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Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

Ask the Expert

Outsourcing Partnerships Fuel Global Biopharma Discovery and Scale-Up

Drug Digest February 2026 

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

David Schoneker is president, Black Diamond Regulatory Consulting, LLC

A Risk-Based Framework for Excipient Development

 spoke with David Schoneker, president, Black Diamond Regulatory Consulting about what goes into the development of a new and/or novel excipient. In part 4 of this series, Schoneker previews a workshop at Excipient World 2026 that will present concepts from a risk-based framework for excipient development, including a draft guideline being created by IPEC-Americas.

“It's an interesting workshop that we're going to have because there are many different types of risks that have to be assessed in bringing forward a new excipient product,” explains Schoneker. “And there's the safety and the quality risks that everybody talks about a lot, but there's also significant cost and market acceptance risk that have to be evaluated to determine whether to bring forward a new excipient. Many times, excipient companies will have a really great and interesting product that could solve a lot of problems, but when they look at the market and acceptance risk, it's just not worth it to them to fund the studies or whatever it might be.”

“Most new excipient products don't have a lot of risk. They don't have a significant need for a whole lot of safety data,” says Schoneker. “In many cases, there is no need for any additional safety information. There's just a matter of maybe pulling it together into a dialogue or a story about why it's safe in this type of application. Because of that confusion, what we have found at IPEC, is every time we ever talk about new excipients, everybody jumps to novel excipients.”

A committee within IPEC-Americas has drafted decision trees for excipients, such as those for higher level of use, new route of administration, new population, pre-mixed, co-processed, and novel products, to determine if they meet certain criteria. The decision trees will be presented at the workshop with the intention of getting feedback from industry, suppliers, and distributors.

“The goal is after Excipient World, after we get this broad feedback from all of industry and regulators and everybody who will be there, we'll then refine the decision trees a little bit, and then our committee will start taking forward and putting text around those decision trees to figure out what are the details about how to do that, those different feasibility analysis pieces, assuming to bring these products forward.”

Watch the interview above to learn more about what goes into the development of a new excipient. Dave will be participating in the workshop, “Risk Based Framework for Development of New Excipient Products”, at 

 being held in Nashville from May 4-6, 2026.

Raghuram M, Sheehan C, Filler R, Schoneker D, Liu J, Gronewold C. Risk Based Framework for Development of New Excipient Products and USP’s Novel Excipient Emerging Standards Approach to Meet Stakeholder Needs. Presentation at Excipient World Conference & Expo 2026. May 4, 2026. 

https://s6.goeshow.com/ipec/annual/2026/conference_program_sessions.cfm?session_key=B7748D16-9EBD-188A-D5EE-3FF177ECEAC0&session_date=Monday,%20May%2004,%202026

Videos

In part 4 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, gives a preview of the workshop, Risk Based Framework for Development of New Excipient Products, at Excipient World 2026. 

Maria Batalha is part of the Consultancy Services in Product Life Cycle Management at ValGenesis as a Data Science Specialist. She joined ValGenesis in 2021 and was involved in the design of digital solutions for industry 4.0 that included advanced MVDA techniques, prototyping activities with R and Shiny framework and machine learning modelling in python. As part of ValGenesis Consulting Services team, Maria has focused her work into the Continued Process Verification framework and implementation, tech transfer activities and process intensification. Maria has a master's in Bioengineering by Universidade Técnica de Lisboa, a Post Graduation in Enterprise Data Science and Analytics by Universidade NOVA IMS Lisboa and 6 years of experience in industry projects mainly in the field of medical devices and consultancy

Maria Batalha, Valgenesis discusses how a centralized digital platform unified drug substance data from R&D to commercial manufacturing, enabling smarter, FAIR-compliant pharma operations.

Maria Batalha on How Digital Tools Transform Drug Substance Lifecycle Management

Access Part 1 of this interview on how Batalha’s team assited a comapny in centralizing drug substance data, standardize processes, and unlock powerful AI-driven insights.

, Maria Batalha, senior project lead, Delivery, Valgenesis, discusses a real-world case study in pharmaceutical digital transformation, examining how a centralized digital platform can manage the full lifecycle of a drug substance, from early R&D through to commercial manufacturing, in alignment with Industry 4.0 principles. Batalha’s team unified disparate sets of legacy data across multiple mediums into a single, FAIR-compliant repository, making critical process knowledge findable, accessible, interoperable, and reusable across all three stages of a product's lifecycle. The session highlights how AI-enabled analytics and visualization tools can surface hidden patterns and support data-driven decision-making.

