Thursday 18th September - Main Conference Day Three - ET (Eastern Time, GMT-05:00)
- Colette Ranucci - Vice President, Global Vaccines Science & Technology, 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
For commercial programs, robust process controls go beyond accuracy and precision, and require reliability, transferability and robustness. In-line spectroscopy-based process analytical technologies (PAT) have created an opportunity to address those concerns. PAT are common in bioprocessing and are highly scalable with a wide range of applications including determining product, solvent, and impurity concentrations. A cross-functional team including development and manufacturing have focused on the implementation and development of in-line near infrared (NIR) spectroscopy for glycoconjugate programs. Key learnings from development and manufacturing regarding model development, implementation, and validation were analyzed to investigate and expand PAT applications across multiple glycoconjugate programs.
- 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 - Consultant, Cell Therapy Manufacturability Program
- Wei Zhang - Director, Analytical Development, Ultragenyx Gene Therapy
- Nathan Yozwiak - Head of Research, Gene and Cell Therapy Institute (GCTI), Mass General Brigham
- Francesca Vitelli, PhD - Former VP Cell Therapy and Viral Vector PD and MSAT, Intellia Therapeutics, Inc
- Jeff Masten - Senior Vice President CMC, Secretome Therapeutics
- Brian Laskowski - VP, Head of Quality Assurance CMC, Beacon Therapeutics
- Kate Rochlin - Chief Operating Officer, IN8bio
- 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.
- Jun Li - Associate Director – Upstream Process Development: Gene Therapy, Ultragenyx Pharmaceutical
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
- Gil Roth - President, Pharma & Biopharma Outsourcing Association
- Prioritising strategic value and technological fit over cost.
- Moving from contract oversight to building true strategic alliances and relationships.
- Leveraging CDMOs to access innovation.
- Integration for Speed: Aligning partnerships to directly accelerate development timelines and time to market.
This presentation outlines a systematic, data-driven framework for evaluating the developability of biologic therapeutics, with emphasis on pre-formulation. An IgG1 monoclonal antibody case study demonstrates key methodologies, including in silico stability profiling, forced degradation, formulation screening via DoE, and predictive modeling, to support early risk assessment and formulation strategy development.
- John Rockwell - Manager, BioChemical Analysis, BioAnalytics, Catalent
This poster presents a customized mass spectrometry approach for sub-ppm quantitation of high-risk host cell proteins (HCPs) considered critical quality attributes. Enhancements to standard HCP-MS workflows enable sensitive detection of immunogenic or enzymatic HCPs. DnaK is used as a model to demonstrate method specificity and performance.
- Shawn Fitzgibbons - Principal Scientist, BioAnalytics, Catalent
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
- Joshua Pierce - CEO + Founder, Dream Opportunity
- Greg Hammond - Head of Technical Operations, BioTalent
We present the automated Cloning Platform using microfluidic GRIDs for efficient hiPSC genome editing. By leveraging interfacial tension and optical clarity, single cells are cultured in traceable nanoliter chambers. The platform delivers high cloning efficiency, reduced workflow complexity, and robust maintenance of pluripotency in genome-engineered hiPSC clones.
- Matthias Hoja - Sales and Business Development Manager, iotaSciences Ltd.
Advancing an ADC biosimilar upends the workflows with which we are most familiar. Clinical benefits have already been established, and the primary goal is to establish comparability with the existing product. Presented herein are strategies that enabled completion of three Kadcyla® PPQ runs within five months of Pivotal execution.
- Jonathan Rheuben - Managing Director, MabPlex
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
- 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.
- Victor Manuel Diaz Cortes - Research Director, OneChain Immunotherapeutics S.L.
- Tamás Kitka - Founder, Managing Director, CREATe Therapeutics
- Marcus Lehmann - Associate Director, Drug Product Process Development, Satellite Bio
- 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
- David Dobnik - Research Councillor, National Institute of Biology
- Pierre-Axel Vinot - Associate Director, CMC Portfolio Management, SparingVision
- 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.
- Regulatory standards – 21 CFR Parts 210 and 211
- Quality Agreement development and Implementation
- Supplier Qualification and Audit – risk based approach - paperbased vs. on onsite
- Compliance and lifecycle Management
- Audit Readiness
- Q&A
- Georgia Sloboda - Managing Director, CMC, Sia/LBG
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.
- Cheryl Scott - Editor in Chief, BioProcess International
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
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.
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
High-concentration Tangential Flow Filtration (TFF) (>200 mg/mL) presents challenges such as high viscosity, fouling, and flux loss. In this Poster we discuss the optimization of transmembrane pressure, crossflow rate, and recovery procedure to reduce the C-gel point. This strategy enabled >250 mg/mL concentration with consistent recovery and purity, even at scale.
- Anindita Das - Senior Director, Process Development, Kemwell Biopharma
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
- Caroline Mahl - Team Lead, Cell Culture Development, Lonza
- 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
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, North Carolina State University
- Emma Cooper - Process Development Engineer, Regeneron
- Sidharth Razdan - Senior Scientist, Pfizer
- Moira Lynch - Director, Innovation, Thermo Fisher Scientific
- Kat Kozyrytska - Consultant, Cell Therapy Manufacturability Program
- 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
- Kat Kozyrytska - Consultant, Cell Therapy Manufacturability Program
- Shankar Swaminathan, PhD - Team Lead, Associate Director Drug Product Development, Astellas Institute for Regenerative Medicine
- Kat Kozyrytska - Consultant, Cell Therapy Manufacturability Program
- Jeron Chen - Head of Data Science and Payload Innovation, Voyager Therapeutics
- Kat Kozyrytska - Consultant, Cell Therapy Manufacturability Program
- 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