Chronic Disease Priorities, Biomarker Breakthroughs, and CGT-RLT Synergies

Behind the Headlines, Episode 22

ICH Q12 and Post-Approval Changes

The quickly evolving development of biopharmaceuticals is impacting innovation in the industry overall.

Advancements in Biopharma Spur Innovation

What Pharma Manufacturers Need to Know

Every Pharmaceutical Manufacturing Professional Should Know

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Industry Outlook 2025: European Political Impacts on the Supply Chain

The instability in the European geopolitical climate, as well as other areas of the world, has created some nerves in many industries, but the increased focus on the need to have a healthy and safe supply chain for pharmaceuticals is one positive outcome of a tumultuous time, according to Edwin Stone, CEO of Cellular Origins.

“I think for a long time, people took [supply chains] for granted. There was a narrative that has been born over the last 20-plus years that just in time, was the right model,” says Edwin Stone, CEO of Cellular Origins. “And of course, that's very true in a situation where you're putting a box of corn flakes on a shelf, and every extra week that corn flakes packets on the shelf is probably knocking a quarter off of your margin on it. So, by week four, effectively you're giving away for free. That's not so true in medicines. In medicines, we need to take a bigger picture view. We need to look at the accounts differently. I know companies that took very pragmatic views 10 years ago, to set up facilities where they would hold stock of 18-month supply of certain consumables. And it took a lot of warehousing to do it. This was equipment, supply people. But what it meant was, through the construct supply constraints, we saw, for example, through COVID, that they were able to actually continue to supply where others couldn't. The rationale, actually, the shelf space of these high-value consumables was a fraction compared with the value when they sold them to the customer. So, I think what's been really good is [the instability] has caused that focus on supply chain. I think it's managed to remove some of the assumptions of certainty and some of the lack of risk consideration that we'd got into.”

Click the video above to watch the full interview.

Videos

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how geopolitical instability in Europe, and beyond, has impacted the bio/pharmaceutical supply chain.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

FDA Director Martin Makary announced on May 6, 2025 that he has appointed Dr. Vinay Prasad, MD, MPH as the director of FDA’s Center for Biologics Evaluation and Research. Prasad is a hematologist-oncologist and was previously a professor in the department of Epidemiology and Biostatistics at the University of California San Francisco (UCSF).

In a post on X, FDA Director Martin Makary stated (1), “I’m proud to welcome Dr. Vinay Prasad, MD, MPH, as the new head of FDA’s Center for Biologics Evaluation & Research. With 500+ peer-reviewed publications and two books, Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER—a significant step forward. Welcome aboard, Dr. Prasad.”

According to an online biography, Prasad has run the VKPrasad lab at UCSF, “which studies cancer drugs, health policy, clinical trials and better decision making”, hosted an oncology podcast, and has authored more than 500 academic articles. He graduated from the University of Chicago Pritzker School of Medicine, Johns Hopkins Bloomberg School of Public Health, and Michigan State University (2).

According to media reports, Prasad has criticized the response to the COVID-19 epidemic and certain FDA proposals (3, 4). In March 2025, former CBER Director Peter Marks resigned, citing an “assault on scientific truth” and the current administration’s views on vaccines (4).

“Over the past 13 years I have done my best to ensure that we efficiently and effectively applied the best available science to benefit public health,” Marks said in his resignation letter (5). “As you are aware, I was willing to work to address the Secretary's concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine. However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”

https://x.com/DrMakaryFDA/status/1919802781466079264

Sagonowsky, E. FDA Commissioner Marty Makary Taps Vinay Prasad to Head Up CBER. 

https://www.fiercepharma.com/pharma/fda-commissioner-marty-makary-taps-vinay-prasad-head-cber

Lawrence, L.; Mast, J.; and Herper, M. Vinay Prasad Tapped to Run FDA Center that Regulates Vaccines, Gene Therapies. STAT. May 6, 2025.

Marks, P. Letter to Sara Brenner, MD, MPH Acting Commissioner of Food and Drugs U.S. Food and Drug Administration. March 28, 2025. Posted by 

Articles

FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.

New CBER Director Appointed

, is senior manager, Manufacturing Science and Technology (MSAT), at AGC Biologics.