Batalha reflects on how the digital platform showcased in the presentation was applied to a genuine product journey spanning research and development through to commercial manufacturing. The case study draws on actual data from each phase of that product's lifecycle, illustrating how the platform serves as more than a theoretical tool.

Batalha explains that the specific project involved a client already operating commercially in other markets who was working toward FDA approval to enter the US. "We could log in the platform data from the R&D, data from stage two validation, and then data from commercial manufacturing already," she notes, underscoring how the solution brought together previously fragmented information into one cohesive system.

A key theme of the conversation is the platform's versatility. Batalha emphasizes that its application extends well beyond the single case study presented, spanning drug substances, drug products, analytical method monitoring, and even medical devices.

"Our platform gives you the flexibility of building your project there," she explains, pointing to how different product types, from small molecules to highly complex biologics and cell and gene therapies, can be accommodated within the same framework.

When asked about handling more complex modalities, Batalha is clear that the underlying approach remains consistent regardless of complexity. The system simply scales to accommodate more variables, more configurations, and more monitoring parameters. Whether a team is working with a straightforward small molecule or a multi-parameter biologic, the platform adapts without requiring a fundamentally different methodology, making it a flexible, future-ready solution for organizations at any stage of their manufacturing journey.

Maria Batalha, Valgenesis, discusses how a centralized digital platform unified drug substance data from R&D to commercial manufacturing, enabling smarter, FAIR-compliant pharma operations.

 Maria Batalha on How Digital Tools Transform Drug Substance Lifecycle Management

Ryan Kelly is the Interim Chief Executive Officer and Senior Director of Supply Chain Security & Brand Protection at Rx-360, an international, member-driven pharmaceutical supply chain consortium focused on patient safety, quality, and supply chain integrity. In this role, he leads cross-industry initiatives spanning joint audits, supply chain security, and quality oversight, and works closely with regulators, manufacturers, suppliers, and logistics partners to strengthen risk management across global supply networks.

Ryan Kelly, Rx360, shares expert strategies for mapping, auditing, and protecting pharmaceutical supply chains to ensure global patient safety.

Ryan Kelly's Tips for Drug Supply Chain Protection

how third-party audits and integrated quality-supply chain strategies protect pharma supply chains and patient safety.

, Ryan Kelly, interim CEO and senior director of Supply Chain Security and Brand Protection, Rx360, discusses how pharmaceutical organizations can better protect their supply chains and, ultimately, ensure patient safety.

Kelly narrows in on this piece of advice: know where your product is at every stage of its journey. As Kelly puts it, "Make sure you understand every single product and its entire end-to-end flow."

This means tracking inventory from raw materials and APIs through in-process manufacturing, packaging, final labeling, and delivery to the customer. Kelly notes that many organizations lack full visibility into where their physical product actually resides at any given moment.

Beyond mapping, Kelly emphasizes the importance of rigorous auditing. Companies should evaluate their suppliers and service providers not only against expected practices, but against every possible risk within those partners' operations. Digitizing this process, he adds, makes the effort significantly more effective.

Kelly also speaks on how Rx360 synthesizes standards from the FDA, Health Canada, and other global regulatory bodies into a unified framework covering good manufacturing, distribution, and clinical practices. Rather than defaulting to the lowest common regulatory denominator.

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Scientist comparing two vials in laboratory research setting | Image Credit: ©Phimwilai -stock.adobe.com


Despite the inherent variability of recombinant proteins and antibodies, biosimilars must be comparable to their corresponding branded counterparts with respect to safety, efficacy, and pharmacokinetic and stability profiles.

 Trends in the sector, including an increasing focus on patient centricity, such as in the form of citrate-free buffer systems, and the move to high-concentration formulations that allow subcutaneous (SC) administration, present growing challenges for biosimilar formulators as they seek to demonstrate comparability through analytical and functional characterization, particularly in the face of complex intellectual property issues.

What Are the Main Biosimilar Formulation Development Challenges?

Biosimilar formulation development requires navigating around scientific, regulatory, and legal challenges, according to Sung Keun Chang, drug product team leader for Samsung Bioepis. One of the main challenges he highlights is the thicket of patents for reference products that are designed to extend patent protection.

