James L. Drinkwater
(Franz Ziel/ PHSS), Head of GMP Compliance, Ex-Chairman PHSS Co-Lead of Annex 1 & CCS
There are an increasing number of ATMPs (Advanced Therapy Medicinal Products) approved as they advance through clinical trials into commercial manufacturing. The challenges in adopting advanced technologies in compliance with GMP requirements are high. At the same time, new regulations intended to support manufacturers taking advantage of the new possibilities presented by these technological advances are coming into force.
This training will cover the challenges of commercialisation in ATMP manufacturing. These include the development, qualification, and implementation of GMP-compliant manufacturing platforms that apply process efficiencies and contamination control measures via integrated technologies (closed process, single-use systems, barrier technologies, and process automation).
One of the drivers in GMP compliance process design is the preparation of a Contamination Control Strategy (CCS) contained in the new EU GMP & PICS Annex 1 requirement. This 2-day training program will explore all design elements (integration of bioburden control and aseptic processing steps), qualification to EU GMP Annex 1 and GMP for ATMPs. as well as implementation case studies. Compliance with the bulk of Annex 1 is expected by August 2023.
The course is limited to no more than 25 people and takes place immediately after the 4th Global Bioprocessing, Bioanalytics and ATMP Manufacturing Congress.
James 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.
Featuring Guest Trainer John Milne from the National Institute of Bioprocessing Research and Training.
Overview of key points in advancing from research into GMP-compliant manufacturing of biologicals and ATMPs including fundamental attributes of ATMP manufacturing platforms.
Regulatory landscape for GMP-compliant manufacturing and key principles: QbD, QRM and Quality metrics.
Process design for commercial scale manufacturing including intensified platforms (integrated technologies) including transition from bioburden control steps into aseptic processing or ‘When the process is the product’ for products that cannot be sterilised by filtration. Includes Case studies.
Preparation of Contamination Control strategies for EU GMP & PICS Annex 1 compliance applied to ATMPs including Gene & Cell therapies and associated vectors.
Skill development via training with ‘Learning by doing’ and NIBRT experience (JM).
Specific aspects of training related to bioprocessing and ATMP manufacturing to meet GMP compliance (JM)
Contamination risks (identified risks) and risk mitigations (control measures that can be applied) in bioprocessing (substance/ vector manufacture) through to Fill & Finish or sterile products. (JLD)
Application of automation and digitalisation in commercial scale manufacturing for process control and process monitoring with data integrity. (JLD).