Image Credit: © Alessandro Grandini - stock.adobe.com

Variability in bioburden testing presents a significant challenge in ensuring accurate microbial enumeration during biopharmaceutical manufacturing. This study provides a quantitative framework for understanding and minimizing errors in colony-forming unit (CFU) counts, integrating regulatory guidance with statistical modeling. Through detailed analysis, the author demonstrates how factors such as microbial distribution, dilution steps, and test volume selection contribute to variability, particularly at low CFU levels where Poisson-distributed behavior dominates. Using models grounded in relative error and confidence-based metrics, the author calculates the percentage error associated with replicate counts and test conditions. A root sum of squares approach is further proposed to estimate total combined error from independent sources that include CFU/plate variability, number of replicates, serial dilution, and sample volume. This work offers a statistically rigorous method to enhance microbial detection reliability, thereby supporting consistent quality control and regulatory compliance in biopharmaceutical environments.

Bioburden testing plays a crucial role in ensuring the microbiological quality of biopharmaceutical products by quantifying microbial contamination at various stages of production. Accurate microbial enumeration is essential for compliance with regulatory standards, product safety, and process control. However, numerous factors introduce variability in colony-forming unit (CFU) counts, including microbial distribution, test volume selection, dilution errors, and plating techniques. Understanding the statistical principles that govern these factors is critical to minimizing error and improving the reliability of bioburden testing.

One of the key challenges in microbial enumeration is establishing an acceptable range for CFU counts per plate to ensure accurate results while avoiding errors caused by overcrowding or underrepresentation. Regulatory guidelines such as 

Validation of Microbial Recovery from Pharmaceutical Articles

, and American Society for Testing and Materials (ASTM) standards provide specific CFU ranges to maintain consistency in bioburden assessments. Additionally, sources of variability such as pipetting errors and microbial recovery rates can significantly impact CFU enumeration. Addressing these challenges requires the application of statistical models to quantify errors and establish robust bioburden testing methodologies that enhance data integrity.

1. Breed, R. S.; Dotterrer, W. D. The Number of Colonies Allowable on Satisfactory Agar Plates. 

, 1 (3), 321–331. DOI: 10.1128/jb.1.3.321-331.1916
2. Tomasiewicz, D. M.; Hotchkiss, D. K.; Reinbold, G. W.; Read, R. B., Jr.; Hartman, P. A. The Most Suitable Number of Colonies on Plates for Counting 1. 

, 43 (4), 282–286. DOI: 10.4315/0362-028X-43.4.282
3. USP. General Chapter <1227>. Validation of Microbial Recovery from Pharmaceutical Articles. 

, pg. 3053 (Rockville, Md., 2011).
4. ASTM International. Standard Practice for Determining Microbial Colony Counts from Water Analyzed by Plating Methods. 

 (1998).
5. Maturin, L.: Peeler, J. T. BAM Chapter 3: Aerobic Plate Count. In 

Pharmaceutical Microbiology Manual (ORA.007)

; Revision 2; FDA, 2020.
7. US Forum on Environmental Measurements (FEM) Microbiology Action Team. 

Method Validation of US Environmental Protection Agency Microbiological Methods of Analysis (FEM Document No. 2009-01)

; US Environmental Protection Agency, 2009.
8. Sutton, S. The Environmental Monitoring Program in a GMP Environment. 

, 14 (3), 22–29.
9. Stites, R. Sampling Error and Poisson Processes. 

Naveenganesh Muralidharan, nmural@agcbio.com, is senior manager, Manufacturing Science and Technology (MSAT), at AGC Biologics.

When referring to this article, please cite it as Muralidharan, N. Understanding the Variability in Bioburden Test Results in Biomanufacturing. 

This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.

Understanding the Variability in Bioburden Test Results in Biomanufacturing

n-nitrosodimethylamine molecular structure, 3d model molecule, n-nitrosamines, structural chemical formula view from a microscope | Image Credit: © Сергей Шиманович - stock.adobe.com

In January 2025, FDA posted “Determining Recommended Acceptable Intake Limits for N-nitrosamine Impurities in Pharmaceuticals: Development and Application of the Carcinogenic Potency Categorization Approach” in the Spotlight on CDER Science section of the FDA.gov website (1). The presence of nitrosamines, which are cancer causing chemicals, in pharmaceuticals has been an ongoing concern since 2018 (2).

® asked Amit Chivate, senior market manager, Greater Asia and China, Roquette, to give us his perspective on FDA’s recommendations on how manufacturers should approach nitrosamines.

