideas and abundant communication.

Drug Solutions Podcast: FDA Weighs in on Advancing the Science of Pharmaceutical Manufacturing

Counterfeit pharmaceutical products are a global issue that impacts all stakeholders in the pharma industry and poses a potentially lethal threat to patients. Globally, measures have been put in place to help tackle the problems posed by counterfeit medicines; however, as the United Kingdom is now no longer a part of the European Union, concerns have been raised that the country could be left exposed to an increased prevalence of counterfeit medicines infiltrating the market.

Anti-counterfeiting measures are expected to become stricter in the future to ensure patients are protected and with the rising levels of data that will be required to be managed and processed, blockchain could offer a suitable solution to industry. To learn more about the issue of counterfeit medicines and the potential benefits that can be gained from using blockchain as an infrastructure technology, 

 spoke with Raja Sharif, CEO and founder of FarmaTrust—a provider of blockchain and artificial intelligence (AI) provenance systems for the pharmaceutical and healthcare sectors.

Pharmaceutical Technology discussed the potential increased risk of counterfeit medicines in the UK post-Brexit and how blockchain could be a useful tool to tackle the issue.

Tackling Counterfeit Medicines

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance

William Wainwright, business development manager at Iwata Label USA, discusses the practical security benefits of functional labels at INTERPHEX 2025.

INTERPHEX 2025: How Functional Labeling Can Protect Parentals in Vials and Syringes

The Omni ASCENT, officially launched at INTERPHEX 2025, is a next-generation off-site manufactured vertical utility solution aimed at optimizing the flexibility and efficiency of cleanrooms.

AES Clean Technology Introduces OSM Cleanroom Utility Solution at INTERPHEX 2025

Sherwin-Williams’ advanced coating systems are designed to ensure safety, sterility, and efficiency in pharma manufacturing environments. 

Sherwin-Williams to Showcase Next-Gen Coatings for Pharma Cleanrooms at INTERPHEX 2025

Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.  

Design Quality in Pharmaceutical Design: A Primer for Facility Executives

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.

Videos

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.

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.

Latest Conference

Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment in line with current regulatory requirements at CPHI Milan. 

CPHI Milan 2024: Evolution of Aseptic Processing Equipment for Regulatory Compliance

 sat down with Zaim Gashi, area sales manager, Steriline, to discuss current aseptic processing regulatory requirements and the evolution of aseptic processing equipment to stay compliant. Gashi, who joined Steriline in 2007, has held his current position since 2015. From 1992 to 2015, he built his expertise as a designer and developer of control systems, primarily within the pharmaceutical industry. This technical expertise provided a strong foundation for his current role, in which he manages agents and clients across Southeast Asia, West Balkans, Greece, and Bulgaria. 

“[A]septic processing equipment has evolved following generational technological and regulatory changes and [the] development of new drugs and consumables,” Gashi stated. Evolution of aseptic processing equipment has gone “from very simple equipment with almost an existing flexibility in the past, where the biggest responsibility was on the operators, [to] [t]oday, [where] we have the most sophisticated machines equipped with artificial intelligence technology, including robots with high flexibility,” he explained. Certain operational achievements that were once within the purview of manual operators are nowadays executed by robots or devices that are manufactured using high-precision components.

“In my opinion, the driving force is the ultimate goal of fulfilling the very strict rules imposed by current regulations. We must always bear in mind that we are mostly dealing with products that are injected into human or animal bodies. Therefore, it is of paramount importance to maintain septic conditions during the entire filling and finishing process. In this context, we cannot fail to mention Annex 1 of Volume 4 of the EU [European Union] guidelines, which has become something of a holy book for professional environmental monitoring. Reducing the risk of contamination caused by operators [is among] the important [considerations],” Gashi added.

Gashi also pointed out that, though the vast majority of Steriline’s customers choose isolators as their barrier system, isolators are not mandatory, according to Annex 1; however, isolators are mentioned almost 50 times. “Robotic systems are also mentioned, and [they] are likely to play the main role in environmental monitoring and gloveless isolators. The other driving forces are new drugs and consumables, especially single-use systems and RTU [ready-to-use] containers … [these] are mostly used in case of small batches,” Gashi said.

Attendees can visit Steriline at Booth A42 in Hall 18. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.

CPhI News

Andrew Lewis, PhD, Chief Scientific Officer, Quotient Sciences, discussed the CMC challenges with GLP-1 and oral peptides during CPHI Milan.

