培训研讨会 | 18th Annual Bioprocessing Summit 2026 官方网站

Monday, August 10, 2026 8:30 am - 4:20 pm

TS2A: 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.

Topics to be covered include:

Introduction to the role of protein 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
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
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, and more

INSTRUCTOR BIOGRAPHY:

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.

TS3A: Introduction to Machine Learning for CMC and Biomanufacturing

This training seminar aims 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, will be presented. These methods will help to identify the important process drivers as well as to forecast the process and product quality behavior. Hands-on coding and brainstorming sessions will be used to solve case studies from the biopharmaceutical industry.

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 BIOGRAPHY:

Claus Wirnsperger, Senior Machine Learning Engineer, DataHow AG

Claus Wirnsperger is a Senior Machine Learning Engineer at DataHow AG in Zürich, where he leads research and development of novel algorithms for biopharmaceutical data analytics and architects scalable data transformation microservices using Python, Rust, and Golang orchestrated by Kubernetes. With experience supporting the digital transformation of production facilities for many of the world’s largest pharmaceutical companies, he has a strong background in time-series forecasting, optimization, and control, as well as the development of ML tools and SDKs. Before joining industry, Claus conducted research at ETH Zürich, applying variational autoencoders to detect exoplanets in large infrared image datasets. He holds both a Master’s and Bachelor’s degree in Physics from ETH Zürich, specializing in machine learning and astrophysics.

TS4A: Introduction to CMC for Biotherapeutic Products: Bioprocessing and Analytical

This 1-day training seminar provides a comprehensive overview of the phase-appropriate CMC activities for biotherapeutic products and introduces the brand new CTD Quality guidance (2026). 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, QC release and stability, extended characterization and comparability exercise. Join this interactive educational class to learn how to execute CMC activities and how to prepare eCTD Module 2.3 and Module 3 Quality for regulatory submission. The common CMC pitfalls, queries from health authorities worldwide, and Complete Response Letters (CRLs) will be exemplified throughout this training class.

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 (CQAs)
Overview of manufacturing process of biotherapeutic products
Phase-appropriate CMC regulatory submission for IND/IMPD
Raw material, source material and production cell banks
Analytical development, qualification, validation, and lifecycle management
Upstream and downstream process development and control strategy
Formulation and final drug product fill/finish
Process Vvalidation: process design, characterization, qualification, and lifecycle management
Reference material generation, characterization, certification, and annual qualification
DS/DP specifications/justifications, 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 BIOGRAPHY:

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.