What can you tell us about the recommendations FDA published in January 2025 for the development and application of the Carcinogenic Potency Categorization Approach (CPCA) to nitrosamines?

The CPCA provides a comprehensive framework for assessing the carcinogenic potential of and acceptable intake limits for N-nitrosamine drug substance-related impurities (NDSRIs) (1). The need for such specific advice stems from the fact that, in contrast to simpler, small-molecule nitrosamines, NDSRIs present complex and unique chemical structures, which make the establishment of accurate acceptable limits (AI) particularly challenging. The CPCA proposes a new protocol that predicts the carcinogenic potency of an NDSRI by analyzing its chemical make-up—whether known or merely theoretical. The first step is a review of available science from animal studies and human epidemiological data to determine the relative risk associated with each nitrosamine compound. Next, scores are awarded according to the structure of α-hydrogen atoms, and the presence of activating or deactivating features are combined to assign the NDSRI to a potency category, which then dictates its acceptable daily intake limit. This approach represents a notable breakthrough because it allows for a precise, risk-based assessment—even in the absence of specific long-term carcinogenicity data for a particular NDSRI–—making it an ideal case study for how regulatory updates can simplify the drug development process.

The CPCA also brings a dose of much needed clarity and transparent scientific process to the field of nitrosamine mitigation, making it a win for consistency, quality and— above all—patient safety.

What makes determining acceptable intake so challenging?

Determining an acceptable daily exposure limit for any given drug impurity is an incredibly complex task—especially in the case of NDSRIs, which are usually unique to each individual drug. Extreme specificity, in this instance, means increased uncertainty, as there is unlikely to be enough tailored safety information on each NDSRI for manufacturers to determine safe exposure levels. As a result, formulators often turn to information gathered on structurally similar compounds or apply a conservative default acceptable intake limit, neither of which yield perfectly accurate results and can force drug companies to make unnecessary changes to their production practices to meet disproportionately strict standards.

Inconsistent regulatory guidelines across different countries, limited long-term epidemiological data, and the difficulty of quantifying cumulative risk from multiple sources all add another layer of complexity. FDA, for instance, sets its AI limits based on safety assessments that evaluate the mutagenic and carcinogenic potential of nitrosamines. Here, it uses rodent carcinogenic potency data or structure-activity relationships (SAR) to identify comparable compounds in the absence of robust data. In contrast, the European Medicines Agency (EMA) predicts carcinogenic potency categories and corresponding AI limits based on the presence of activating or deactivating structural features in the molecule, which influence carcinogenic potency. The recently published CPCA was developed to harmonize and simplify these approaches, with the aim of giving drug manufacturers a simpler, faster and more precise strategy for remaining compliant and protecting patients, without always having to resort to the most extreme safety measures.

NDSRIs are a subset of nitrosamine genotoxic impurities with complex chemical structures that typically mirror that of an API. They form when secondary or tertiary amines in the drug substance or formulation interact with nitrosating agents during manufacturing and storage. NDSRIs are particularly concerning because they are probable human carcinogens, as classified by the International Agency for Research on Cancer. In contrast to simpler, small-molecule nitrosamines, which are more general contaminants that can affect any drug formulation, NDSRIs are formed through the nitrosation of the API in response to specific production or storage conditions. In short, NDSRIs are complex, unique, and, therefore, more difficult to manage.

 What can pharma manufacturers do to manage the nitrosamine risk?

At this point, manufacturers are well versed in nitrosamine risk mitigation, but there are some underreported strategies that we think should be brought into the spotlight. First is the benefit of weaving the compliance process throughout the entire production line, start to finish. Though testing to determine whether drugs meet AI limits is typically carried out on finished products, we advise that all raw materials should first be evaluated for their potential to introduce nitrosamine impurities—either during production or on their way to patients’ medicine cabinets. This initial step can help save time and potential expense through the early identification of contaminated raw materials, as well as speed up the verification process of the final product.

Excipients are another essential, yet often overlooked, element to the nitrosamine compliance conversation. Fillers, binders, disintegrants, and diluents make up as much as 90% of a drug’s overall volume, so it stands to reason they receive at least some of the scrutiny when it comes to product safety (3,4).One of the simplest and most effective safeguarding options for pharma producers is to select excipients with a demonstrated low nitrate content. The drawback with this strategy, however, is that since regulators do not yet mandate their assessment for nitrosamine risk, comprehensive or consistent data on the nitrite content of many excipients can be hard to pin down. This is where the support of an experienced formulation partner can be invaluable, not only for providing drug manufacturers with high-quality information and products, but also with tailored advice on how to optimize production conditions, for safety and productivity.