Such patents not only include the core molecule, but also excipients or a class of excipients in the drug formulation, manufacturing processes, and delivery devices, Chang notes. “Due to such protection, buffers, stabilizers, or surfactants that are included in biosimilar formulations need to be re-optimized or replaced with alternatives. In extreme cases, excipients such as buffers cannot be utilized at all if there is patent protection for the class of excipients,” he says.

The industry shift toward high-concentration protein formulations (HCPF) primarily designed to enhance patient convenience through SC delivery is making biosimilar formulation optimization even more difficult. Maintaining the stability of high-concentration formulations and managing their higher viscosities during manufacturing and administration can be challenging.

“A key issue is the constraints placed on formulators of SC formulations by proprietary-based excipient systems, which creates bottlenecks to demonstrated comparability with reference products,” observes Venkat Reddy Sunkara, global head of Regulatory CMC at ICON.

Recent regulatory trends around waiving comparative efficacy studies (CES) in biosimilar development do provide additional opportunities to develop biosimilars. However, with analytical comparability replacing clinical proof of efficacy because biologic products are process-defined, not composition-defined, it is even more essential to define uncertainties analytically in a manner that is aligned with regulatory requirements, according to Kimberly Salgado, head of ICON’s Center for Biosimilar Drug Development. Chang agrees that the new regulatory flexibility poses challenges to biosimilar formulators with respect to meeting the rigorous, comprehensive requirements for analytical characterization. Demonstrating comparability of post-translational modifications can be particularly challenging.

What Are the Implications for Biosimilar Commercialization?

Surmounting these scientific, regulatory, and legal hurdles is a prerequisite for approval and commercialization of a biosimilar product. “In many cases, formulation-related patents can evolve into a family of patents that minimize the possible design space for biosimilar formulations during the life cycle of the product. As a result, biosimilar companies need to navigate around a moving and evolving target when developing biosimilar formulations,” Chang comments.

In addition, for biosimilars being designed for improve patient convenience (eg, SC delivery), it is necessary to demonstrate not only therapeutic equivalency, but improved performance attributes, such as lower local irritation and better tolerability, according to Salgado.

How Can Biosimilar Developers Demonstrate Analytical Comparability?

The first step, says Salgado, is to identify tiered, risk-based critical quality attributes (CQAs) that are likely to impact clinical safety and efficacy and link them to the product mechanism of action (MoA) and clinical relevance.

Equally important is the need to account for the inherent lot-to-lot variability of reference products and regional sourcing differences using high-resolution sensitive techniques that can detect subtle differences, according to Sunkara.

Demonstrating analytical similarity is, therefore, often achieved by analyzing a large number of batches of the reference product over an extended period of time to determine the acceptable variability range for the biosimilar product, Chang observes. “Using an insufficient sample size may result in a similarity range that is too narrow to be met,” he adds.

Finally, both Sunkara and Chang emphasize the importance of using orthogonal analytical methods that are complementary and based on different scientific principles to ensure that target CQAs are robustly met.

Overcoming Challenges in High-Concentration Formulations

High-concentration formulations can pose multiple challenges, Chang observes, including an increased propensity for aggregation and particle formation due to dense protein concentrations, as well as difficulties in manufacturing and drug delivery because of higher viscosities.

In addition, Sunkara notes that most of these formulations use proprietary excipient systems for which establishing analytical comparability can be difficult.

Some of these challenges can be overcome through optimization of pH, ionic strength, or the excipients during formulation development, according to Chang. Indeed, using innovative excipients may be necessary to achieve stable formulations that can be administered using “patient-friendly” delivery mechanisms.

“For example, altering the pH away from the isoelectric point can reduce electrostatic-driven interaction,” Chang comments. “Certain amino acids can also effectively mask the hydrophobic patches on protein surfaces, thereby preventing protein-to-protein interaction. In addition, viscosity can be further controlled by minimizing or avoiding the use of certain stabilizers that increase viscosity, or by adding excipients that disrupt self-association,” he says.

Biosimilar formulations must also meet product shelf-life expectations and support device functionality, and properties such as syringeability, injector performance, and patient usability must also be considered, says Salgado. The latter issues can be managed by fine-tuning formulations for pH, osmolality, and using advanced filtration techniques to reduce particle seeding. Container closure systems must also be optimized to ensure minimal silicone oil use.

Underlying all these solutions for overcome challenges to the formulation of high-concentration biosimilars, contends Sunkara, is using advanced characterization techniques to offset any risks.

Are There Best Practices for Overcoming Regulatory Hurdles for More Patient-Friendly Biosimilars?

