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PHSS & UCL Q3P Annual Conference 2018
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PHSS & UCL Q3P Annual Conference 2018

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

 Export to Your Calendar 11/09/2018
When: Tuesday, September 11, 2017
9:00 AM
Where: Map this event »
School of Pharmacy, UCL
Brunswick Square
London WC1N 2CR
United Kingdom
Contact: Tamsin Marshall
01793824254


Online registration is available until: 31/08/2018
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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 biological products 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 viral vector to consider the pathway and GMP challenges from development to commercial scale up.

 

Aseptic-Containment is developing and will be discussed where containment is required for new products types because they present risks to operators down to new OEB6 levels or have cross contamination challenges in a facility or between products manufactured in the same facility.

 

The revised Annex 1 details a requirement for a Contamination control strategy and this conference will explore how such a strategy should be developed for biological product/ ATMP processing where residual chemical compatibility of bio-decontamination and disinfection agents used in contamination control often challenge biological product efficacy.

 

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 medicines are starting to be characterised and further challenge regulations. A new development will be presented with an overview of challenges that have been faced towards regulatory compliance and alignment. 

 

An Exhibition is included with exhibitors who can provide further knowledge and support with technologies and essential supplies/ services in sterile product manufacturing.

International attendees are encouraged to engage with this challenging area of risk based GMP and QRM applied to new biological and Therapeutic products.

 

Exhibition and Sponsorship Opportunities

 

Click here to download flyer.


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