Challenges in Biological and Advanced Medicinal Therapeutic product manufacturing following GMP – PHSS Cleanroom Conference 2017

8th September 2017 | UCL School of Pharmacy London UK

PHSS Cleanroom Conference

This major PHSS cleanroom conference will address the key challenges in manufacturing Biological and Advanced Medicinal Therapeutic products (ATMPs) considering challenges in GMP compliance.

New biological products present new challenges in aseptic processing, contamination and cross contamination control at many different scales of processing. The conference considers the significant trend in change from traditional pharmaceutical ‘Block buster’ products, produced mainly by chemical synthesis, to developing biological products that employ more effective biological delivery mechanisms and interactions. Biological synthesis not only presents challenges in GMP, but process and patient risk profiles are very different to traditional pharmaceutical sterile product manufacturing, particularly considering new challenges in personalised medicinal therapies.

This conference presents the changing scene with significant advances in medicinal and therapeutic products together with a GMP inspector’s point of view on the challenges of GMP Compliance. In addition there are two presentations that cover facility design for biological product manufacture and Quality assurance in preparation of personalised Cell therapies.

Not a conference to miss to keep up with new biological product and medicinal therapeutic product development that now have the additional challenge of compliance to the revised EU GMP Annex 1.

PHSS Conference Visitors

Please support the Exhibition 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 the challenging area of risk based GMP, new biological product and Therapeutic products developments together with European regulatory perspectives and interaction with industry key opinion leaders and Subject Matter Experts.

About PHSS

The Pharmaceutical and Healthcare Sciences Society was formally constituted in September 1982 as The Parenteral Society, serving professionals whose experience and resources are directed towards the research, development, manufacture and control of Pharmaceutical and Healthcare products.

The Inaugural Meeting of the Society took place in Bath, UK, incorporating a Course on the Quality Assurance of Sterile Products which was oversubscribed.

PHSS draws its strength from the diversity of its membership and the openness of its organisation, encouraging the sharing and presentation of ideas for the common benefit of all.

The PHSS supports the world-wide harmonisation of GCP, GLP and GMP: a factor which is crucial in the ever-changing pharmaceutical and medical device industries.

Central to the objectives of the Society and its members are the safety and well-being of any patient in receipt of products manufactured by the technologies with which PHSS is concerned.

The Society is a founder member of the ESPC (European Sterile Products Confederation), and enjoys close links with A3P, France, R3Nordic, Scandinavia and AEFI, Spain.