
Cambridge Healthtech Institute主催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同時に、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ています。各トレーニングセミナーは、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、最大限の学習効果を得られるように設計されています。これらのトレーニングセミナーは、経験豊富な講師陣が、現在の研究に応用できる内容に焦点を当て、その分野を初めて学ぶ方にも有用なガイダンスを提供します。
セミナーは対面式で行われます。
2023年3月14日(火)08:30 - 17:10 | 2023年3月15日(水)08:30 - 10:30
TS1: Introduction to Bioprocessing
TS1: バイオプロセシングの紹介
An Introduction to Biopharmaceuticals and Bioprocessing
- Analytical methods for the characterization and release of biotherapeutics
- Structure-function
- Bioassay
- Higher-order structure
- Phase-appropriate methods
Quality Systems
- Overview
- 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
- Single-use
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
- BLAs/NDAs
INSTRUCTOR BIOGRAPHIES:
Sheila Magil, PhD, Vice President, CMC & Quality, Elevation Oncology
2023年3月15日(水)14:05 - 17:40 | 2023年3月16日(木) 08:30 - 15:20
TS2: Design of Experiments (DOE) for Bioprocess Analysis
TS2: バイオプロセス分析の実験計画法
The aim of this 1.5 day training seminar is to provide attendees with an introduction to the Design of Experiments (DoE) methods applied to the analysis and optimization of bioprocesses to support Quality by Design (QbD) studies. It focuses on the application of DoE methods using lectures, JMP statistical software (SAS Institute, NC), and case studies. The case studies focus on microbial fermentation, chromatography, and pharmaceutical product formulation.
Attendees will receive a practical overview of the following topics: basic statistical concepts for DoE; how to use factorial, fractional factorial, and response surface; how to interpret the output of experimental design software (normal probability, interaction, and contour plots or estimated coefficients tables for factorial or surface response models).
The course is targeted to all those interested in bioprocess development and optimization, particularly those new to DoE techniques, including bioprocess development scientists and engineers, process validation staff interested in defining operating ranges and attribute specifications, and other professionals who want to learn about DoE.
Attendees are invited to bring their own laptops to get hands-on experience with JMP (it is suggested to pre-install a free 30-day trial downloadable online at www.jmp.com), pen, and notepaper.
INSTRUCTOR BIOGRAPHIES:
Marcello Fidaleo, PhD, PEng, Associate Professor, University of Tuscia
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