Biosimilars provide benefits to patients and healthcare systems through affordability, expanded patient access, and innovation. One of their key benefits emphasized by Chang is to enhance usability of the reference product by adding innovative features. He highlights the removal of citrate in biosimilar formulations because it is now known to be a potential cause of injection site pain (ISP) during subcutaneous delivery. Biosimilar developers also often provide a wider choice of drug delivery devices than available for the reference product, such as autoinjectors or other advanced drug delivery devices in addition to existing vials and prefilled syringes.

During formulation development, Sunkara emphasizes following International Council for Harmonisation’s (ICH) Q5E principles for comparability strategies and using orthogonal analytical and functional assays that are relevant to the MoA to mitigate potential risks.

 Equally important, he notes, are conducting device and drug product formulation development in parallel and employing human factors/usability studies to demonstrate dose accuracy, implementing controls for extractables and leachables, and assuring container closure integrity.

Developers of more patient-friendly biosimilar formulations may also need to establish a robust bridging strategy to demonstrate that the improvements do not impact the quality, safety, or efficacy of the product, according to Chang. “As part of the bridging strategy, it is important to build a robust data package along with a comprehensive risk assessment to justify such changes,” he adds. Engaging with regulators early in the development stage to determine whether proposed analytical and clinical bridging strategies will be sufficient for justification is also highly recommended by Chang.

Overcoming Challenges Created by Shrinking Timelines

Biosimilar developers are under intense pressure to shorten development timelines while still meeting ever‑higher regulatory and scientific expectations. “To meet these objectives,” contends Salgado, “it is necessary to adopt a combination of scientific, regulatory, operational, and strategic solutions to compress timelines without compromising approvability or commercial viability.”

Examples highlighted by Salgado include the following:

early and iterative regulatory engagement to avoid rework triggered by post‑submission questions

platform-based approaches to process and analytical method development that are backed by accumulated knowledge

parallelization of chemistry, manufacturing, and controls (CMC), nonclinical, and clinical activities

leveraging advanced analytics to de-risk clinical programs

ensuring access to ready-to-use manufacturing capacities/capabilities.

Formulation development can also be accelerated using high-throughput screening technologies that enable parallel testing of a wide range of buffers, stabilizers, and surfactants in a short timeframe, adds Chang. He also points to the use of automated equipment for sample preparation and analytical testing as a means for further shortening development timelines.

All of these efforts must be pursued while maintaining compliance with regulatory expectations. Salgado notes that biosimilar developers should focus on the totality of evidence of similarity generated from their analytical data, followed by a more abbreviated clinical trial for confirmation of this similarity if needed. She adds that using final formulations in pharmacokinetic similarity studies can reduce risk and ensure stronger demonstration of comparability, which is important because if similarity can be demonstrated through a strong CMC and nonclinical package, CES can potentially be avoided.

Impact of FDA’s Proposed Changes for Demonstrating Biosimilarity

The FDA in October 2025 introduced several proposed changes to its requirements for establishing the comparability of biosimilars to reference products.

 The draft guidance eliminates the need for comparative human clinical studies if biosimilar developers can provide sufficient analytical testing data to demonstrate similarity.

 In a separate initiative, the agency has elected to stop recommending that “switching studies” be conducted to show interchangeability between different biosimilars.

These regulatory updates from the FDA, as well as streamlined pharmacokinetic requirements and the expanded acceptance of non-US-licensed comparator products, are expected to significantly reduce biosimilar development costs by up to 25% while shortening timelines, according to a Celltrion official. “In this evolving environment, biosimilar developers are increasingly focused on enhancing efficiency across the entire development process while maintaining robust analytical comparability and regulatory compliance,” the spokesperson remarks. “These changes are meaningful and are expected to accelerate pipeline expansion, including into small and mid-sized markets that were previously less accessible due to high development costs,” the Celltrion official also contends.

Are There Any Emerging Challenges to Biosimilar Formulation Development?

With innovator companies increasingly launching line extensions (eg, high‑concentration, citrate‑free, device‑enabled, longer shelf life, room‑temperature stable), biosimilar developers often still chase original reference products. However, observes Salgado, “future commercial relevance and clinical acceptance will depend on matching (or at least not falling behind) the latest reference product attributes.” Successful biosimilar developers will need to find a way to eliminate these gaps.

Using novel excipients is one way to do so, but there remains no separate regulatory pathway for approval of such excipients. Consequently, novel excipients are considered high-risk and often are avoided in biosimilar formulations (especially in SC products), particularly where switching/substitution is expected, according to Sunkara. He also notes that regulatory expectations are increasing with respect to particle analysis, with data now typically required on not just particle counts, but particle morphology, composition, and immunological relevance.

