トレーニングセミナー | 17th Annual Bioprocessing Summit 2025 公式サイト

Cambridge Healthtech Instituteのトレーニングセミナーでは、学術的な理論や背景を幅広くカバーするとともに、実際のケーススタディ、遭遇した問題、適用されたソリューションを提供します。各トレーニングセミナーでは、正式な講義とインタラクティブディスカッションやアクティビティを組み合わせて、学習経験を最大限に高めることができます。経験豊富な講師が、現在の研究に適用可能なコンテンツに焦点を当て、この分野に不慣れな人にも重要なガイダンスを提供します。

トレーニングセミナーは、対面のみで提供
一貫性と集中できる学習環境を確保するため、
会議セッションとトレーニングセミナー間の移動は禁止されています。

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.

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.

Instructor:

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.

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