FDA. Determining Recommended Acceptable Intake Limits for N-nitrosamine Impurities in Pharmaceuticals: Development and Application of the Carcinogenic Potency Categorization Approach. Spotlight on CDER Science. 

https://www.fda.gov/drugs/spotlight-cder-science/determining-recommended-acceptable-intake-limits-n-nitrosamine-impurities-pharmaceuticals

FDA. FDA Statement on the FDA’s Ongoing Investigation into Valsartan and ARB Class Impurities and the Agency’s Steps to Address the Root Causes of the Safety Issues. Press Release. Jan. 25, 2019.

Abrantes, C.G.; Duarte, D.; Reis, C.P. An Overview of Pharmaceutical Excipients: Safe or Not Safe. 

. 2016;105:2019–2026. DOI: 10.1016/j.xphs.2016.03.019

Haywood, A.; Glass, B.D. Pharmaceutical Excipients—Where Do We Begin? 

2011;34:112–114. DOI: 10.18773/austprescr.2011.060

Amit Chivate is senior market manager, Greater Asia and China, at Roquette.

Amit holds an MBA and a PhD in pharmaceutical drug delivery, and has more than 20 years of experience working across R&D, strategy, sales, marketing, and product management in both India and the United States. At Roquette, Amit serves as the senior marketing manager for the APAC region, leveraging his technical and business expertise to drive marketing initiatives and strategic growth.

Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations regarding nitrosamines. 

Strategies for Mitigating Nitrosamine Risk

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

White House | Image Credit: © Zack Frank - stock.adobe.com

United States President Donald Trump has signed an executive order containing several directives to FDA and the Environmental Protection Agency (EPA), aiming to reduce regulatory barriers and restore a robust domestic manufacturing base for prescription drugs (1).

According to a Fact Sheet issued by the White House on May 5, 2025, the order directs FDA to take several steps to reduce the time needed to approve pharmaceutical manufacturing plants located in the US, including eliminating “duplicative and unnecessary” requirements—although, the fact sheet did not clarify what those requirements are—streamlining the review process, and working with domestic manufacturers to offer early support before a facility comes online (1).

Additionally, FDA is being instructed to increase fees for, and inspections of, foreign manufacturing plants, and to improve enforcement of API source reporting by foreign drug producers (1). The administration suggests displaying a public list of those facilities that do not comply.

FDA on May 6 announced an intention to expand unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and certain other products (2).

“For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today,” FDA Commissioner Martin A. Makary, MD, said (2). “This is a key step for FDA as part of a broader strategy to get foreign inspections back on track.”

Regarding the EPA, the Trump Administration is calling for the acceleration of construction of facilities designed to manufacture prescription drugs, APIs, and any other raw materials necessary. The White House said critical gaps exist in the creation of an affordable and resilient domestic pharmaceutical supply chain, and that current estimates of five to 10 years for building new manufacturing capacity are “unacceptable” in terms of national security (1).

Bio/pharmaceutical companies either headquartered in the US or with major operations within the country have been weighing the potential impacts of the Trump Administration’s tariff policies since the 47th president re-took office in January 2025, with an expectation that 

 sooner or later, one way or another (3). Many companies and executives are 

Some companies have been proactive. In February 2025, 

 that it would be building four new domestic manufacturing sites in the United States, saying that the Tax Cuts and Jobs Act, passed in 2017 during the prior Trump Administration, was the impetus for the company’s decision to expand nationally (5).

The May 5 executive order, the fact sheet said, builds on actions taken in Trump’s first term to reshore production of essential medicines and reduce American reliance on foreign drug producers (1).

“We don’t want to be buying our pharmaceuticals from other countries because if we’re in a war, we’re in a problem, we want to be able to make our own,” President Trump said, as quoted in the fact sheet. “As we invest in the future, we will permanently bring our medical supply chains back home. We will produce our medical supplies, pharmaceuticals, and treatments right here in the United States.”

