An Overview of Biopharmaceutical Manufacturing Processes (T24) Training Course

Overview

Having the foundational 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

Resources and Activities

ISPE Guide Biopharmaceutical Process Development and Manufacturing

2-Day Classroom Course Modules

  • Introduction
  • Biotech Basics
  • Regulatory & QbD
  • Culture of Cells & Media
  • Filtration processes
  • Viral Removal and Inactivation
  • Chromatography
  • Single-use
  • Facility and Utilities
  • Scale-up

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
  • Anyone who wants to know how biopharmaceutical manufacturing processes work

2-Day Classroom Course Additional Details

This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. 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. Course topics include:

Biotechnology basics

  • Identify and discuss important operating parameters for each bioprocess unit operation and how they impact process performance
  • 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.

Communities of Practice

This training course is of particular interest to existing and future members of the ISPE Biotechnology  Community of Practice.

Registration Fees

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

  • ISPE Member                                                     £ 950
  • ISPE Non-Member                                         £ 1,500
  • Emerging Leader ISPE Member                     £ 750   
  • Emerging Leader ISPE Non-Member          £ 1,200                

All delegates will receive an electronic download 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
  • ISPE Membership Number
  • Delegate’s dietary requirements
  • Company name
  • Telephone number
  • Purchase order number
  • Invoice email address

Instructor

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, leading all audits.

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.