CPHI Milan 2024: Navigating CMC Challenges for GLP-1 and Oral Peptides

During CPHI Milan, Andrew Lewis, PhD, chief scientific officer at Quotient Sciences, sat with 

 to discuss the chemistry, manufacturing, and control (CMC) challenges encountered during the development of glucagon-like peptide 1 (GLP-1) and oral peptides.

Lewis noted that a poor correlation seems to exist between the performance of oral peptides in preclinical animal studies and humans. “So, the approach we've pioneered at Quotient is to really tightly integrate our drug product manufacturing and clinical testing … by tightly integrating them, not only does it mean that we can rapidly advance [oral peptide products] into the clinic, but it also enables us, through the use of adaptive CMC clinical strategies, to modify formulations in response to emerging clinical data,” he stated.

Lewis also said that GLP-1s present tolerability challenges, and that this is true of this class of drugs as a whole. Permeability challenges can be addressed by the use of permeation-enhancing technology combined with modified release formulations, which may also enhance control of the pharmacokinetic profile and, hopefully, manage adverse events. “I think it's probably worth pointing out as well that, for oral peptides, they are particularly [used] with permeation enhancers. They are specific. They're very different formulations [from] a standard tablet formulation. You typically will require quite large amounts of permeation enhancers, so they make up a significant percentage of the formulation,” he explained. “Many of these permeation enhancers are quite waxy, [while] some of them are [somewhat] semi-solids.” These characteristics make permeation enhancers generally poorly compressible. In addition, they exhibit poor flow, which can make tableting or granulation difficult.

“There [are] certainly specific formulation and manufacturing processability challenges with oral peptides,” Lewis said. “Peptides behave very differently to small molecular weight drugs.”

You can visit Quotient Sciences at Booth A90 in Hall 7. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.

The management and analysis of vast data generated by advanced analytical technologies are revolutionizing the drug discovery and development process.

Drug Digest: The Rush for Quality Data and the Means to Protect It

In this episode of Drug Digest, industry experts discuss why data is the biopharma industry’s most valuable asset today. The discussion also delves into the means by which the industry as a whole is learning to upgrade data integrity practices to better protect their data and the use of innovative technologies, such as advanced graph technologies, to better shape the drug discovery and development process.

Nathalie Batoux, Product Manager, Research Innovation, IDBS

Nathalie Batoux left the lab and joined IDBS in 2005, driven by her passion to help scientists with workflows and informatics tools to expedite their research. At IDBS, Batoux is a product manager for Research and Innovation. In her role, she regularly interacts with customers and researchers to gain an understanding of their data management needs and drives the development of platform capabilities to provide a solution. Batoux is an organic chemist by training and started her career as a post-doctoral researcher in chemistry working in the domain of nucleoside and dinucleotide analogues.

Thierry Dorval, Head of Data Science & Data Management, Servier

Thierry Dorval received a PhD in image analysis and artificial intelligence (AI) from University Pierre & Marie Curie and then joined the institut Pasteur Korea in 2005 as a group leader specializing in high content screening applied to cellular differentiation and toxicity prediction. In 2012, he joined AstraZeneca, where he focused on developing and advising on quantitative image and data analysis solutions in support of high content phenotypic screening. In 2015 he joined Servier, France, to lead the Data Sciences & Data Management pole of activities where he is in charge of optimizing the early stages of the drug discovery process by taking advantage of cutting-edge computational approaches. This includes usage of AI, knowledge graph database, system modeling and sequences design applied to multiple modalities including small molecules, antibodies, and oligonucleotides.

Jeremy Grignard, Data & Research Scientist, Servier

Jeremy Grignard holds a PhD in computer science, data, and artificial intelligence (AI) from École Polytechnique. He also earned a master’s degree in applied mathematics in Data Science and an engineering degree in computer science and big data. In 2019, he joined the Servier Research & Development Institute to complete his thesis with Inria Saclay, during which he developed computational methods using knowledge graphs, data science, and mathematical modeling to improve early drug discovery. Since 2022, he has been designing and implementing AI projects related to gene inference, explainable machine learning, heteromodality algorithms, biologically constrained deep learning models, knowledge graphs, and large language models.

This discussion explores how the management and analysis of vast data generated by advanced analytical technologies are revolutionizing the drug discovery and development process within the biopharma industry.

Quality Assurance/Quality Control

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