Thursday 18th September - Main Conference Day Three - ET (Eastern Time, GMT-05:00)
- Colette Ranucci - Vice President, Global Large Molecules, Technical Operations, Merck
- Lina Chakrabarti - Associate Principal Scientist, Astrazeneca
- Jianlin (Jim) Xu - Global Head of Cell Culture Platform, Sanofi
- Keshab Rijal - Principal Scientist, Amgen
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, North Carolina State University
- Joseph Silhavy - Senior Scientist, Pfizer
- Abraham Lenhoff - Allan P. Colburn Professor, University of Delaware
Automation is rapidly transforming downstream processing by improving reproducibility, reducing labor costs, and accelerating timelines. This talk will focus on the integration of automation technologies in the downstream workflow, from automated chromatography systems to robotic liquid handling and filtration. The speaker will discuss how automated systems enhance productivity, improve process control, and allow for more consistent and scalable processes.
- Wei Huang - President, Henlius Biopharmaceutical Ltd, China
- Yuxin He - Sr Engineer II, Moderna
This session will provide practical advice for bioprocess programs navigating post-approval submissions and late-stage commercialization. A key focus will be post-approval comparability, including strategies for managing situations where materials fall outside of established acceptance criteria. The talk will explore the use of risk assessment.
- Kat Kozyrytska - Managing Director, Kozyrytska Consulting
- Wei Zhang - Director, Analytical Development, Ultragenyx Gene Therapy
This session will delve into the complex regulatory landscape surrounding the use of Artificial Intelligence (AI) and Machine Learning (ML) in the development, manufacturing, and quality control of biologics. Experts will discuss evolving guidelines from regulatory agencies, including best practices for validating AI/ML models, ensuring data integrity, and demonstrating the reliability and transparency of AI/ML-driven decisions, panelists will deliver strategies, improvements in processes, and lower costs of operations through the proper application of the data. Key focus areas include strategies for generating trust and confidence in AI/ML-based analytics for regulatory submissions and maintaining compliance throughout the product lifecycle with specific actionable strategies
- What to start early in the process?
- How early is too early to consider strategy for scaling up?
- How to define the right commercial scale early in development
- Best practices for locking in scalable processes from the start
- Designing therapies with long-term success in mind—beyond Phase 1
- Key considerations for commercial scale up, reimbursement, raw material availability, and regulatory approvals
- Pathways to developing safe, reimbursable therapies with broad patient access
- Francesca Vitelli, PhD - Former VP Cell Therapy and Viral Vector PD and MSAT, Intellia Therapeutics, Inc
- Jeff Masten - Senior Vice President CMC, Secretome Therapeutics
- Kate Rochlin - Chief Operating Officer, IN8bio
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
- Nicola Ambler - Co-Founder, CGT Circle
- Justin Skoble - Vice President of Technical Development, Caribou Biosciences, Inc.
- Monica Raimo - Director, Product and Process Development, Glycostem Therapeutics
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
- Rajeev Boregowda - Associate Director, Bioassay & Molecular Analytical Development, Genomic Medicine CMC, Sanofi
- Sarah Thomas - Senior Vice President, Quality, REGENXBIO Inc.
- Ying Cai - MSAT Executive Director, Ultragenyx Pharmaceutical
Spotlight Presentation – Calling all Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
This talk will focus on the steps and procedures necessary to produce a drug product, starting with a biologic drug substance. This is the final step in drug manufacture and the only set of procedures that must be done aseptically. The typical testing procedures for drug product will also be discussed.
- Frank Riske, Ph.D. - Founder and Principal Consultant, Deep Dive Biotech Consulting
- Shahid Uddin - Senior Director, Formulation Development and Laboratory Operations, CMC, Immunocore
- Frameworks for evaluating make vs. buy decisions in biopharma.
- Identifying core competencies and areas ripe for outsourcing.
- Balancing control and flexibility in manufacturing choices.
- Case studies illustrating successful outsourcing strategies.
- Leveraging CDMO expertise for specialized technologies and capabilities.
- Mitigating risks and enhancing supply chain resilience through external partners.
- Accelerating speed to market and managing capacity constraints.
- The role of external manufacturing in supporting innovation pipelines.
Join us for an enlightening session where corporate professionals and industry leaders share insights about diverse scientific career paths that students may not have previously considered.