Newer technical challenges with increasing relevance for biosimilar developers highlighted by Sunkara include the inability of current screening tools to fully predict non-linear behaviors such as self‑association, shear sensitivity, and viscosity jumps, of high-concentration formulations; the increasing role of autoinjectors and other advanced delivery systems in dictating formulation limits, including maximum viscosities, injection forces, and dwell times; and the rising ability to detect minor formulation‑related differences previously invisible to older, less-sensitive analytical methods.

What Will Matter Most for Future Biosimilar Formulation Development?

Given the current trend in biologics development to more patient-friendly, convenient products, biosimilar developers will need to balance innovative formulation approaches with regulatory compliance, quality assurance, and cost management to ensure commercial success.

 Selecting optimal formulations will require input from cross-functional teams of experts, incorporation of patient-centric formulation innovations, comprehensive characterization and establishment of comparability, and the use of quality-by-design approaches, process analytical technologies, and artificial intelligence tools. This strategy will ensure cost-effective development, product performance (quality, safety, efficacy), regulatory compliance, and avoidance of patent-based legal restrictions.

In this vein, companies such as Celltrion are strengthening competitiveness through integrated capabilities spanning development, manufacturing, and direct sales, while driving formulation innovation that reflects the needs in clinical practice, according to a spokesperson from Celltrion. “The launch of differentiated formulations—such as liquid intravenous and SC options—demonstrates how biosimilar developers can improve patient convenience and operational efficiency in real-world settings,” the Celltrion official concludes.

Bas TG. Innovative formulation strategies for biosimilars: Trends focused on buffer-free systems, safety, regulatory alignment, and intellectual property challenges. 

Leukocare Editorial Team. Biosimilar Formulation Development: Navigating the Delicate Balance. Blog, July 7, 2025. 

https://www.leukocare.com/blog/biosimilar-formulation-development

Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process, 

FDA. FDA moves to accelerate biosimilar development and lower drug costs. Press Release, October 29, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs

Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies

Articles

High-concentration formulations and patient centricity are challenges to the formulation of biosimilars, which already face patent protection barriers.

Overcoming Formulation Challenges for Biosimilars

Excipients and Intended Use

 spoke with David Schoneker, president, Black Diamond Regulatory Consulting about what goes into the development of a new and/or novel excipient. In part 3 of this series, Schoneker emphasizes that excipient manufacturers must balance market expansion with the significant data requirements and liabilities associated with different routes of administration.

New excipients are typically created with a specific target market and intended use in mind—often starting with oral applications to manage the volume of required safety and analytical data.An excipient is utilized for an application outside of this intended scope, such as moving from oral to parenteral delivery, may pose challenges.The supplier may lack the necessary safety data to support the new application or may even refuse to sell the material due to liability concerns.

Schoneker highlights that the decision to develop additional data is often an economic one; the high cost of toxicity studies must be justified by the expected sales volume. This creates a gap where pharmaceutical companies may find that no existing excipient solves a specific formulation hurdle. To bridge this gap, Schoneker advocates for collaborative negotiations. When a drug developer has a critical need for a novel excipient, they may choose to co-fund or fully sponsor the required toxicity studies.

These collaborations frequently involve exclusivity agreements, allowing the drug developer a period of sole access to the technology before the manufacturer expands the market to establish a broader regulatory precedent. Early engagement with suppliers may ensure that the available safety data aligns with the drug’s clinical objectives.

In part 3 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, talks about the collaboration between the pharma company and the excipient supplier when different routes of administration are considered for an ingredient.

PharmTech Weekly Roundup—May 1, 2026

Welcome to PharmTech’s Weekly Roundup. I’m Susan Haigney, lead editor of PharmTech.

Industry themes seen across the industry this week include the continued integration of artificial intelligence and robotics to enhance quality and efficiency, a strengthened focus on sustainability to reduce the carbon footprint of bioprocessing and evolving regulatory pathways that prioritize data trust and international alignment. From novel drug delivery devices to lean construction methodologies, these stories highlight a sector-wide push toward smarter, more resilient operations.

 s the first and only single-inhaler triple maintenance therapy for asthma in the U.S. for patients aged 12 and older. This is the product’s second approved indication since 2020.

