Training Course: CMC and GMP for Biomanufacturing; Biologics and ATMPs

When

20^th-21^st Nov 2023

Where

Brussels, BELGIUM

Course introduction

This workshop will explore two essential aspects of biomanufacturing: CMC (Chemistry, Manufacturing, and Controls) and GMP (Good Manufacturing Practice). These concepts are crucial for the development and production of biologics and ATMPs (Advanced Therapy Medicinal Products). Compliance with GMP regulations is essential to guarantee the safety, efficacy, and quality of biologics and ATMPs. It helps minimize risks, prevent contamination, and ensure batch-to-batch consistency. GMP guidelines are enforced by regulatory authorities such as the FDA (Food and Drug Administration) in the United States, the EMA (European Medicines Agency) in Europe, and other relevant agencies worldwide. Throughout this workshop, we will delve deeper into CMC and GMP principles, discuss case studies, and explore the latest advancements in biomanufacturing for biologics and ATMPs. We hope this knowledge will empower you to contribute effectively to the field and advance the development of innovative therapies.

About the trainers

Trainer 1: James Drinkwater has been Chairman of the PHSS for 10 years and has honorary membership but recently (during the pandemic years) has taken a more scientific/ technical role as the majority of education has gone online and needs a different ‘marketing/ IT’ skill set to lead the society. The PHSS was one of the EC-appointed commenting platforms in the targeted consultation on Annex 1 revision for the manufacture of sterile medicinal products (that also applies to ATMPs). The PHSS has a strong connection to regulatory authorities, primarily the MHRA UK but also with FDA USA, French, German, Italian, and Danish authorities. It is the Not-for-profit Educational basis that brings this connection.

Currently in the PHSS as a management team member, he has the following lead roles:
• Head of Aseptic processing and Biocontamination special interest group.
• Co-Lead of EU GMP Annex 1 revision focus group
• Co-Lead of focus group preparing guidance on CCS: Contamination control strategies.

Trainer 2: David Murray is as a Subject Matter Expert on the CMC of Biological Medicinal Products and Regulatory Affairs and his role at Parexel involves guiding and advising clients on these aspects at the pre- and post-authorization stages of Clinical Trial and Marketing Authorization procedures.

Prior to joining Parexel in 2021, David worked for 6 years as a Pharmaceutical (CMC/Quality) Assessor of Biological Medicinal Products at the Health Products Regulatory Authority (HPRA) in Ireland. This involved the evaluation of CMC for human biological medicinal products for national and EU procedures. David was a quality assessor as Rapporteur / Co-Rapporteur on new EMA centralized marketing applications and post-authorization variations as well as a coordinator on EMA scientific advice procedures related to the quality aspects for various types of biological products. David frequently delivers lectures to students (University of Copenhagen, University College Cork, Trinity College Dublin, Royal College of Surgeons Ireland) and at conferences as an invited speaker. Prior to joining the HRPA, David developed a strong biomedical research career authoring / co-authoring 40 scientific publications covering a range of biomedical areas including tumour cell biology.

Course Program

PART 1: AN INTRODUCTION TO CMC

The importance of CMC in the development of Biotherapeutics
An overview of the regulatory landscape and guidance available

PART 2: (BIO)CHEMISTRY

Product development, characterisation of the biological active substance, pharmaceutical and formulation development
Container closures and medical devices

PART 3: MANUFACTURING

Process development, raw materials, cell line development
Process validation, control strategy, viral Safety
Process Changes and Comparability

PART 4: CONTROL

Analytical considerations; analytical techniques for QC, characterisation, stability testing
Ref standards, bioassays
Method validation

PART 5: INTRODUCTION TO THE PARADIGM SHIFT IN GMP CONSIDERING

Revised and effective EU GMP Annex 1 and international significance with PICS and WHO versions
Revision of ICHQ9(R1) Quality Risk Management and introduction of ICHQ12; Product life cycle strategies
Update and learnings following Annex1 becoming effective and justifying compliance past the effect date. Complementary GMP requirements: Annex 2, Annex 1 and EU GMP for ATMPs (part4)

PART 6: CONTROL STRATEGIES

Contamination Control Strategy; Annex 1 requirement; case study and learning on implementation
Cross contamination control strategies and applied process solutions
Application of barrier technology, closed and single use systems as primary contamination control measures
Growth in Aseptic processing to support biological products and ATMP manufacturing- key points to consider

PART 7: PROCESS RISK MANAGEMENT

Less subjectivity required in Risk assessment and how to manage; ICHQ9(R1) requirement.
FMECA risk analysis characterized for Criticality in Contamination Control to support CCS preparation and update as a live document
A focus on the PUPSIT risk assessment- key points to consider for compliance.

PART 8: PRINCIPLE GMP CONTAMINATION OF CONTROL MEASURES AND MONITORING

Pressure differential controls, monitoring and deviation response management
Protective airflow; Control, monitoring and qualification visualization: CFDs and smoke studies – best practice

PART 9: FILL AND FINISH OF BIOLOGICAL PRODUCTS AND ATMPS

Case studies at different batch scales and considerations for autologous and allogeneic scale up and commercialization with GMP compliance
Impact of Annex 1 revision on Fill & Finish Aseptic manufacturing
The role and challenges of vaporized hydrogen peroxide as a bio- decontamination method and biological decontamination approach including environmental viral inactivation

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