New biological and Advanced Therapy Medicinal Products (ATMP) therapies require an alternative GMP framework. Cherwell Laboratories, supplier of environmental monitoring and process validation products, has confirmed its continued support for the Pharmaceutical & Healthcare Sciences Society (PHSS) - UCL Q3P Annual Conference 2018.
This year’s event, taking place in the Wilkins Building at University College London (UCL), will address the key challenges in manufacturing and aseptic processing in the new area of Biological and ATMPs, considering issues in GMP compliance and application of quality risk management.
ATMPs are medicinal products using gene therapy, cell therapy and tissue engineering, which offer new opportunities to transform the treatment of human diseases and dysfunctions. However, as biological medicinal products with very specific and varied characteristics, they present new challenges in aseptic processing and contamination control at many different scales of processing.
To address this, the EU has recently introduced new GMP guidelines specifically for ATMPs, though for many it is unclear how the new GMP for ATMPs and recent revised Annex 1 sterile medicinal product manufacturing requirements will work together.
Agenda highlights include: GMP for ATMPs and connection to EU GMP Annex 1 from a GMP inspector’s point of view; a case study of the development and aseptic manufacture of a viral vector used in an ATMP cancer therapy; a case study presenting the key challenges of a biological product coming through development, formulation and scale-up progression into aseptic manufacturing, containment and GMP; and a Q&A session on Annex 1.
Andrew Barrow, Sales Manager at Cherwell, said: “This key annual conference always succeeds in bringing together experts in regulatory compliance, drug safety and production efficiency. ATMPs present special challenges to microbiology and patient safety, and this conference will certainly generate some new questions for us and we look forward to discussing how Cherwell can support ATMP manufacturers.”
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