Overview

Understanding the intricacies of biopharmaceutical science is paramount for developing effective processes in both clinical and commercial manufacturing. By attending this course, you will gain an understanding of the critical manufacturing operations, including cell culture and fermentation, harvest and recovery, viral removal and inactivation, and purification processes like tangential flow filtration, centrifugation, size exclusion, and adsorptive chromatography.

What You Will Learn:

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

Over two intensive days, you'll gain a comprehensive understanding of biotech manufacturing processes, including a comparison with small molecules. Our curriculum covers the underlying principles of proteins and cells, providing a solid foundation for understanding therapeutic protein manufacturing. 

Key topics include:

  • Biotechnology basics
  • Operating parameters and process validation
  • Critical factors for developing commercial manufacturing processes
  • Single-use systems and their impact
  • Regulatory guidance and execution

2-Day Course Modules

  • Introduction
  • Biotech basics
  • Regulatory & Quality by Design (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 

A buffet lunch and refreshments will be provided each day. The price also includes 1 night’s accommodation, dinner, bed and breakfast. 

ISPE Membern>                                              £ 950

Emerging Leader ISPE Member                  £ 750    

ISPE Non-Member                                      £ 1,500

Emerging Leader ISPE Non-Member       £ 1,200

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

Price includes one year’s ISPE membership for non-members.

Reserve Your Place

To reserve your place on the course please email the following details to NorthEast@ispeuk.org

  • Delegate’s name
  • Delegate’s email address
  • Delegate’s ISPE membership number 
  • Delegate’s dietary requirements
  • Company name
  • Telephone number
  • Purchase order number

Peter W. Dodd

Dr. Peter Dodd, an approved ISPE trainer, commenced his career in Chemical Engineering at ICI Billingham, where he served as the last Fermentation Engineer overseeing the world's largest fermenter, which operated continuously for months necessitating meticulous sterile engineering. He played a pivotal role in pioneering the world's first continuous GMO product and served as a technical leader in the manufacture of microbial and plant-based bioplastics. Notably, he spearheaded the startup of Fujifilm Diosynth's commercial-scale microbial biopharmaceutical facility and held various key positions such as Head of Manufacturing, Head of Commercial QA, and Site Director for Fujifilm's Billingham site.

His expertise extends to Business Development, Mammalian Plant Qualification, and extensive experience as Gold Command for Site Emergencies. Predominantly, he focused on process development, successfully scaling up and transferring numerous biopharmaceutical processes. Post-retirement, he facilitated the tech transfer of the AstraZeneca Covid-19 vaccine to a different continent and played a crucial role in ISPE UK's Covid-19 response efforts.

Peter has been an active member of ISPE for over two decades, serving as the UK Affiliate Chair from 2015 to 2017 and as Co-Chair from 2022 to 2024. Leveraging his wealth of experience, gained over 32 years at Fujifilm's Billingham site, he has embraced the role of ISPE UK Affiliate's training coordinator, dedicated to imparting his pharmaceutical expertise to the next generation.