Overview

Having the knowledge of the underlying biopharmaceutical science is critical for developing viable biopharmaceutical processes for the clinical and commercial manufacturing of biotechnology products. Explore commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion, and adsorptive chromatography.

What You Will Learn

  • Develop biopharmaceutical processes for clinical and commercial manufacturing of biotechnology products
  • Identify key operating parameters for each bioprocess unit operation
  • Decide between available options for single-use technologies in biomanufacturing
  • Strengthen the operational relationship between product, process, and facility attributes 
  • Apply regulatory guidance impacting process development and execution

Course Description and Topics

This 2-day residential training course course provides a comprehensive understanding of biotech manufacturing processes. You will discover the differences between biopharmaceutical processes and small molecules. The course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins. 

The course studies commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion, and adsorptive chromatography.

  • Biotechnology basics
  • Identify and discuss important operating parameters for each bioprocess unit operation and how they impact process performance
  • Discover what parameters are important for process validation
  • Critical factors for developing a viable commercial manufacturing process
  • The attributes of a "good biotech process" for successful manufacturing
  • Process/facility relationships
  • The impact of single-use systems in bioprocesses
  • Additional content will focus on a review of current regulatory guidance impacting process development and execution

Course Modules

  • Introduction
  • Biotech basics
  • Regulatory & QbD
  • Culture of cells and media
  • Filtration processes
  • Viral removal and inactivation
  • Chromatography
  • Single-use
  • Facility and utilities
  • Scale-up

Resources and Activities

  • Pre-Course Work Materials
  • Interactive Exercises
  • Learning Assessments
  • ISPE Guide: Biopharmaceutical Process Development and Manufacturing

Who Should Attend?

  • Individuals with a working knowledge of basic biotechnology and GMP principles, responsible for process design, process validation, and equipment design/selection for biopharmaceutical applications
  • Management, supervisory, and engineering personnel beginning work in biopharmaceutical product development, production operations, quality assurance, and regulatory compliance will benefit from this course. 
  • Anyone who wants to know how biopharmaceutical manufacturing processes work.

Registration Fees 

Price includes 1 nights’ accommodation, dinner, bed and breakfast 

ISPE Member                                                  £ 1,250

ISPE Non-Member                                          £ 1,550

£100 for any extra nights B&B.

All delegates will receive an electronic copy of the ISPE Guide: Biopharmaceutical Process Development and Manufacturing.

To reserve a place, please send an email to NorthEast@ispeuk.org, with the delegate name, email address and company details.