The use of virtual control groups instead of animals in drug development was explained by Laura Lotfi of Charles River in the first episode of 

. The new approach method would help to reduce the number of animals used in the development of pharmaceuticals.

David Schoneker of Black Diamond Regulatory Consulting 

 are not approved as standalone substances but are evaluated by the FDA exclusively as part of specific drug product applications in part 2 of a multipart interview.

challenges of visual inspecting prefilled syringes

 were addressed by Daniele Ansaldi, technical manager for Automated Inspection Machines at Antares Vision Group North America, who explained that advanced AI-native vision platforms and specialized handling technologies are now being used to overcome these unique geometric challenges.

coverage of INTERPHEX 2026 continued this week with interviews with experts on topics ranging from sustainability, bioprocessing, and automation.

George Kwiecinski, CEO and co-founder of Global Key Solutions Corp, spoke with 

 about how manufacturers are encouraged to reassess their GMP audit strategies to address rising regulatory scrutiny regarding supplier oversight and the use of AI in documentation.

Leslie Weaver and George Hunt, IPS discussed how

early alignment of lean principles and sustainability goals in pharma construction is critical for reducing costs and absorbing schedule disruptions.

Todd Vaughn and Christa Myers of CRB explained how

implementing robotics in aseptic manufacturing improves repeatability and compliance but requires a shift toward more technically skilled operator roles.

 stressed that the large engineering, procurement, and construction management model is a tool for pharmaceutical capital projects, allowing teams to overlap design and construction phases to compress overall timelines.

adopting point-of-use cell culture media manufacturing

 can reduce the carbon footprint of bioprocessing by approximately two-thirds while providing logistical flexibility.

Successful smart manufacturing adoption depends on establishing foundational data trust and focusing on deep problem definition rather than just technical solutions, according to 

Jason Pennington and Bethany Silva of Endress+Hauser and Mel Radford of Rockwell Automation.

Stuart Tindal of Sartorius and David Chau of Thermo Fisher

 talked about how collaborative industry standards are driving the development of integrated multi-modal sensor models to enhance precision in continuous bioprocessing.

As we look ahead, the ability to balance technical innovation with rigorous regulatory compliance will define the next generation of pharmaceutical excellence. Staying informed on these shifts in construction, manufacturing, and drug development is essential for maintaining a competitive and compliant operation. Thank you for watching.

Virtual control groups, automation, novel excipients, and sustainability are some of the topics covered by PharmTech this week.

Avi has 20 years of industry experience in gene therapy, viral vectors, and vaccines. He is currently the President of SK pharmteco Cell and Gene North America managing the business unit. Previously he worked at Novartis Gene Therapies where he supported a pipeline of 15+ gene therapy products in development from preclinical to Phase III development and led the development and implementation of 4 gene therapy manufacturing processes across 4 CGMP and 3 laboratory sites. Prior to his role at SK pharmteco, Avi was the Chief Technical Officer at the Center for Breakthrough Medicines. His prior positions include Head of Technical Development at Novartis Gene Therapies, Director of Manufacturing Science & Technology at Avexis, Inc., and Product lead at Seqirus. Avi holds an MS in Biology from Adelphi University and an MBA from the University of North Carolina Kenan-Flagler Business School.

Avi Nandi, SK Pharmteco explores the benefits, challenges, and sustainability impact of on-site media and buffer manufacturing for cell & gene therapy.

Avi Nandi on Simplifying Cell & Gene Supply Chains

Access Part 1 of this interview on how CDMOs simplify cell & gene therapy supply chains by managing lead times, consistency, and material expiry.

, Avi Nandi, president of SK Pharmteco Cell & Gene North America, shares his perspective on emerging technologies reshaping how cell and gene therapy manufacturers handle media and buffer production.

Nandi speaks on a product showcase focused on simplifying on-site media and buffer manufacturing, a technology designed to bring supply chain control directly to manufacturers and service providers. He sees clear advantages in this approach.

"Having internal control of the supply chain, the manufacture of media and buffers, is a huge benefit," he notes, pointing to the ability to produce materials based on immediate demand while reducing inventory risk, cash exposure, and the threat of expiry when manufacturing schedules shift.

At the same time, Nandi acknowledges that CDMOs face a higher bar for adopting new technologies given the consistency demands of their broad client base. Any variability in media or buffer quality could have downstream consequences that aren't discovered until late in the manufacturing process.

On the topic of sustainability, Nandi offers a nuanced take. Cell and gene therapy is a heavily single-use industry with high consumable use and significant waste, which means sustainability looks different here than in traditional chemical manufacturing.

