Tuesday, September 24, 2024 - Day One of Main Conference - EST/EDT (Eastern Daylight, GMT-4)
Tuesday, September 24, 2024 - Day One of Main Conference - EST/EDT (Eastern Daylight, GMT-4)
- Niklas Engler - Global Head and Vice President, Technical Development Portfolio and Projects, F. Hoffmann-La Roche
- Ron Weiss - Professor of Biological Engineering, MIT Synthetic Biology Lab
- Thomas Kelly - Director, Cell Engineering & Analytical Sciences, Johnson & Johnson Innovative Medicine
Transposase/Transposon platforms have become increasingly common for the development of robust high-expressing CHO cell lines for protein therapeutic manufacturing. Notably, these techniques use a single transposase/transposon pair to enable such outcomes. ATUM, as part of the Leap In Transposase platform, has developed a number of mutually orthogonal transposase/transposon pairs that can be used to serially engineer CHO, and other, cell lines in a robust manner. Indeed, this engineering can be used to not only increase the expression of transgenes, as is the case for a mAb therapeutics, but also knock-down the expression of endogenous genes to affect cellular physiology and/or product quality attributes … or both. This talk will provide examples of such engineering including a case study wherein three orthogonal Leap In Transposase/Transposon systems were implemented for the creation of a mAb expressing cell line with specific product quality attributes.
- Oren Beske, Ph.D. - Amalgamator of Business and Biology, ATUM
Considerations when designing a scale up strategy; Tools for scale up calculation and facility fit assessment; Case studies.
- Jianfa Ou - Principal Scientist, Biologics Development, Global Product Development and Supply, Bristol Myers Squibb
This presentation will cover the strategy for clone and process platform selection for a therapeutic fusion protein. The selection process involves generating clonal cell lines, assessing the cell culture process performance, and evaluating product quality attributes in automated microbioreactors. Perspectives from product development, analytical product quality comparability, cost of good reduction, and strategies for further process development will be discussed.
- Vida Rahmatnejad - Upstream Process Development Scientist, Alexion
- Nick Vecchiarello, Ph.D., - Assistant Professor, Chemical Engineering, University of Virginia
- Elise Woodall - Automation Engineer, AstraZeneca
- Amish Patel - SVP, Technical Activity Operations, Calidi Biotherapeutics
The focus on accelerated development of new modalities for advanced therapies and challenges with complex drug candidates has driven adoption of novel concepts and technologies in biopharmaceutical development and manufacturing. The active drug substances have become more structurally complex and R&D timelines continue to be compressed, the technologies necessary to provide safe, robust and economical access to these molecules needs to keep pace. Emerging technologies such as continuous processing, automation, high throughput experimentation, predictive modeling in an integrated fashion can expedite process development and commercial manufacturing while ensuring efficiency and delivering quality products. All these aspects help to minimize the time and cost associated with development and manufacture of drugs and bring medicines to patients more effectively. This presentation will share AbbVie’s strategy and experiences in integrating such end-to-end technologies into process development and manufacturing facilities and discuss the challenges and opportunities associated with our approaches.
- Moiz Diwan - Director, Purification Development, Biologics Development - Operations, AbbVie
Given the complexity of biological products, effective control strategy and life cycle management are critical to delivering quality products with intended efficacy. This presentation will focus on an overview and guidelines to develop and implements analytical control strategy approach to streamline and harmonize quality control testing and method life cycle.
- Udayanath Aich, Ph.D. - Associate Director, Bristol Myers Squibb
- Matthew Radle - Scientist, Analytical Sciences, AstraZeneca
- Derek Ryan - Senior Director, Analytical Development, KBI BioPharma
- Sung Hyun Choi, Ph.D. - Director & Head of R&D Center, Affyxell Therapeutics Co., Ltd.
- Marinna Madrid - Co-Founder & Chief Product Officer, Cellino
- Kathryn Golden - SVP, Technical Operations and Cell Manufacturing, bit.bio
- Tania Emi - Senior Scientist - Cell Process Development, Beam Therapeutics
- Ashish Saksule - Principal Scientist, Core Lead, Vertex Pharmaceuticals
- Stacie Seidel - Senior Director Molecular/Viral Vector Biology, elevatebio
- Janet Lee - Head of Cell Line Development, Samsung Biologics
- YeonTae Jeong - Head of Upstream Process Development, Samsung Biologics
In the biopharma industry, various techniques are utilized to enhance yield and quality of the target protein produced by stable cell pools and accelerate overall CLD timeline. In this presentation, we will show a case study of a method for minipool productivity enrichment via co-expression of the target protein with a fluorescent biosensor protein using an IRES, combined with state-of-the-art automation tools to allow productivity enhancement and reduce timeline for overall cell line development efforts.
