Event Type: Industry Conference | Date: September 11, 2018- September 11, 2018 | Location: Wilkins Building, UCL Gower Street, London WC1E 6HJ

9:15am - 4:30pm (GMT)

This major PHSS conference, in association with UCL Q3P, will address the key challenges in manufacturing and aseptic processing of Biological and Advanced Medicinal Therapeutic products (ATMPs) considering challenges in GMP compliance and application of Quality Risk management.

New ATMP therapies present new challenges in aseptic processing, contamination and cross contamination control at many different scales of processing. A case study will be presented for an ATMP product with a viral vector to consider the pathway and GMP challenges from development to commercial scale up. Biological products are now coming through development, formulation and scale-up progression into aseptic manufacturing.

Many new products are starting at small scale moving into aseptic manufacturing with the challenge of connecting science/ scientists and GMP. A case study presents the key challenges and how such challenges are addressed with increasing GMP knowledge and risk mitigation in aseptic manufacturing. Aseptic-Containment is developing where high containment is required for new products types, including ADCs, because they present risks to operators down to new OEB6 (Nano gram) levels or have cross contamination challenges in a facility or between products manufactured in the same facility.

Containment also connects non-sterile API processing to sterile toxic aseptic manufacturing. A new PHSS Containment initiative will be presented to consider such developing requirements and what ‘gaps’ exist in current knowledge, technology, qualification methodology and methods. For many it is unclear how the GMP for ATMPs and revised Annex 1 requirements will fit together and how QRM can be applied to cover areas that are still outside general GMP guidance. This conference will explore the relationship between the GMP for ATMPs and revised Annex 1 together with regulatory expectations. Probiotics as therapies are starting to be characterised as microbiome therapies and further challenge GMP regulations. A new microbiome therapy development will be presented with an overview of challenges that have been faced towards regulatory compliance and alignment as microbiome therapies connect to clinical study and understanding of interaction with the human microbiome.

Programme: Challenges in biological product and ATMP aseptic manufacturing and processing with applied QRM principles and GMP compliance.

     9.15am: PHSS & UCL Q3P Welcome and overview of conference sessions. Conference Chairperson Jenni Tranter Steris corporation: Vice Chair of PHSS.
     9.30am – 10.30am: Key note presentation: GMP inspector’s point of view: GMP for ATMPs and connection to EU GMP Annex 1. The GMP for ATMPs was widely commented on and considered to have some challenges but has now released as a standalone GMP for ATMPs. As a standalone GMP the connection with EU GMP Annex 1 (existing and coming revision) is not clear. The MHRA speaker will provide a GMP inspector’s point of view on the new ATMP GMP and relationship to Annex 1. MHRA Speaker: either Ian Rees or Andrew Hopkins.
     10.30am – 11.15am: Microbiome therapies and regulatory issues surrounding the development of this field. This new area of therapy development challenges existing regulations in sterile/ therapeutic product manufacturing but opens up a new field of interaction with the human micro biome and possible patient benefits. Speaker: Prof. Shahram Lavasani, CEO Immune Biotech AB.
     11.15am – 12.00pm: Coffee and viewing exhibition.
     12.00pm – 12.45pm: A case study and learning through the development and aseptic manufacture of a viral vector used in a ATMP cancer therapy. Speaker: Matthew G. Ryan Oxford Biomedica; Head of Quality & Qualified Person (QP) (under 2001/83/EC permanent provisions).
     12.45pm – 1.45pm: Lunch and viewing exhibition & networking.
     1.45pm – 2.30pm: Small scale biological product aseptic manufacturing considering ‘Connecting science/ scientists and GMP’. Speaker: TBC.
     2.30pm – 3.00pm: Q&A.
     3.00pm – 3.30pm: Coffee/Tea break in exhibition area.
     3.30pm – 4.15pm: Containment and GMP. This presentation considers the challenges, current positions and gaps in requirements for containment through nonsterile API processing into Aseptic – Containment in filling of hazardous/ toxic products of high potency and toxicity considering containment at Nano-gram/ OEB 6 levels where Health based exposures levels (HBELs) apply. Speakers (Joint presentation) from leaders of PHSS Containment special interest group: Colin Newbould, Wasdell Group: Director of Regulatory Affairs and QP Services: Non sterile product / API processing perspective. James Drinkwater, F Ziel Head of GMP Compliance & Aseptic processing support. Chairman of PHSS. Sterile product aseptic manufacturing perspective.
     4.15pm: PHSS Chairman’s thanks and Vice Chair closing remarks.

An Exhibition is included with exhibitors who can provide further knowledge and support with technologies and essential supplies/ services in sterile biological product aseptic manufacturing and ATMP therapy processing following QRM principles and GMP compliance. Attendance is free of charge to PHSS members as a member benefit. Non members can join or pay an attendance fee equal to the PHSS membership fee.

PHSS: Pharmaceutical and Healthcare Sciences Society

Tel: +44 (0) 1793 824254