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、適用された解決策を提供します。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なディスカッションやアクティビティを組み合わせて、学習体験を最大化することができます。トレーニングセミナーは、経験豊富なインストラクターが担当し、現在の研究に応用可能なコンテンツに焦点を当てて、この分野に不慣れな方にも重要なガイダンスを提供します。
2023年8月14日（月） 10:00 am - 3:30 pm | 2023年8月15日（火） 8:00 am - 1:00 pm
TS1: Introduction to Bioprocessing
CHI’s Introduction to Bioprocessing training seminar offers a comprehensive survey of the steps needed to produce today’s complex biopharmaceuticals, from early development through commercial. The seminar begins with a brief introduction to biologic drugs and the aspects of protein science that drive the intricate progression of analytical and process steps that follow. We then step through the stages of bioprocessing, beginning with the development of cell lines and ending at scaling-up for commercial production. The seminar also explores emerging process technologies, facility design considerations, and the regulatory and quality standards that govern our industry throughout development. The important roles of analytical methods at all stages of development as well as formulation and stability assessments in developing and gaining approval for a biopharmaceutical are also examined. This 1.5-day class is directed to attendees working in any aspect of the industry, including scientific, technical, business, marketing, or support functions, who would benefit from a detailed overview of this field.
TOPICS TO BE DISCUSSED:
An Introduction to Biopharmaceuticals and Bioprocessing
Analytical Methods for the Characterization and Release of Biotherapeutics
- Higher-order structure
- Phase-appropriate methods
- Quality by Design (QbD)
- Phase-appropriate quality systems
The Science and Technologies of Bioprocess Unit Operations
Cell Line and Upstream Development
- Expression system selection and development
- Cell banking: Master and working cell bank generation and testing
- Cell culture and fermentation development
- Continuous feed/perfusion/fed-batch
Recovery and Downstream Development
- Affinity capture
- Platform processes
- Purification development strategies
- Polishing and final processing
- Viral clearance validation
Drug Product Development
- Liquid, lyophilized, and other forms
- Formulation development
- Device and packaging considerations
- Combination products
Scaling-Up Drug Substance
- Considerations in scaling-up
- Engineering and first cGMP runs
- Facility considerations
- Tech transfer
Comparability during Scale-Up and after Process Changes
Ready for Late-Stage Development
- Process qualification
- Facility concerns
- Equipment qualification
Ready for Commercial
- What is needed?
- Supply chain considerations
Sheila Magil, PhD, Independent Consultant
Frank Riske, PhD, Managing Director, BioProcess Technology Group, BDO USA, LLP
TS2: Integrating AI and Data Science in the Product 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.
- 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.
Christoph Herwig, PhD, Founder, Lisalis GmbH, former Professor, Bioprocess Engineering, TU Wien
Lukas Marschall, Principal Consultant, Korber
TS3: Introduction to Viral Vectors and Gene Therapy
Targeting disease at its origin, gene therapies offer the promise of a one-time treatment and have transformed how we treat some diseases. These medicines are complex biologics, requiring advanced manufacturing methods and highly skilled operators. This training session will provide an expansive introduction to the area of gene therapy, the manufacture of these complex biologics, the facilities, equipment and personnel needed to produce them, and the analytical and quality aspects surrounding them.
The session will cover but not be limited to:
- Viral and non-viral vectors
- Gene Editing
- Manufacturing methods and processes
- Facility design
Scott Cross, Senior Principal, Dark Horse Consulting Group
2023年8月16日（水） 8:00 am - 3:00 pm | 2023年8月17日（木） 8:00 am - 12:00 pm
TS4: Potency Assays and Comparability for Cell and Gene Therapies
The evaluation of potency plays a key role in defining the quality of cellular and gene therapy products. CHI's Training Seminar, Potency Assays and Comparability for Cell and Gene Therapy, provides an insight into the expectations and challenges in development of potency assays specific for cell and gene therapies; several real-life experiences from the industry are presented as illustrations, including the impact of comparability assessment following process change.
Christopher Bravery, PhD, Consulting Regulatory Scientist, Advanced Biologicals Ltd.
TS5: Introduction to CMC for Biotech, Cell & Gene Therapy Products
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.
Kevin Zen, PhD, Senior Director, IGM Biosciences