- Jishna Ganguly - Expert Scientist, GSK
Cell Line Development plays a crucial role in establishing Master Cell Banks for clinical and commercial biomanufacturing. This involves creating subclones and undergoing multiple stages of rigorous assessment, leading to the selection of a final clone used for the project's entire duration. Decision-making in this process hinges on extensive datasets obtained from advanced analytical methods. The introduction of high-throughput platforms like the Berkeley Light Beacon and automated micro-bioreactor systems has resulted in generating vast datasets, which often consist of thousands of data points in each experiment. Moreover, the need to integrate process and performance data from various scales, including deep-well plates, shake flasks, and bioreactor processes, is essential for a thorough analysis. Collectively, these factors pose significant challenges in data processing and analysis, which are critical for informed decisionmaking in Cell Line Development. Here, we propose a holistic method for digitizing the entire cell line development and selection process. Our approach begins with implementing laboratory and data automation tools to streamline the generation and handling of raw data. We then establish automated data pipelines using the Databricks platform, enabling the integration of various data types and data of different scales into a specially designed database. This database comprehensively encompasses data on cell line creation, assessment, and selection. Additionally, we develop visualization dashboards linked in real-time to the database, significantly reducing time spent on data processing. Finally, we leverage this streamlined data to build predictive models using open-source Python machine-learning algorithms, enhancing the cell line selection process. Our proposed digital framework ensures a data-driven approach, optimizing the selection of highquality cell lines for clinical and commercial manufacturing purposes.
- Yi Li - Process Development Scientist, Amgen, Inc.
- Michael Chen, PhD - CEO & Co-founder, Great Bay Bio
- Winnie Yeung - Scientist, Gilead
Antibody drug conjugate therapeutics are an increasingly common modality due to their targeted ability to deliver various cytotoxic or immune-modulating payloads to specific cell types or tissues. This presentation covers a case study navigating the added complexity of selecting an appropriate mAb binder, payload, conjugation method, and drug-antibody ratio with emphasis on opportunities and challenges to accelerate pre-clinical development and IND filing.
- Kyle McHugh - Associate Director, Biotherapeutics Process Development
- Harun Ozbakir, Ph.D., - Senior Scientist, Process Development, Amgen
- An update on NIIMBL’s activities working towards key fundamentals
- Security of supply chains
- Flexibility of facilities to match varied and changing demand across portfolios of products
- Faster development with supply chains that can match this
- Sustainability for raw materials, components, and energy
- Amish Patel - SVP, Technical Activity Operations, Calidi Biotherapeutics
- Jeffrey Baker - Senior Fellow, NIIMBL; Strategic Advisor, CBI-MIT
- John Schiel, Ph.D. - Research Chemist, IBBR, National Institute of Standards and Technology
- Brian Fahie, Ph.D. - Vice President, Global Head of Analytical Development, Biogen
- Courtney Hazelton-Harrington - Senior Scientist, Research & Development, Lonza Biologics
- Amir Hefni - CEO, Resolution Therapeutics
- Meghan Samberg - Chief Development Officer, Stemson Therapeutics
- Reducing wait times and logistical magnitude to reduce overhead costs
- Increasing accessibility, distributing to multiple locations closer to patient populations and remove transportation cost barriers
- How QC release testing and material kitting and management will be handled for POC manufacturing in this ecosystem.
- Establishing harmonized regulatory standards across different regions
- Implementing robust oversight mechanisms to ensure compliance with regulatory requirements and maintain product in a distributed manufacturing model.
