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PHSS & UCL Q3P Annual Conference 2020
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PHSS & UCL Q3P Annual Conference 2020

Challenges in Biological & Advanced Medicinal Therapeutic product( ATMP) manufacturing following GMP Compliance

 Export to Your Calendar 17/09/2020
When: Thursday, September 17th September 2020
9:00 AM
Where: Map this event »
School of Pharmacy, UCL
29-39 Brunswick Square
London WC1N 1AX
United Kingdom
Contact: Tamsin Marshall
01793824254


Online registration is available until: 11/09/2020
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PHSS-UCL Q3P ANNUAL CONFERENCE, 17 September 2020, UCL, London UK 

 

 

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. We are pleased to announce this year we are returning to the School of Pharmacy, Brunswick Square.

 

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.  

 

Programme - Challenges in Biological and Advanced Medicinal Therapeutic product ATMP manufacturing with GMP compliance

 

8.30 Registration and viewing of exhibition.

 

9.00 Welcome and opening remarks: PHSS Chair - Jenni Tranter.

 

9.10 Welcome from Q3P Dr Khalid Ahmad Sheikh, Course Director

 

9.15 Students Awards

 

9.20 – 10.05 MHRA regulatory observations and expectations in processing Biological and ATMPs: MHRA

 

10.05 -10.50 Simon Simpkins, Vice President & Head of Manufacturing

Developing a robust supply chain for the supply of commercial viral vectors for use in cell and gene therapies

·         Management and oversight of suppliers and service providers of critical starting materials and GMP services

·         Continuous improvement of manufacturing processes to de-risk the supply chain

·         Scale-up and/or scale out to support demand

·         Capacity expansion and development

·         Contingency and cross validating sites

 

10.50 – 11.20 Exhibition and networking break.

 

11.20 – 12.05 Stuart Curbishley, Head of Business and Process Development for ATMP’s (University of Birmingham)- Manufacturing ATMPs in an academic centre

 

12.05 -12.50 Sean Russell, Director of Regulatory Affairs, Achilles Therapeutics  

 

12.50 – 13.50. Lunch and Exhibition

 

13.50-14.35: TBC

 

14.35-15.15 Exhibition and networking break

 

15.15-16.00 SIG summary and update, James Drinkwater Head of PHSS Biocontamination and Aseptic Special Interests group. Clarity of GMP guidance Update

 

16.00: Thanks and close, PHSS Chair, Jenni Tranter 

 

 

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. No members can join or pay and attendance fee equal to the PHSS membership fee.

 

Exhibition and Sponsorship Opportunities

 

Click here to download flyer.

 

If you require accommodation please click here

 

 


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