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

• 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
  

INTRODUCTION:

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.

Learning Objectives

• 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.