Training Seminars

本會議的培訓研討會將廣泛討論學術理論及其背景,並提供實際案例、面臨的挑戰和應用的解決方案。為了最大程度地提升學習體驗,每個研討會都結合了正式講座、互動討論和活動。在經驗豐富的講師指導下,配合可應用在當前研究上的熱門內容,為還不太熟悉該領域的與會者們提供重要支援。

 

培訓研討會僅以面對面形式舉行。

2024年8月19日(一)  10:00 am - 3:30 pm |  2024年8月20日(二)  8:00 am - 1:00 pm

TS8A: Introduction to Alternative Protein Production

This training seminar will provide a comprehensive introduction to alternative protein production, with an emphasis on cultivated meat and precision fermentation. We will cover production fundamentals in this emerging bioprocessing space and highlight the state of science and technology. The objective of this course is to provide bioprocess scientists with backgrounds in biotherapeutics with an orientation to the alternative protein space to expand their options for technology collaborations and career opportunities.
  • Introduction to the alternative protein industry 
  • An overview of alternative protein production (cultivated meat, precision fermentation, plant molecular farming) 
  • Alternative protein upstream: cell lines & cell culture 
  • Alternative protein downstream: purification & recovery 
  • Genetic engineering and synthetic biology in alternative protein 
  • Alternative protein scale-up challenges and solutions 
  • Techno-economic analysis of cultivated meat and precision fermentation 
  • Case studies in cultivated meat and precision fermentation 
  • Future directions and technological innovations for alternative protein 
  • Translating a biopharma bioprocessing skillset into the alternative proteins space 
  • Opportunities to engage with the alternative protein community

INSTRUCTOR BIOGRAPHIES:

Matt McNulty, PhD, Associate Director, Tufts University Center for Cellular Agriculture

Matt is the Associate Director for the Tufts University Center for Cellular Agriculture (TUCCA), a top-in-class institute in the emerging field of cellular agriculture, in which agricultural goods typically procured by means of animal husbandry are instead produced via cell culture - with TUCCA specializing in cultivated meat and precision fermentation approaches to alternative proteins. Matt is committed to advancing innovative and sustainable biotechnical solutions to food insecurity, public health risks, and climate change challenges. He leverages a foundation in industrial bioprocessing to approach alternative protein education and research from a systems-oriented focus on commercialization bottlenecks. His professional experiences include upstream biologics process engineering at Sanofi, biopharma operations analysis and change management consulting at N-SIDE, and a Research Fellowship investigating cultivated meat research whitespaces at the Good Food Institute. Matt has authored +15 publications and holds a PhD in chemical engineering from UC Davis, where he focused on plant-based protein production for biopharmaceutical and food applications.

TS9A: Introduction to Bioprocessing - Discovery to Commercialization

The seminar will introduce participants to bioprocessing from a process development, manufacturing and regulatory perspective. The seminar will follow a “molecule” from discovery to commercialization that is produced using mammalian cell culture and the different unit operations will be introduced as well as CMC considerations. In addition, different modalities will be explored with regards to opportunities and challenges in development and production methods such as production of Advanced Therapies (Cell and Gene Therapies). In addition, data and its analysis is a critical component to ensure process understanding and minimize CMC challenges and best practices for data management and new statistical methods and tools will be introduced.

Topics to be covered: 

  • Upstream Bioprocessing: Mammalian Expression Systems
  • Downstream/Purification Bioprocessing
  • Scale-Up and Scale-Down Considerations
  • Chemistry, Manufacturing, and Control (CMC) Pathway, and Program Design Considerations
  • Overview and Considerations for Development and Manufacturing of Advanced Therapies: Cell and Gene
  • Avoiding Data Lakes and Leveraging New Methods for Data Analysis Using Modern DoE and Prediction
  • Next-Generation Processes: Continuous Manufacturing, etc.

Who Should Attend:

  • Bioprocessing Scientists and Engineers in Process Development, Research and Development, Manufacturing Science. CMC, Quality Assurance, etc.

