Training Seminars

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

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 follows. 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 industry, including scientific, technical, business, marketing or support functions, who would benefit from a detailed overview of this field.
Sheila Magil, PhD, Vice President, CMC & Quality, Elevation Oncology

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

Sheila Magil has over 40 years of experience in quality and analytical method development for biologics, peptides and small molecules. Her expertise includes quality assurance, protein and peptide biochemistry and analytical development. She was formerly Senior Manager of Analytical Development and Quality Control at Biomeasure, Inc., and previously held positions at Waratah Pharma, Alkermes, Bion and HHMI at Massachusetts General Hospital. Dr. Magil has implemented quality systems and has managed external analytical and QC activities for multiple biopharmaceutical products. Dr. Magil holds a PhD in Biochemistry from the University of Minnesota.

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

Today, leaders in the biopharmaceutical industry are increasingly adopting Quality by Design (QbD), a systematic approach to development that, starting from predefined requirements, emphasizes the understanding of products and processes, as well as the ability to control them. The effectiveness of QbD is evidenced by its wide application in the pharmaceutical field and beyond. The benefits of QbD can be further enhanced by combining this approach with design of experiments (DoE), a method that helps reduce the cost of acquiring new knowledge through statistically designed experiments. This training seminar will present DoE as a tool to support QbD, focusing on the practical application of DoE methods through the use of lectures, JMP statistical software (SAS Institute) and bioprocess case studies.
Marcello Fidaleo, PhD, PEng, Associate Professor, University of Tuscia

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

Marcello Fidaleo is an associate professor at the University of Tuscia (Italy), where he teaches unit operations and design and analysis of experiments for the food and biotechnology industry. He is also a teaching fellow at the Biomanufacturing Training and Education Centre of North Carolina State University (Raleigh, USA) where he teaches a class on DoE for Bioprocess Characterization and Optimization. Marcello has about fifteen years of experience in design of experiments and data modeling in the field of membrane separation, enzymatic, microbial and chemical processes. He is the author of more than 50 scientific papers published on peer reviewed journals and has been a scientific consultant for companies operating in the fields of chemistry, biotechnology and food. Marcello holds a Master of Chemical Engineering from the Sapienza University of Rome and a Doctorate in Food Biotechnology from the University of Tuscia.

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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English


Prelim Agenda Now Available

3月14 - 15日

CELL CULTURE AND BIOPRODUCTION

ADVANCES IN RECOVERY & PURIFICATION

GENE THERAPY CMC AND ANALYTICS

CELL THERAPY MANUFACTURING

ANALYTICS AND CHARACTERIZATION

3月14 - 15日

CELL LINE DEVELOPMENT

INTENSIFIED & CONTINUOUS PROCESSING

GENE THERAPY MANUFACTURING

CELL THERAPY CMC AND ANALYTICS

FORMULATION AND STABILITY