"The primary lever I would pull is, how do you leverage technologies to then improve productivity to then improve upon sustainability?" he explains. By maximizing productivity and reducing the number of manufacturing runs Avi Nandi, SK Pharmteco, companies can make meaningful environmental gains.

Avi Nandi, SK Pharmteco, explores the benefits, challenges, and sustainability impact of on-site media and buffer manufacturing for cell & gene therapy.

Senior Director
Education, Outreach, and Digital Experience
Open Biopharma Research and Training Institute

In this episode of Manufacturing Intelligence, we break down digital twin use in pharma, from risk reduction and scale-up modeling to AI integration and virtual inspections.

Manufacturing Intelligence: Unpacking Digital Twin Use in Pharma Manufacturing

In this episode of Manufacturing Intelligence, Rick Jaenisch, Senior Director of Education, Outreach, and Digital Experience at Open BioPharma and Chris Cole, Associate Editorial Director at 

, offer a wide-ranging explainer on digital twins in pharmaceutical manufacturing, covering definitions, current applications, practical requirements, and future possibilities.

Jaenisch grounds the discussion in the FDA's own definition, describing a digital twin as information constructs that mirror a physical asset and are dynamically updated with real-world data, emphasizing the crucial distinction between a static virtual model and a true digital twin. "If it isn't updated with either real time or somewhat periodic updates... it's not really a digital twin,” he says. “It's a virtual model."

The conversation highlights two primary use cases: risk reduction and scale-up modeling. By running hundreds or thousands of simulations virtually, manufacturers can identify potential errors and optimize processes before committing to a physical run, effectively letting "the computer fail" cheaply and quickly. Facilities management, AR-assisted operator training, and inventory tracking via RFID are identified as active applications today.

Scaling digital twins to full manufacturing lines requires robust data unification across building management, laboratory information management systems, and inventory systems, a significant integration challenge. Jaenisch identifies AI as essential, noting that "Digital twin without AI is pretty much just a virtual model." Generative AI's ability to find the needle in a haystack makes it indispensable for anomaly detection at scale.

Looking ahead, Jaenisch sees virtual inspection—in which regulators conduct non-disruptive audits through a real-time digital twin—as a compelling frontier. He also flags a persistent human challenge: first-generation employees often resist the increased sensor and camera surveillance that digital twins require, even when the monitoring is automated rather than human-led.

Sr. Fellow
Aseptic and Sterile Products
CRB Group

Fellow
Aseptic & Sterile Products
CRB Group

Todd Vaughn and Christa Myers, CRB, discuss how Robotics are reshaping aseptic pharmaceutical manufacturing, improving efficiency, repeatability, and compliance while demanding new operator skills and capital investment.

Todd Vaughn and Christa Myers on What Robotics Mean for Pharma Manufacturing

rising automation in aseptic manufacturing and growing regulatory focus on sterility.

, Todd Vaughn and Christa Myers, Fellows of Aseptic and Sterile Products at CRB, speak with 

to discuss their panel discussion on the growing role of robotics and automation within the aseptic core of pharmaceutical manufacturing. Their conversation covers where the industry stands today, the opportunities automation presents, and what challenges lie ahead.

Both speakers highlight environmental monitoring, specifically, the automated handling of plates and monitors. As Myers notes, "Every time you stick your hand in a glove to change a plate, which sometimes happens every hour, sometimes happens every two hours, you have to stop your fill line, which means you have to stop production, which means you have to stop manufacturing." Automating this step, she argues, could significantly restore efficiency to fill lines and should have been done years ago.

Beyond environmental monitoring, both emphasize the value of robotics in equipment setup and component handling, citing improved repeatability and reduced reliance on human consistency. However, they are clear that automation doesn't mean fewer people; it means different people with different skills. Operators will need deeper technical knowledge, including mechanical and electronics training, while upstream areas like component prep and sterilization may actually require more staff.

Regulatory expectations are also shifting. As Todd Vaughn states, "Continuous improvement is what's expected now" and operators must be prepared to track trends and demonstrate risk mitigation when regulators come calling. Looking ahead, Vaughn describes the industry as being "right on the edge of novel use to expected use," anticipating that older lines could soon face scrutiny as fully automated systems become the new standard. Vaughn and Myers stress that the industry must also find ways to bring smaller, less-capitalized companies along for this transition, because their contributions to patients remain just as vital.