INSTRUCTOR BIOGRAPHIES:

Martin Hurley, Managing Director, BioPharma Technical Consulting (BPTC)

Martin Hurley is the director and co-founder of Bio Pharma Technical Consulting, a consultancy that partners with clients to deliver expertise in CMC, Cell & Gene Therapy, Tech Transfer, GAMP5 in the Biopharma and Pharma space. He brings 30+ years of international Automation, System development (SCADA), and PM experience in electronics, pharma industries. Prior to establishing BPTC, Martin was Applications Systems Manager EMEA with Elanco Animal Health (a division of Eli Lilly until 2019) where he liaised with scientists and equipment vendors to develop and deliver high-end enzyme application systems and solutions. Martin also worked with Eli Lilly in the Caribbean Island of Puerto Rico where, as a member of the Capacity Expansion Team, he managed business critical projects involving application of lean strategies to optimize CSV processes to meet or exceed regulatory expectations. Previous roles include software engineering in the electronics industry (Apple Computer) and SCADA development/deployment (Gilroy Automation) for clients in the Pharma industry. In Summary: Martin is analytical and strategy-oriented, with experience in large-scale multiphase and high-profile projects in a variety of areas including automation, equipment deployment and capacity expansions in a GMP environment.

Tiffany D. Rau, PhD, Owner, Rau Consulting LLC

Tiffany D Rau, Ph.D., Owner and Principal Consultant of Rau Consulting and is an expert in bio processing and a Six Sigma Master Black Belt. Her international technical and managerial experience extends from development to post-commercial cGMP manufacturing. Dr. Rau has been instrumental in designing and leading initiatives to bring R&D and manufacturing together to increase speed to market and minimize technology transfer challenges. Dr. Rau has been the advisor on over 100 different projects in the areas of process intensification, scale-up, variability reduction, and continuous improvement for both mammalian and microbial expression systems. Previously, Dr. Rau has held leadership positions at Evonik-Degussa, Eli Lilly, Pall and GlaxoSmithKline all focused in process development, tech transfer, commercial manufacturing, and CMC strategy. Dr. Rau has over 75 invited speaking engagements focused on delivering current and next-generation products from R and D to commercialization/post-commercialization. Tiffany is also active in the scientific community and is Program Chair for the Recent Advances in Fermentation Technology meeting (2015-2019) and has organized numerous sessions at the SIMB National Meetings (Society of Industrial Microbiology and Biotechnology) and ECI Cell Culture Engineering meetings. She was also part of the inaugural organizing team for ECI’s Microbial Engineering Conference in 2018 and continued on the organizing committee for 2020.

TS10A: Holistic Data Management and Digital Twins for the Bioprocess Life Cycle

Regulatory expectations for statistically underpinned Process Validation (PV) have found their way into current guidelines leading to demonstrating Established Conditions (ECs) in ICH Q12. However, successful and accelerated biopharmaceutical process validation (Stage 1-3) remains unresolved in industrial practice. This is due to the necessity of using scale-down models, the cost-intensive setup of experiments, and the complexity due to the interactivity of a multitude of unit operations. The commonly accepted hypothesis is that sound data science and digital twin approaches will be a success factor in this endeavor.

This training seminar will focus on:

  • Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool PAS-X Savvy.
  • Methods and best practices embedded in workflows based on data science and digital twins, using case studies and hands-on exercises. Designed for the biopharmaceutical and industrial biotech industry.
  • Contemporary and novel approaches to accelerate process development, efficiently gaining CMC process understanding for meeting Stage 1 Validation expectations.
Learning Objectives:
  • Understand regulatory perspectives on challenges and concerns in bioprocess validation.
  • Gain insights into new tools and workflows to target critical components towards a successful bioprocess stage 1 validation and technology transfer.
  • Gain hands on experience in solving challenges for bioprocess validation, such as scale down model qualification, experimental design & evaluation, as well as setting up a control strategy.
  • Understand challenges in process validation life cycle. Explore challenges and emerging solutions in process validation for current and next generation bioproducts.
  • See the potential of digital twins for accelerating the product life cycle and increase process robustness.
  • Participate in demonstrated application through review of multiple case studies.