- EMA vs FDA approach
- Peter Peumans - CTO Health, imec
- Jing Liao - Director of Vector Development and Operations, Alexion Pharmaceuticals
- Nathalie Clement - VP Vector Development for Translational Gene Therapies, Siren Biotechnology
- Mark Tie - Principal Scientist, Biogen
- Thomas Kelly - Director, Cell Engineering & Analytical Sciences, Johnson & Johnson Innovative Medicine
- Charles Mitchell - Senior Process Scientist, Cell Culture, Visterra Inc
Disposable technology is being used more each year in the biotechnology industry. Disposable bioreactors allow the user to avoid expenses associated with cleaning, assembly and operations, as well as equipment validation. Disposable bioreactors have played a key role to meet the increasing run rate of the Cell Culture Pilot Plant while maintaining a high success rate, reducing labor costs, increasing efficiency, and lowering the risk of contamination. Recent effort to evaluate the next generation 10:1 turndown single use bioreactor with different cell retention devices to challenges oxygen mass transfer, carbon-dioxide stripping while assessing foaming, and vent filter sizing. This presentation will focus primarily on the advantage of the next generation high turndown single use bioreactor that comes with different sparger options (enhanced DHS and mircrosparger), and tubing for different cell retention device connection. Additionally, the high turndown provided a wide range of working volume allowing us to truly test the true scale down of the cell retention device for its maximum flux and filter throughput. The evaluation provided important system performance, operation experience, and cell culture performance data when comparing the next generation high turndown disposable system with respect to the legacy 2:1 and 5:1 turndown single use bioreactors, and conventional stainless-steel bioreactor system.
- Edward Chan - Technical Specialist, Genetech, Inc
- Can scale down models help with implementation?
- Bill Napoli - Principal Engineer, Sanofi
- Sanjay Nilapwar - Principal Scientist I, Purification Development, BioProcess Development, Operations Science & Technology – Biologics, Abbvie
- Dan Bracewell, Ph.D. - Professor, Department of Biochemical Engineering, University College London
Next generation manufacturing through implementation of advanced technologies is one of the current focus areas to enable agile, reliable, cost-effective, and timely production of biopharmaceuticals at highest quality standards. New modalities beyond standard mAB characteristics and complex supply chain logistics in a VUCA environment are factors to consider when designing the plant of the future and will impact the competitive advantage through application of advanced technology concepts. The talk will provide examples of deployment in context with business needs and added value.
- Marcel Tigges - Senior manager, Janssen
Shifting from batch to continuous manufacturing is a promising way of lowering manufacturing costs of by allowing operations to run simultaneously with reduced downtime, higher productivity, and at several-fold smaller scale. This is particularly promising for gene therapy products using recombinant adeno-associated viral vectors (AAV), as treatments currently cost up to USD 3.5 million per patient and have high cost-of-goods ranging up to USD 1 million per dose. In this talk, we present approaches for intensification of downstream AAV manufacturing processes using principles of continuous processing.
- Garima Thakur - Process Development Engineer III, Regeneron Pharmaceuticals
- Bassan Nakhle - Senior Manager, Biogen
- Neeraj Agrawal - Director, Amgen
- Navigating the complex grey area of manufacturing for Phase 1 and 2 trials
- Keeping efficiency while complying with limited guidance
- Need conversation between regulators and developers
- Lessons learnt and case studies from companies moving between clinical phases
- Therapeutic Developer/CDMO dynamics in the phase 1 and beyond
- How to best leverage CDMO expertise and capital efficiency
- Sarah Thomas - Senior Vice President, Quality, REGENXBIO Inc.
- Kathryn Golden - SVP, Technical Operations and Cell Manufacturing, bit.bio
- Kate Rochlin - Chief Operating Officer, IN8bio, USA
- Shankar Swaminathan, PhD - Team Lead, Drug Product Development, CMC-Tech Ops, Astellas Institute for Regenerative Medicine
- What are the key criteria for choosing a cell or gene therapy manufacturing partner? (Expertise, capacity, regulatory knowledge, technology fit)
- Approaching start-up build from the ground up to develop new therapeutics
- Ensuring preparedness for CDMOs
- How can different stakeholders identify complementary strengths to build mutually beneficial partnerships?
- Best practices to ensure quality control and compliance throughout manufacturing.
- Building trust and transparency in long-term CGT manufacturing partnerships
- Amish Patel - SVP, Technical Activity Operations, Calidi Biotherapeutics
- Carolina Alarco - Founder & Principal, Bio Strategy Advisors
- What are the key criteria for choosing a cell or gene therapy manufacturing partner? (Expertise, capacity, regulatory knowledge, technology fit)
- Approaching start-up build from the ground up to develop new therapeutics
- Ensuring preparedness for CDMOs
- How can different stakeholders identify complementary strengths to build mutually beneficial partnerships?
- Best practices to ensure quality control and compliance throughout manufacturing.
- Building trust and transparency in long-term CGT manufacturing partnerships
- Amish Patel - SVP, Technical Activity Operations, Calidi Biotherapeutics
- Carolina Alarco - Founder & Principal, Bio Strategy Advisors