Biotech Sessions at the 2025 ISPE Europe Annual Conference Highlight ATMPs including Large Molecules and Cell and Gene Therapies
The biotech sector, which includes advanced therapy medicinal products (ATMPs) including large molecules and cell and gene therapies, has been the fastest growing market in the pharmaceutical industry for years and this is not expected to change in the next few decades. In addition to products already on the market and new products in development, the market will additionally grow in biosimilars, biobetters, and combined products such as antibody drug conjugates as well as cell and gene therapies.
In this biotech-focused track at the 2025 ISPE Europe Annual Conference, attendees will have the opportunity to explore the biopharmaceutical facility design landscape through the lens of leading pharmaceutical manufacturers and industry partners from around the world. These presentation topics will offer insight into how continuous manufacturing may successfully be applied to biotech. Speakers will also explain how Annex 1 is to be applied to drug substance manufacturing, which will include insights on how to take a risk-based approach to contamination control strategies. Speakers will also highlight the role of automation within ATMPs and elaborate on how it may reduce the cost of goods. Attendees will also learn to navigate through regulatory guidance and guidelines on ATMPs, with modular technology in the form of mini-factories.
“One Million Liters – Continuous Manufacturing Breaks Barriers”
Trevor Seelert from Evolve Biologics and Neil Gamble from Arcadis will explain how 90 percent of the investigational new drug (IND) applications to the US Food and Drug Administration (US FDA) fail to make it through clinical trials, and how commercial readiness can be severely impacted by the drug development. Seelert and Gamble will provide insight into how end users can stage drug development for commercial deployment and how project professionals can support the end user with one critical design philosophy: continuous manufacturing (CM). They will include a principal case study based on a recent CM project in the US that is able to process one million liters of blood plasma annually at a staggeringly low instantaneous throughput of two liters per minute.
“Reducing the Cost of Goods (CoGs) of ATMPS – How Can Automation Help?”
David Phasey from 3P Innovation, will explain how the CoGs of autologous therapies is considerably higher than conventional treatments which creates payment challenges and may prevent those therapies from becoming available to more patients. For more than a decade, industry representatives, equipment providers, therapy developers, and consulting firms have sought to analyze the drivers of the CoGs for ATMPs to determine how this cost might be reduced. Autologous therapies typically require a significant amount of manual effort from highly skilled and trained operators—this limits the scalability and potential benefits due to economies of scale. Automation is recognized as a tool to enable a combination of scalability, reduce manufacturing costs, and improve quality. Representing the ISPE Biotech Automation Information Technology (IT)/Operational Technology (OT) Special Interest Group (SIG), Phasey will outline what the development of products in other sectors can tell us about the potential to reduce the cost of goods for ATMPs in the future.
“Annex 1 Applied in Drug Substances (DS) – Risk-Based Approach to Contamination Control”
Stephanie Whitmore with Eli Lilly and Company and Paul Osborne with BioPhorum will discuss how Annex 1 can be applied to low-bioburden biologic drug substance manufacturing sites. Whitmore and Osborne will present some of the outputs which aim to enhance clarity for the low-bioburden drug substance manufacturing industry and provide a risk-based roadmap for ensuring consistency in environmental monitoring and contamination control practices across the industry.
“Closed Systems, Closure Playbook, and Closure Analysis Risk Assessment”
Osborne will explain how closed systems are increasingly used in low-bioburden biologic drug substance manufacturing. He will outline a comprehensive risk assessment framework, known as Closure Analysis Risk Assessment (CLARA), which is specifically tailored for the biopharmaceutical industry. Osborne will demonstrate how viable and non-viable agents found in the environment that could potentially contaminate a biopharmaceutical product have been removed from the closed process system prior to the introduction of process or product materials.
“Navigating Through ATMP Guidance and Regulations”
Jon Halling with Catapult Cell and Gene Therapy and Alf Penfold with PM Group will explain how the ATMP sector of healthcare is rapidly evolving and expanding with some unique challenges such as microbial contamination and product variability. Halling and Penfold will discuss some of the differences in approach and content regarding the regulations and guidelines that apply. Learn how to navigate through some of these differences including when and how to apply EudraLex Annex 1 (manufacture of sterile medicinal products), ICH Q9 (quality risk management), and ICH Q5 (viral safety evaluation).
“Emerging Technologies Applied for Cycle Development of a Fully Gloveless Aseptic Isolator”
Bianca Bohrer from PSM GmbH Topmedicare and Theresa Ladwig from SKAN AG will present on how aseptically processed biopharmaceuticals and emerging technologies create increasing demands on the H2O2 decontamination cycle times, effectiveness, and permitted H2O2 residual limits. Bohrer and Ladwig will cover the latest innovations in H2O2 decontamination and their advantages when meeting the latest cGMP and regulatory requirements such as Annex 1, including the many new challenges with fully gloveless isolators.
“Enabling Fully Continuous Inline Viral Inactivation”
Elizabeth Goodrich with MilliporeSigma will present on a continuous viral inactivation step in the monoclonal antibodies (mAb) downstream train. Evidence of intensified, integrated, and continuous process adoption has increased as the biomanufacturing community drives innovation and advances enabling technologies, although challenges remain in translating from vision to reality for fully connected processing; particularly in the areas of scale-down tools and integrated control. Viral inactivation is a step in the mAb downstream train where a fully continuous option is lacking. MilliporeSigma has developed a prototype process-scale inline viral inactivation system (iVI) implementing coiled-flow inverter incubation chambers. Goodrich will present results showing the implementation of the iVI system for viral inactivation, robustness of the residence time distribution (RTD) model, a strategy for bench-scale determination of process parameters, and a scale-up demonstration.
“Establishing Biopharma Drug Substance Manufacturing Capability”
Marina Ferrari with Chiesi Farmaceutici and Angelo Bernardis with Wood, who is serving as Co-chair of ISPE Biotech Automation IT/OT SIG within the Biotech CoP, will introduce the new state-of-the-art biotech center of excellence established by Chiesi for the development and production of Mab’s, enzymes and therapeutic proteins. This initiative represents a significant enhancement and innovation to bring new treatments to the market for the Company, a well-established international Firm operating in the research and manufacturing of respiratory health, rare diseases and specialty care pharmaceuticals. The presentation will introduce the passionate journey for the scaleup of a promising product, the challenges of the tech-transfer from a Third-party contractor, the design of the facility with the support of Wood as A&E for the realization/startup, how Chiesi has grown/trained the staff to operate the plant – ultimately showing how the plant is ready for efficient/flexible development/manufacturing of multiple products at different scales under full GMP compliance.
Overall, this entire track has been carefully curated to highlight real-world examples and trending challenges behind biopharmaceutical facility design. Whether starting from scratch or implementing improvements to a brownfield facility, this track seeks to posture the conversation to ask all the right questions and set facility design projects up for success.
