培訓研討會 | 17th Annual Bioprocessing Summit 2025 官方網站

Cambridge Healthtech Institute的培訓研討會提供實際案例研究、遭遇的問題、應用解決方案以及對學術理論和背景的廣泛解釋。每個培訓研討會都結合正式講座與互動討論和活動，以最大限度地提高學習體驗。這些培訓研討會由經驗豐富的講師主持，側重於可應用於當前研究的內容，同時為該領域的新手提供重要指導。

培訓研討會將僅以現場形式舉行
為確保一致和專注的學習環境，
禁止在會議和培訓研討會之間移動。

Monday, August 18, 2025 9:45 am - 3:30 pm | Tuesday, August 19, 2025 8:00 am - 1:00 pm

TS3A: Introduction to Machine Learning for CMC and Biomanufacturing

The aim of this training seminar is to provide an overview and advanced insight into data analytics and modeling methodologies for process data. Fundamental methods to visualize high-dimensional and highly correlated bioprocess and product quality data, to identify the important process drivers as well as to forecast the process and product quality behaviour will be presented in lectures. Hands-on coding and brainstorming sessions will be used to solve case studies from the biopharmaceutical industry. After the course the participants will be aware of relevant techniques and literature for bioprocess data analysis and will be able to evaluate different analysis paths for a given problem.

Introduction to Machine Learning for CMC and Manufacturing

Michael Sokolov, PhD, Lecturer, ETH Zurich; COO and Chairman, Datahow AG

Class highlights:

Learn from more than 10 years of experience on many 100s of process data sets analyzed
Toolbox of key methods for bioprocess data analysis
Introduction to multivariate methods
Introduction to machine learning methods
Introduction to hybrid process modeling
Industrial examples for USP and DSP
Model-based process understanding and design
Model-based process monitoring and control
Transfer learning across molecules and scales
Digital twins

INSTRUCTOR BIOGRAPHIES:

Michael Sokolov, PhD, Lecturer, ETH Zurich; COO and Chairman, Datahow AG

Dr. Michael Sokolov is co-founder and COO of DataHow AG, a spin-off company from ETH Zurich specialized on process data analytics and modeling with a particular focus on the biopharmaceutical and chemical domains. He also holds a lecturer position for statistics for chemical engineers at ETH.

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.

Introduction to Bioprocessing-Discovery to Commercialization

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

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

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.

Wednesday, August 20, 2025 8:00 am - 3:00 pm | Thursday, August 21, 2025 8:00 am - 12:00 pm

TS7B: Formulation, Development, and Manufacturing of Biopharmaceutical Drug Products

This training seminar offers a forum on how to develop sound formulations for biologic drugs, including modern approaches to achieve stable and patient-friendly drug products. The instructor will cover the fundamental knowledge and best practices that will provide the attendee with the necessary tools to be proficient in both the art and science of biopharmaceutical formulation development. Case studies will be presented to demonstrate how to incorporate QbD concepts to do risk assessment, design multivariate experiments, and assess critical quality attributes including subvisible particle characterization in order to develop robust formulation for bulk drug substance or final drug product in the context of designated container closure systems. This course utilizes real-world examples and interactive discussion.

Formulation, Development, and Manufacturing of Biopharmaceutical Drug Products

Danny Chou, PhD, President and Founder, Compassion BioSolution, LLC

Topics to be covered include:

Introduction to the role of formulation development in the biopharmaceutical industry
Mechanisms for physical degradation of proteins and strategies for prevention and management
Mechanisms for chemical degradation of proteins and strategies to prevent chemical degradation in protein formulations
Overview of analytical methods for monitoring protein structure and degradation, including analysis and management of impurities such as sub-visible and visible particles
Biophysical characterization of proteins and its role in protein formulation development
Global strategy for rational development of stable protein formulations
Case studies in biopharmaceutical formulation development, including high/low concentration antibody formulations and delivery device integration to create combination products
The role of advanced technologies in the detection and management of protein aggregation during formulation/device development and bioprocessing
Challenges in the development and manufacture of protein drug products, including strategies for overcoming these challenges
Regulatory aspects of biologics formulation development, including regulatory guidance, process and product impurities, extractables and leachables, and more
Exploration of novel excipients and how to implement these into the regulatory process
Leveraging AI and ML to enhance formulation, stability and delivery methods
Detection, identification, analysis, control, removal, risk assessment and regulation of impurities and Host Cell Proteins (HCPs)
How to apply the concept of DoE and QbD in the development of protein formulations

INSTRUCTOR BIOGRAPHIES:

Danny Chou, PhD, President and Founder, Compassion BioSolution, LLC

Dr. Danny K. Chou is a biopharmaceutical industry veteran with expertise in biopharmaceutical characterization, formulation development, and emerging technologies for protein aggregate/subvisible particle analysis. Currently, Dr. Chou is the Founder and President of Compassion BioSolution, a biopharmaceutical consultancy and Contract Development Service provider that serves clients throughout the world. Dr. Chou has over 20 years of experience in the pharmaceutical industry, both as a pharmacist and pharmaceutical scientist. Over the past 15 years he has led the development of formulations for numerous therapeutic modalities ranging from peptides, growth factors, mAbs, ADCs, and bispecific antibodies. Prior to starting Compassion BioSolution, Dr. Chou was a Senior Scientist and Group Leader at Gilead Sciences, where he successfully built up state-of-the-art analytical capabilities for the company and converted IV formulations of monoclonal antibodies to high concentration formulations that are more stable and can be easily administered by subcutaneous injection. Prior to this, Danny was employed by Genzyme and Amgen, where he played critical roles in drug product process development, manufacturing technical support, and pharmaceutical development. Since founding Compassion BioSolution, Danny has developed stable pharmaceutical dosage form for clients ranging from small start-up biopharmaceutical companies to Fortune 500 pharmaceutical companies. Danny received his PhD from the University of Colorado Center for Pharmaceutical Biotechnology under a NIH Fellowship and his PharmD from the University of Florida.

TS8B: Introduction to CMC for Biological Products: Bioprocessing and Analytical

This 2-day training seminar provides a comprehensive overview of the phase-appropriate CMC activities, quality compliance, and regulatory requirement for developing therapeutic biologics. The curriculum is meticulously designed to cover not only bioprocessing activities such as cell line development, process development, qualification and manufacturing, but also analytical activities such as analytical development, validation, reference standard qualification, rational formulation, specifications, DS/DP release and stability, extended characterization and comparability exercise. Join this interactive training seminar to learn the best practices of CMC activities for the preparation of dossiers. The common CMC pitfalls, queries from health authorities worldwide, and CRL will be exemplified throughout this training class.

Introduction to CMC for Biological Products: Bioprocessing and Analytical

Kevin Zen, PhD, Principal Consultant, Biologics CMC Consulting

Topics to be covered:

Introduction to evolving modality and characteristics of biological products
CMC regulations and guidelines applicable to therapeutic biologics
Quality by design and critical quality attributes (ICH Q8-14)
Overview of manufacturing process of biotherapeutic products
Phase-appropriate CMC activities for IND/IMPD (eCTD 3.2.S, 3.2.P, and 3.2.A)
Raw material, source material and cell banks
Analytical development, qualification, validation, and lifecycle management
Upstream and downstream process development and control strategy
Formulation and final drug product production
Manufacturing process design, characterization, qualification, and lifecycle management
Reference material characterization, certification, and annual qualification
DS/DP specifications, batch/lot release and stability, and expiry assignment
Extended characterization and CMC comparability exercise

Who should attend?

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

INSTRUCTOR BIOGRAPHIES:

Kevin Zen, PhD, Principal Consultant, Biologics CMC Consulting

Kevin is a passionate, committed CMC subject matter expert, developing biologics to help patients and serving biotech community by teaching CMC-related training courses. Kevin has served leadership positions developing therapeutic biological products at AbbVie, AnaptysBio, Catalent Biopharma Solutions (CDMO), IGM Biosciences and Opthea. Kevin not only has in-depth expertise in Analytical Development but also has broad experience in Biologics CMC operation. In the past decades, he has successfully managed many biological drug candidates from early development to commercial. In addition to developing therapeutic biological products in-house, Kevin also had extensive experience working with external CDMO and 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 validation, reference standard qualification, extended characterization, and CMC analytical comparability.

TS9B: Comparability and Potency Assays for Advanced Therapies and Biotherapeutics

Comparability studies following process changes are a critical component of drug development, impacting both CMC (Chemistry, Manufacturing, and Controls) and process development teams significantly. Robust potency assays are crucial not only for these studies but also for process validation and stability testing. This 1.5-day training seminar offers a comprehensive exploration of regulatory science and biological standardization in biologics. The seminar details the nature of potency, highlights the differences in potency assays across biotech and advanced therapies such as cell, gene, and RNA medicines, and discusses the principles of comparability and their varied applications across these modalities.

Comparability and Potency Assays for Advanced Therapies and Biotherapeutics

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

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.

* 活動內容有可能不事先告知作更動及調整。

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