- Discovering Hidden Scientific Careers - Exploration of lesser-known scientific roles across various industries
- Research Opportunities Beyond Academia - How scientific research thrives in corporate environments
- Educational Pathways and Requirements - Guidance on academic qualifications needed for different scientific careers
- Advancement Trajectories in Scientific Fields - Career progression possibilities within scientific disciplines
- Mentorship and Networking in Science - How to build professional relationships that foster career growth
- Technological Integration in Scientific Roles - The evolving landscape of technology-driven scientific careers
- Adaptability and Transferable Skills - How scientific training creates versatile professionals across sectors
- Leadership Opportunities for Scientists - Pathways from technical roles to management and executive positions
- Emerging Fields and Future Trends - New scientific disciplines and careers on the horizon
Addition of trehalose during harvesting process decreased conductivity of CHO cell culture fluid and reduced host cell proteins in a filtrate. This effect was demonstrated by filtration using 3M™ Harvest RC chromatographic clarifier. Our findings suggest an entirely new approach to reducing carry-over of impurities into later purification process.
- Kotaro Hashimoto - Scientist, Nagase Viita
The Exhibition Stage proudly hosts our distinguished poster competition winners, showcasing exceptional research contributions that have demonstrated outstanding merit, innovation, and impact in their respective fields.
- Daniel Burke - Senior Scientist, Merck
- Shu Wang - Principal Investigator, Incyte
- Andrei Arion - Associate Scientist, Cell Line and Upstream Process Development, Alexion, AstraZeneca Rare Disease
- Jongyoon Han, Ph.D. - Professor, PI of the Micro-Nanofluidic BioMEMS group at RLE, Massachusetts Institute of Technology
- Yi Li - Process Development Principal Scientist, Amgen, Inc.
- Chris Barton - Director, Analytical Development, Takeda
- Kimberly Larson - Principal Scientist, Boehringer Ingelheim
This talk could address the increasing demand for biologics and discuss innovative solutions for capacity expansion, including modular facilities, process intensification, and improved resource utilization.
- Marshall Ma - Founder & CEO, PharMAsafe
- Divyanshu Malhotra - Scientist, Genmab
Traditional QC methods often cause bottlenecks due to their slowness, labor intensity, and variability. This session explores cutting-edge automation solutions, high-throughput analytics, and real-time release testing (RTRT) designed to dramatically enhance efficiency and data integrity in biopharmaceutical QC, streamline workflows, and accelerate testing. As gene and cell therapies move to commercial manufacturing, you'll learn how to scale QC processes, ensure assay transferability, and maintain data integrity across production sites. The session will cover implementing RTRT and high-throughput analytics, strategies for harmonizing QC across multiple manufacturing locations, and the rise of plug-and-play analytical tools. Attendees will gain actionable insights for optimizing QC operations, improving process control, ensuring compliance, and reducing risk during commercial expansion. Learn about next-gen QC strategies that increase efficiency, improve consistency, and ensure regulatory compliance while reducing product release bottlenecks.
Onechain Immunotherapeutics developed a stromal-free bioprocess for the novo generation of γδ T cells from cord blood (CB) CD34+ HSPC or iPSC-derived CD34+, using recombinant Notch ligands, eliminating the need for expanding these cells from peripheral blood or other sources. The process can yield functional γδ T cells that can be armed with CARs with cytotoxic activity against multiple cancer cells. This strategy is highly scalable, consistent with GMP guidelines, and represents a step forward in the field of allogeneic, off-the-shelf CAR-T cell therapies.
- Victor Manuel Diaz Cortes - Research Director, OneChain Immunotherapeutics S.L.
Through a series of case studies this session will focus on the latest innovations and advances in next-generation therapies.
- Explore cutting-edge preclinical and clinical case studies driving the future of cell and gene therapy.
- Discover how data-driven innovation is transforming therapy development, from control and targeting to tackling undruggable diseases.
- Unpack the challenges vs. traditional approaches, advancements in new modalities, and the manufacturing needs shaping commercialization of future therapies.