INSTRUCTOR BIOGRAPHIES:

Christoph Herwig, PhD, former Professor, Bioprocess Engineering, Vienna University of Technology; CPO, Fermify GmbH; Senior Scientific Advisor, Korber Pharma Austria

Christoph Herwig, bioprocess engineer from RWTH Aachen and obtained a PhD in bioprocess identification at EPFL, Switzerland. From 2008 to 2023, he was full professor for biochemical engineering at the Vienna University of Technology. The research area focused on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. During his employments in various industries, such as with Lonza, he was deeply involved in the design and commissioning of large chemical and biopharmaceutical facilities. In 2013 he founded the company Exputec, which is now part of Korber Pharma, pioneering data science software solutions for the biopharma life cycle. Here, Christoph currently also acts as senior scientific advisor for Korber. In 2021 he cofounded Fermify and acts as CPO, focusing on providing a fully digitalized production platform for vegan cheese.

Sherwin Jayashinghe, Technical Sales Engineer, Koerber Pharma Software

Sherwin Jayasinghe is a Technical Sales Engineer for Koerber Pharma Software. In this role, Sherwin has presented technical demonstrations of PAS-X Savvy to potential clients that are interested in the capabilities of the software. He is a graduate of Rutgers University-New Brunswick with a Master's in Information Science with a concentration in Data Science.

2024年8月21日(三)  8:00 am - 3:00 pm |  2024年8月22日(四)  8:00 am - 12:00 pm

TS8B: Introduction to Machine Learning and Artificial Intelligence for Bioprocessing Applications

What does it take to be AI ready? Join us for an interactive 1.5-day training where we examine how to implement generative AI, large language models, and machine learning tools for a bioprocessing organization. We’ll define proper use case requirements, explore the necessary components of data integrity, and outline how to go from a proof-of-concept to the deployment of a production level solution. Join us as we play games, compete for prizes, and learn what it means to create a truly fit for purpose digital solution.
  • Recent advancements in AI technology
  • Use cases in bioprocessing
  • “Good data”-how do scientists and data scientists define that differently
  • Data standardization
  • Create well defined data
  • Ensure your dataset is representative
  • Communicating clear use case requirements
  • Choosing the right tool or model
  • Data cleansing-what is it and why does it always take so long
  • Data security and what that means for bringing in new technology
  • How to go from proof-of-concept to production

INSTRUCTOR BIOGRAPHIES:

Avinash Dalal, Director of Data Science, Lumilytics

Avinash Dalal Ph.D. is director of data science at Lumilytics. His team works to build fit for purpose solutions for pharmaceutical drug development by applying generative AI and computational modeling. Prior to Lumilytics, Avi worked as a principal data scientist leading development and deployment of AI and modeling solutions in biotherapeutics at Pfizer. Prior to joining Pfizer, he worked in forecasting for the retail market and was also a tenure-track professor in mathematics & statistics. He has his Ph.D. in mathematics from Drexel University where his work was in algebraic combinatorics and geometry.

Varsha Daswani, PhD, PMP, Senior Director, Data Strategy, Lumilytics

Varsha Daswani Ph.D. PMP is the senior director of data strategy at Lumilytics. Her team works to adapt and advance generative AI, natural language processing, and machine learning tools to create fit for purpose solutions for pharmaceutical drug development. Prior to joining Lumilytics, Varsha worked at both Pfizer and Janssen. Most recently at Pfizer, she led the large molecule Analytics and Data Science group. She has her Ph.D. in Biochemistry from Temple University where she developed a novel liposome encapsulation method for small molecule chemotherapeutic agents.

TS9B: Comparability and Potency Assays for Cell, Gene and Biotech Products

Comparability studies following process change is an inevitable part of drug development, but with wide ramifications for CMC and process development departments alike. Robust potency assays are fundamental also for comparability studies, process validation, and for stability testing. CHI's 1.5-day training seminar, Comparability and Potency Assays for Cell, Gene Therapy and Biotech products provides an in-depth look at the application of regulatory science and biological standardization to biological products; what is potency, and how potency assays differ between biotech and cell and gene therapy products; plus principles of comparability and how their application differs between biotech, cell, and gene therapy products.