Todd Vaughn and Christa Myers discuss how Robotics are reshaping aseptic pharmaceutical manufacturing by improving efficiency, repeatability, and compliance while demanding new operator skills.

, Associate Director, Product Management, Digital Projects at Charles River.

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Pharma Fundamentals Episode One: Using Virtual Control Groups to Reduce Animal Testing in Drug Development

Pharma Fundamentals Episode One: Virtual Control Groups in Drug Development

, Associate Director, Product Management, Digital Projects at Charles River

 (EMA) issued a draft qualification opinion

 for a preclinical research methodology to reduce the use of animals in specific dose-range finding studies.

 The new approach method (NAM) would replace standard animal control groups with virtual groups, and once qualified, would allow EMA to accept evidence generated from virtual control groups in medicine approval applications.

 to limit the use of animals in drug development. In April 2025, the agency published its Roadmap to Reducing Animal Testing in to modernize drug development through human-relevant science.

 The core of the initiative is the advancement of NAMs, which include advanced in vitro systems (such as organ-on-a-chip), computational modeling, and artificial intelligence (AI). 

, the FDA draft guidance to reduce or eliminate 6-month primate studies for monoclonal antibodies. The agency also qualified its first AI-based drug development tool, AIM-NASH, and updated guidance to support a transition away from horseshoe crab-derived testing, a move that could spare over one million animals annually.

 To provide regulatory certainty, the FDA launched a searchable database documenting exactly where alternative methods are currently acceptable. Furthermore, the agency has prioritized international alignment, collaborating with global regulators to ensure these new strategies are accepted worldwide.

Virtual control groups are a NAM that can be used to support initiatives to reduce the use of animals in drug development and regulation. According to EMA, characterized control data identify appropriate virtual comparator animals to create virtual control groups that are then used to conduct testing that would be traditional performed on animals.

Laura Lotfi, associate director, Product Management, Digital Projects at Charles River, says that in addition to replacing, reducing, and refining the use of animals, virtual control groups may reduce study timelines and bring more “statistical power”. However, there are limitations to their use, including the reliability of the data.

“The data are highly dependent on the quality, the completeness of the underlying infrastructure that may contain sometimes biases or gaps that can affect the reliability of those results.

They may also be less suitable for certain scenarios,” Lotfi explains. “For example, there are some studies that involve new biological mechanism or rare endpoints, maybe some species that are not very well understood, where the limited historical data are not, quietly there yet, so there is a lack of sufficient historical data that are available. In those cases, traditional approaches may still be necessary.”

In the video above, Lotfi provides an explanation of how virtual control groups are used in drug development, their limitations, and the cost associated with their implementation.

Draft qualification opinion for Virtual Control Groups (VCG) to replace Concurrent Control Groups (CCG) in rat non-GLP Dose-Range Finding (DRF) studies. EMA. March 31, 2026. Accessed April 1, 2026. 

https://www.ema.europa.eu/en/documents/other/draft-qualification-opinion-virtual-control-groups-vcg-replace-concurrent-control-groups-ccg-rat-non-glp-dose-range-finding-drf-studies_en.pdf

EMA consults on virtual control groups to help reduce animal use in medicines development. EMA. Press release. March 31, 2026. Accessed April 1, 2026. 

https://www.ema.europa.eu/en/news/ema-consults-virtual-control-groups-help-reduce-animal-use-medicines-development

FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies. 

https://www.fda.gov/media/186092/download?attachment

FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development. Press release. April 20, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-achieves-year-1-goals-reducing-animal-testing-drug-development

Laura Lotfi, Associate Director, Product Management, Digital Projects at Charles River

Laura Lotfi, associate director, Product Management, Digital Projects at Charles River. Laura is a toxicologist that specializes in digital transformation within drug discovery and safety. She focuses on integrating advanced data platforms and innovative methodologies, such as virtual control groups.

Siegfried Schmitt, PhD, Vice President, Technical, Parexel

Siegfried Schmitt, PhD, is vice president, Technical at Parexel and a member of PharmTech’s Editorial Advisory Board.

Draft Qualification opinion for Virtual Control Groups 5 (VCG) to replace Concurrent Control Groups (CCG) in rat 6 non-GLP Dose-Range Finding (DRF) studies. 

New Approach Methodologies (NAMs). FDA.gov. Accessed April 27, 2026. 

https://www.fda.gov/science-research/science-and-research-special-topics/new-approach-methodologies-nams

Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of Charles River breaks down the basics of virtual control groups in drug development.

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