Key Case Studies Areas Include:
- Gamma Delta T Cells & T Cell Engagers
- mRNA, RNA, & NK Therapies
- Multiplex & Combination Cell Therapies
- 3D Bioprinting & Scaffold Development
- Solid Tumours & Expanding Disease Areas (Autoimmune, Neurology, Cardiometabolic)
- Marcus Lehmann - Associate Director, Drug Product Process Development, Satellite Bio
- Nicole Santimauro - Senior Engineer, Manufacturing Science and Technology, Century Therapeutics, Inc.
- Yuechen Zhu - Staff Development Scientist, Bayer
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
- Wei-Chiang Chen - Associate Director, BioProcess Analytics, Genomic Medicine Unit, Sanofi
UX701 is an investigational AAV9 gene therapy designed to deliver a modified form of the ATP7B gene for the treatment of Wilson Disease. UX701 leverages Ultragenyx’s proprietary producer cell line platform, Pinnacle PCL™, to produce rAAV at 2000L scale.
Process characterization of UX701 is an essential aspect of the process validation lifecycle, aimed at defining manufacturing process ranges to maintain the target product profile (TPP). A risk-based approach was applied to the late-stage development activities for UX701 upstream and downstream process including process parameter and raw materials risk assessment, scale-down model (SDM) qualification, and process characterization (PC) studies, to establish process controls and inform parameter criticality for the upstream and downstream unit operations in the 2000L manufacturing process. We assessed over 400 upstream and downstream process parameters for their impacts to process performance indicators (PIs) and critical quality attributes (CQAs) and classified them into high, medium or low risk parameters. Of these we studied 11 high and medium risk upstream process parameters and 2 raw materials, and 14 high and medium risk downstream process parameters in PC studies.
We identified 8 process parameters in upstream and 3 downstream process parameters to be critical (CPP) or key (KPP). In the upstream process, temperature and pH, seeding density, and helper virus concentration were all found to be CPPs during production. In the downstream process, viral heat inactivation step, temperature and time affect the inactivation kinetics of the helper virus. Characterization of our anion-exchange (AEX) polishing chromatography step identified an upper threshold which the load conductivity should stay below to ensure binding onto the AEX column.
In this work, we have characterized the cell culture and purification manufacturing process and demonstrate a robust and high yielding process for the manufacture of UX701. This is the first PC campaign for our Pinnacle PCL™ rAAV gene therapy manufacturing platform.
- Jun Li - Associate Director – Upstream Process Development: Gene Therapy, Ultragenyx Pharmaceutical
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
- Shahid Uddin - Senior Director, Formulation Development and Laboratory Operations, CMC, Immunocore
- Laurence Whitty-Léveillé, Ph.D - Associate Principal Scientist, Merck & Co., Inc.
Patient convenience and the need for self-administration are fueling the demand for prefilled syringes and autoinjectors for biologics, requiring specialized formulation and fill finish capabilities.
- Key FDA regulations and guidelines relevant to CDMO partnerships (e.g., 21 CFR Parts 210 & 211).
- Understanding and implementing robust quality agreements.
- Navigating supplier qualification and audit processes.
- Strategies for maintaining compliance throughout the partnership lifecycle.
- Establishing clear communication channels and quality agreements that foster a shared commitment to quality.
- Implementing effective oversight and monitoring systems for CDMO operations.
- Navigating differences in quality cultures and ensuring alignment.
- Leveraging technology and data to enhance quality and compliance in external manufacturing.
- Addressing challenges related to investigations, deviations, and CAPAs across organizations.
- Building trust and transparency as foundational elements of a strong quality partnership.
The Exhibition Stage proudly hosts our distinguished poster competition winners, showcasing exceptional research contributions that have demonstrated outstanding merit, innovation, and impact in their respective fields.
The Exhibition Stage proudly hosts our distinguished poster competition winners, showcasing exceptional research contributions that have demonstrated outstanding merit, innovation, and impact in their respective fields.
Join us for an informative session where publishing experts from Taylor & Francis will guide you through the complete journey from manuscript preparation to successful publication of your research.