The May 6 FDA action aligns with the sentiments of the fact sheet, which said that the executive order is designed to ensure FDA prioritizes American manufacturing facilities over foreign ones (1).

“This change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies,” FDA’s press release said (2).

Under terms of the May 5 executive order, federal agencies that issue permits for domestic pharmaceutical manufacturing facilities are being directed to designate a single point-of-contact for permit applications with interagency support from the White House Office of Management and Budget to ensure the most efficient process (1).

1. The White House. Fact Sheet: President Donald J. Trump Announces Actions to Reduce Regulatory Barriers to Domestic Pharmaceutical Manufacturing. 

, May 7, 2025.
2. FDA. FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities. Press Release. May 6, 2025.
3. Bigica, A. 

Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact.

Tariff Pause Reinforces Uncertainty Among Biopharma Professionals.

, April 10, 2025.
5. Eli Lilly and Company. Lilly Plans to More Than Double US Manufacturing Investment Since 2020 Exceeding $50 Billion. Press Release. Feb. 26, 2025.

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.

Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing

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Intertek has announced an expansion of its good manufacturing practice (GMP) pharmaceutical services laboratory in Melbourn, United Kingdom, adding 6000 square feet of purpose-built laboratory and office space to bring the site’s total footprint to 46,000 square feet (1).

In a press release on May 7, 2025, the company said the expansion of the Melbourn facility—which for more than 30 years has specialized in analytical, formulation, and clinical manufacturing services for inhaled and nasal drug products—is a response to the globally rising demand from clients for inhaled biologics (1). Such routes of administration are effective in delivering biologics as well as messenger RNA (mRNA), nucleotide-based therapeutics, and vaccines that treat respiratory diseases.

“This GMP lab expansion significantly enhances Intertek’s testing and analytical capabilities, enabling our clients developing novel inhaled biologics to accelerate their drug development timelines and ensure the highest standards of quality and efficacy in their products,” Ross McCluskey, Intertek executive vice president, EMEA and Government and Trade Services, said in the release (1).

While inhaled or nasal routes allow for targeted delivery to the lungs along with the potential of reducing the amount of active ingredient needed, ensuring product performance and manufacturability, as well as clearing regulatory and commercialization hurdles, have been challenges for developers, according to Intertek (1).

"Our growing facility underscores our dedication to supporting innovation and the continuous development of safe and effective inhaled biologics,” Ashleigh Wake, Intertek pharmaceutical services director for UK and Switzerland, said in the release (1). “In partnership with our clients, we are helping to advance innovations in critical medicines that will reach patients in need worldwide."

Some of the planned features of the expanded Melbourn laboratory are advanced mass spectrometry (MS) instrumentation, including high-resolution MS, and a particle characterization laboratory able to support development of both small- and large-molecule inhaled and nasal drugs (1). Capabilities characteristic of Intertek’s Manchester, UK laboratory, such as cell-based potency assays that call for the handling of hazardous biological materials and viral analytical work, will be reflected in the Melbourn site’s new bioassay and cell culture units.

Prior to announcing this facility expansion, Intertek in December 2024 

 with UK-based CrystecPharma, a crystal and particle engineering company that applies proprietary modified supercritical fluid technologies to improve drug performance, aiming to advance formulation science and accelerate development timelines for inhaled medicines, particularly dry powder inhaler products (2).

Intertek is the host of the inhaled and nasal drug product sector’s first dedicated forum for such types of biologics and will be holding its fourth annual 

, in Cambridge, UK, on Sept. 25–26, 2025 (1,3).

1. Intertek. Intertek Expands Pharmaceutical Services Laboratory to Enhance Capabilities in Inhaled Biologics and Accelerate Drug Development. Press Release. May 7, 2025.
2. Intertek. Intertek Partners with CrystecPharma to Advance Formulation Science and Accelerate Development Timelines for Dry Powder Inhaler Products. Press Release. Dec. 11, 2024.
3. Intertek. Inhaled & Nasal Biologics | DNA Forum 2025. 

The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.

Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space

AAPS National Biotechnology Conference 2025: High-Concentration Biologics

Biologic drugs typically have a higher dosage than small-molecule drugs, according to Lun Xin, associate director at WuXi Biologics, and sometimes patients will need to spend hours at an infusion center to receive these treatments. “That's a growing experience for a lot of people, especially folks that [are] dealing with things like cancer or long-term arthritis disease or something of that nature, which is lot of time … So, there's a good amount of need for a patient to take [the drug] home and then be able to use pre-filled syringes or autoinjector cartridges, where they can deliver the dose by themselves in the comfort of their home,” says Xin. “Now the limitation with that is you can only put in so much drug into the subcutaneous space using a prefilled syringe or auto injector. And a lot of that's believed to be about two milliliters to be a good benchmark. So now that you have the ideas, and you have to deliver several 100 milligrams of those into a two milligram, two milliliters of volume, right? So, there's a need to develop the concentration of the protein therapeutics to several 100 milligram per mL.”

 spoke with Xin about these challenges associated with the formulation of high-concentration biologics ahead of his presentation at the AAPS National Biotechnology Conference, which is being held May 4–7, 2025 in Boston. Xin’s presentation, “Accelerating High Concentration Formulation Development with Big Data-Driven High-Throughput Technologies”, occurred on Tuesday, May 6 .

Click the video above to watch part one of our interview with Lun Xin.

Lun Xin is associate director at Wuxi Biologics.

BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about high-concentration biologics and some of the biggest challenges associated with their formulation.

Industry Outlook 2025: The Future of Technology in the Biopharma Industry

Technologies such as artificial intelligence (AI) and machine learning (ML) are advancing quickly in many industries, including the biopharmaceutical industry. One challenge in the implementation of these technologies in biopharma, according to Edwin Stone, CEO of Cellular Origins, is the data sets and the sensitivity surrounding it.

“There's a huge amount of proprietary data,” Stone says. “And so, I think [this is] something actually, as an industry, we're really going to have to think about a lot harder than we had previously. And remembering here, we're in an industry where, by solving these problems, we help make people better. How do we collaborate better? How do we understand and separate out the competitive landscape from our ability to make enormous strides for us? And I think [it] will be a massive shame for the industry if we all operate in our silos and we miss out on the benefit that I think a lot of those data processing technologies could have. I think the other piece, of course, with this is AI and ML are having a huge impact on [drug] discovery, and I think in the world, in the virtual world, in the software world, that's unsurprisingly, where they found their home.”

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how technological advances will impact the biopharma industry in the future.


AAPS National Biotechnology Conference 2025: AAV Vector Production

Adeno-associated virus (AAV) vectors are commonly used for gene therapies, according to Noah Kopcho, field application scientist at Gyros Protein Technologies. AAV vectors come with challenges in productions, however. “Namely, compared to other vectors, AAV often has lower titers,” says Kopcho. “This can present problems with scalability. During the production and purification workflow, there are several different contaminants that need to be kept in mind, and purity is often essential. And at the at the end of the workflow, you know all of these measurements that need to be made can present several different bottlenecks that that can be very time consuming and can often eat into efficiency.”

 sat down with Kopcho to find out how these challenges can be overcome. Click the video above to watch the interview.

Kopcho’s spoke on this topic at the AAPS National Biotechnology Conference 2025, which is happening May 4–7, 2025 in Boston. His presentation, “

Accelerate Development of AAV-based Gene Therapies with Automated Viral Vector Titer and Impurity Analysis

Noah Kopcho is field application scientist at Gyros Protein Technologies.

BioPharm International® sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about the challenges in the production of AAV vectors.

Rishi Pimentel, gChem, talks about the company's rebrand, and how it aligns with green chemistry, innovation, and regulatory excellence

Gaylord Chemical is Now gChem

gChem is positioned as a global leader in pharmaceutical excipients and drug delivery solutions. As a key partner for formulators and manufacturers, gChem is committed to providing sustainable, high-performance excipients that enhance drug solubility, stability, and bioavailability. In this interview, Rishi Pimentel, Global Business Development Director of Life Sciences at gChem, talks about Procipient®, an innovative and powerful solvent designed for drugs with low water solubility in the injectable drug delivery space. He also covers the benefits of gChem being a global company based in the U.S., as it allows the company to work closely with partners and formulators around the world.

How gChem (formerly Gaylord Chemicals) is embracing its rebrand that aligns with green chemistry, innovation, and regulatory excellence

Featured Content

Behind the Headlines, Episode 22

ICH Q12 and Post-Approval Changes

Advancements in Biopharma Spur Innovation

What Pharma Manufacturers Need to Know

Every Pharmaceutical Manufacturing Professional Should Know