INSTRUCTOR BIOGRAPHIES:

Christopher Bravery, PhD, Consulting Regulatory Scientist, Advanced Biologicals Ltd.

Christopher founded Consulting on Advanced Biologicals Ltd. at the end of 2009, in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd. provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd., a Novartis Pharma AG Co., and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time, Christopher was involved with national implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

TS10B: Cost and Sustainability Analysis through Modeling

Optimizing biomanufacturing processes in today's fast-paced world is more critical than ever. Applying process cost and sustainability modeling can help you achieve this goal, saving time and money while reducing your environmental impact. This course is tailored to meet the needs of professionals in process development, tech transfer, and facility process improvement. The course will provide an introduction to predicting the impact of process and technology options on sustainability (Process Mass Intensity, Water, Energy) and economic outcomes (Cost of Goods COGS, Capital). They are illustrated by practical examples and hands-on anonymized case studies based on mAbs and AAVs. The course will provide access to a modelling toolset and the latest optimization methods based on Bayesian machine learning applicable to bioprocessing evaluating, for example, intensification options, continuous operation, single-use technologies, etc. Leveraging these powerful tools leads to better process understanding and identifies often overlooked areas for improvement.

Agenda:

  • Industry trends and dynamics on manufacturing costs and sustainability: why does it matter
  • What is the COGS in bioprocessing; fixed costs (capital) vs. variable (operating) and the importance of cash flow
  • What is sustainability, and how do we measure and predict performance? Essential factors to consider relating to process, the facility, and location.
  • Using process models to predict CoG & sustainability KPIs, the critical cost drivers and the points to consider.
  • Predicting the impact of scale, technology and process intensification options on cost and economics
  • Sensitivity analysis and optimization-understanding trade-offs between economics and sustainability
  • Framing requirements and minimizing risk using modeling. Accounting for stage in development, level of uncertainty, new build or retrofit, etc. 
  • Applications in process development, facility design, tech transfer

Who Should Attend?

  • Process Development Scientist
  • Process Engineer
  • Process Technology Manager or Process Owner
  • Technical Lead
  • Director, Drug Subtance or Technical Operations
  • CMC Technical Project Manager
  • CMC Consultant
  • Sustainability Lead

INSTRUCTOR BIOGRAPHIES:

Ken Hamilton, Distinguished Engineer, Genentech

Ken Hamilton is a chemical engineer with over 30 years' experience. He has a Master's and Ph.D. from University of Wales and undergraduate at University of Manchester Science & Technology, in the UK. His background includes process and facility design and engineering and leading projects to enable drug substance manufacturing sites to receive new products and platforms. He also undertakes process economic analyses for new processes. He is a Distinguished Engineer at Roche/Genentech, in their global technology organization, and has been at Roche/Genentech for the past 18 years. Responsibilities include leading evaluations of new process platforms and new equipment technologies for manufacturability and cost, working closely with R&D, Finance, business strategy groups and the drug substance manufacturing sites. Previously, he led the process-engineering group at one of the drug substance sites, supporting ongoing manufacturing operations and the engineering aspects of product transfers to the site. He was chapter president of the ISPE San Diego chapter, and is a co-lead for the NIIMBL Sustainability team. Several years ago, he was an affiliate professor at Colorado State University. Ken has made roughly 20 presentations and publications to the biopharm industry.

Andrew Sinclair, MSc, CEng, FIChemE, FREng, President & Founder, BioPharm Services Ltd.

Andrew has over 30 years’ design and operational experience in the biopharmaceutical industry, with direct responsibility for manufacturing, logistics, maintenance and capital programme management. He has developed Biopharm Services into a leading provider of bioprocess modelling and knowledge management tools that support bioprocess innovation. The focus of his work is in the understanding the impact of innovative technologies on biomanufacturing with focus on single use systems and continuous processing. Prior to Biopharm Services, Andrew was Director of Engineering and Logistics at Lonza Biologics and holds an MSc in Biochemical Engineering from UCL. He was a finalist in “The Manufacturing Processing Thought Leader of the Decade” category at the 2012 BioProcess International Awards and in 2014 was appointed a Fellow of the Royal Academy of Engineering in the UK.