Topics to be Covered:
- Choosing the Right Publication Path - Understanding the differences between journal articles, books, and open access options
- Proposal Development and Submission - Creating compelling book proposals or selecting the appropriate journal for your research
- Navigating the Peer Review Process - What to expect during initial and developmental peer review stages
- Understanding Publishing Contracts - Key elements including royalties, copyright, and delivery timelines
- Manuscript Preparation Guidelines - Formatting requirements, image specifications, and permissions
- Open Access Opportunities - Exploring pay-to-publish models and transformative agreements
- Production and Editorial Processes - Working with editors to refine your content for publication
- Digital Enhancement Options - Leveraging Taylor & Francis's digital platforms to increase visibility
- Post-Publication Promotion - Strategies to ensure your research reaches the right audience
- Building Your Publishing Portfolio - Long-term strategies for academic and professional authors
Challenges like high costs, scale-up complexity, and prolonged time to manufacture prevent cell therapy from reaching its full potential. Induced pluripotent stem cells (iPSCs) could provide an inexhaustible cell source, expanding their applicability to new medical areas. In this work, the benefits of stirred-tank bioreactors for iPSC culture were explored in 1 L vessels controlled by the SciVario® twin bioreactor.
- Min Tang-Schomer - Senior Research Scientist, Eppendorf
This presentation explores the application of mechanistic AI to accelerate biopharmaceutical process development. We showcase case studies involving model-based design for mAb and mesenchymal stem cell cultivation, achieving development cost reductions of up to 90%. In addition, the talk introduces a data-driven framework for automatically extracting underlying mechanisms and constructing corresponding models from time-series concentration data, highlighting its potential to streamline early-stage development.
- Junu Kim - CEO, Auxilart Co., Ltd.
This presentation explores the application of mechanistic AI to accelerate biopharmaceutical process development. We showcase case studies involving model-based design for mAb and mesenchymal stem cell cultivation, achieving development cost reductions of up to 90%. In addition, the talk introduces a data-driven framework for automatically extracting underlying mechanisms and constructing corresponding models from time-series concentration data, highlighting its potential to streamline early-stage development.
- Junu Kim - CEO, Auxilart Co., Ltd.
Super Refined™ Poloxamer 188, optimized for cell culture, addresses variability issues in bioprocessing caused by impurities in standard Poloxamer 188. Demonstrating enhanced cell viability in CHO and HEK lines, this study validates its performance and batch consistency through analytical characterization, offering a reliable solution for high-performance biomanufacturing applications.
- Kritika Bajaj - Lead Research Scientist, Croda
- Efecan Aral - Postdoctoral Associate, Cell Science and Technology, Sanofi
- Jacqualyn Schulman, Ph.D. - Scientist, Cell Line Development & ‘Omics Biologics Development, Bristol-Myers Squibb
- How to ensure safety and compliance while accelerating clinical and manufacturing timelines
- Common pitfalls and best practices
- Strategies to address changing regulatory requirements during rapid development
- Strategic approaches to transitioning from clinical development to manufacturing readiness
- Aligning speed with regulatory expectations for product quality and safety
- Sinead Dullaghan - Sr. Principal Scientist TSMS, Eli Lilly
- Sreejit Menon - Research and Technology Director ‐Life Sciences, Croda
- Emma Cooper - Process Development Engineer, Regeneron
- Sidharth Razdan - Senior Scientist, Pfizer
- Moira Lynch - Director, Innovation, Thermo Fisher Scientific
- A Representative from Biophorum - -, BioPhorum
- Yu-Tsan (Richard) Liu - Sr. Scientist, UCB Pharma
- Seth Levy - Senior Director, Bioprocess Development, Modalis Therapeutics
- Shashi Prajapati - Director, Cell & Gene Therapies Analytical Development, Vertex Pharmaceuticals
- Rosalind Ang - Associate Principal Scientist - Biologics & Analytical Research & Development, Merck
- Reagan Jarvis - Chief Executive Officer and Co-founder, Anocca
- Jeron Chen - Head of Data Science and Payload Innovation, Voyager Therapeutics
Join industry leaders as we explore how AI, digitalization, and advanced analytics are transforming cell and gene therapy manufacturing. This dynamic panel will dive into:
- AI-Powered Manufacturing: How AI-driven models, predictive analytics, and digital twins are optimizing process control
- Process Analytical Technologies (PAT): The latest breakthroughs in real-time monitoring, automation, and data-driven decision-making
- Overcoming Data Challenges: Strategies to build robust AI models despite limited datasets
- Success Stories: Case studies showcasing AI and PAT integration for improved yield, efficiency, and product quality in cell and gene therapy manufacturing and process development
- Kat Kozyrytska - Managing Director, Kozyrytska Consulting
The Biophorum ATMP Visible Particles workstream has proposed a holistic, lifecycle approach to reduce and de-risk visible particulates in cell therapy (CT) drug formulations. This involves characterizing and detecting particulates in the manufacturing process and formulation, then improving material quality and process controls to minimize them.
CTs face unique challenges in particulate control and detection compared to other injectables, including difficult-to-inspect formulations and containers. CTs, with inherent cell-related particulates, complicate the detection of other particles. Terminal sterilizing filtration isn't applicable due to cell size and formulation needs. Small batch volumes, especially in autologous therapies, make rejecting units with particle defects critical. Regulatory guidance and health authority expectations are not aligned with the unique characteristics of cell and gene therapies, posing challenges for sponsors in meeting particulate specifications.
- Shankar Swaminathan, PhD - Team Lead, Associate Director Drug Product Development, Astellas Institute for Regenerative Medicine
- Jeron Chen - Head of Data Science and Payload Innovation, Voyager Therapeutics
Join industry leaders as we explore how AI, digitalization, and advanced analytics are transforming cell and gene therapy manufacturing. This dynamic panel will dive into:
- AI-Powered Manufacturing: How AI-driven models, predictive analytics, and digital twins are optimizing process control
- Process Analytical Technologies (PAT): The latest breakthroughs in real-time monitoring, automation, and data-driven decision-making
- Overcoming Data Challenges: Strategies to build robust AI models despite limited datasets
- Success Stories: Case studies showcasing AI and PAT integration for improved yield, efficiency, and product quality in cell and gene therapy manufacturing and process development
- Kat Kozyrytska - Managing Director, Kozyrytska Consulting
- Pierre-Axel Vinot - Associate Director, CMC Portfolio Management, SparingVision
- Jeron Chen - Head of Data Science and Payload Innovation, Voyager Therapeutics
Join industry leaders as we explore how AI, digitalization, and advanced analytics are transforming cell and gene therapy manufacturing. This dynamic panel will dive into:
- AI-Powered Manufacturing: How AI-driven models, predictive analytics, and digital twins are optimizing process control
- Process Analytical Technologies (PAT): The latest breakthroughs in real-time monitoring, automation, and data-driven decision-making
- Overcoming Data Challenges: Strategies to build robust AI models despite limited datasets
- Success Stories: Case studies showcasing AI and PAT integration for improved yield, efficiency, and product quality in cell and gene therapy manufacturing and process development
- Kat Kozyrytska - Managing Director, Kozyrytska Consulting
- Samir Mitragotri - Hiller Professor of Bioengineering, John A. Paulson School of Engineering & Applied Sciences, Wyss Institute, Harvard University
- Christina Vessely - Principal Consultant, CMC Analytical and Formulation Development, Biologics Consulting
Subcutaneous delivery of biologics via self-dosing devices is increasingly essential for chronic disease management, yet development remains slow and costly—often requiring years and tens of millions of dollars due to formulation redevelopment and complex clinical trials. A key barrier is the disconnect between drug and device development, regulated under separate frameworks (21 CFR 210/211 vs. 820). This talk introduces an integrated approach for drug and device development from project inception to commercial launch and provide effective toolboxes along the development phases.
- Yu (Eunice) Tang - Executive Director, PharmDev and Manufacturing, Syndax Pharmaceuticals, Inc
- Defining clear requirements and objectives in your RFP.
- Key criteria for evaluating potential CDMO partners (e.g., technical capabilities, quality systems, financial stability, cultural fit).
- Best practices for conducting thorough due diligence (technical, quality, financial).
- Utilizing site visits and audits effectively.
Small group discussions focused on specific challenges in CDMO selection, such as:
- Phase-appropriate CDMO selection & finding CDMOs with niche capabilities (e.g., specific cell lines, advanced therapies).
- Balancing cost, quality, and timelines in the selection process.
- Building trust and transparency in the initial stages of partnership.
30min table discussion
10 minute findings feedback to the group for each table
- Harsh Chauhan - Director, Formulation Development and External Manufacturing, Alltrna Inc.
- Katie King, PhD - CEO & Co-Founder, BioOrbit
- Ronald Rabin - Chief, Laboratory of Immunobiochemistry, CBER, FDA