John Welsh, Principal Consultant, Rivanna Bioprocess Solutions LLC

John Welsh is the Principal Consultant at Rivanna Bioprocess Solutions LLC, an independent consultancy that provides CMC and process development services for biotherapeutic companies. He previously worked at Merck & Co., Inc. for over 11 years in bioprocess purification development where he supported preclinical and clinical candidates in process development and characterization activities. He also led a high-throughput chromatography screening lab and has expertise in chromatographic separations, process modeling, and continuous manufacturing. John holds a Ph.D. in Chemical Engineering from Stanford University where he worked under James Swartz's tutelage to better understand and apply cell-free protein synthesis technologies. He is a co-author on a number of peer-reviewed papers from both academic and industrial studies.

TS11B: Introduction to CMC for Biotech, Cell & Gene Therapy Products

This interactive course will provide a comprehensive CMC overview of therapeutic biological products. It introduces a variety of therapeutic modalities including recombinant proteins, Mab and cell and gene therapy in the context of IMPD and IND regulatory filing. You will learn scientific, technical, and operational aspects of overall biologics CMC activities as well as quality compliance and regulatory requirements. The instructor will present common pitfalls and share the best industry practices.

The chemistry manufacturing and controls (CMC) of biologics is a multidiscipline technical operation of bioprocess, analytics, dosage formulation, and cGMP manufacturing/testing for DS/DP release and stability to treat human diseases. This interactive training course will provide a comprehensive CMC overview of therapeutic biological products. It introduces a variety of therapeutic modalities including recombinant proteins, monoclonal antibodies (Mab), and cell and gene therapy (CGT) in the context of IMPD and IND regulatory filing. Attendees will learn scientific, technical, and operational aspects of overall biologics CMC activities as well as quality compliance and regulatory requirements. The instructor will present common pitfalls and share the best industry practices. Numerous real-world regulatory queries/comments from health authorities worldwide will be exemplified as case studies during the training course.


TOPICS TO BE COVERED:

1. Diverse modality of therapeutic biological products 

2. Biologics CMC activities for regulatory filing (IMPD/IND)

3. Quality by design (QbD) concept, quality target product profile (QTPP), and critical quality attributes (CQA) 

4. Cell line development, process development, and manufacture of biologics, CGT DS and DP

5. Current analytical technologies to characterize product variants/impurities, process impurities (e.g., HCP), and contaminants

6. Formulation development and compatibility with container closures and injection devices 

7. Reference material characterization/qualification and justification of specifications for DS/DP release and ICH stability for product expiry

8. Process validation, analytical validation, and control strategy of cGMP manufacturing 

9. Manufacturing process changes during product development lifecycle: CMC comparability exercise

WHO SHOULD ATTEND: 

The course is beneficial to individuals involved in biologics drug research/development, bioprocess development, analytical development, formulation development, quality control, quality assurance, regulatory affairs, project management, or related functional areas.

INSTRUCTOR BIOGRAPHIES:

Kevin Zen, PhD, Senior Director, IGM Biosciences

Kevin has over 20 years of broad experience in Biologics CMC, and Strategic and Technical Operations. Prior to joining IGM Biosciences, he held various positions in biologics CMC disciplines at Allergan, AnaptysBio, AstraZeneca, Becton Dickinson, and Catalent Biopharma Solutions. In addition to developing therapeutic biological products in-house, Kevin also had extensive experience working with external contract manufacturing organizations (CMO) and contract research organizations (CRO), including production cell line development, bioprocess development, DS/DP cGMP manufacturing, process characterization, process performance qualification (PPQ), formulation development by DoE, analytical procedure development and method validation, reference standard qualification, extended characterization, and CMC analytical comparability.

* 活動內容有可能不事先告知作更動及調整。

Choose your language
Chinese
Japanese
Korean
English