Mark Townend

Background

About Mark Townend

Highly experienced professional, specialising in biologics and vaccine manufacture and QP release- 29 years experience in steriles and biologics, of which 21 years as a releasing QP- Work with large multinational blue chip companies to small, niche, start-up companies - IMP QP release of various biologics into Phase I, II, clinical trials- Commercial QP release of vaccines and recombinant proteins on a global scale- COVID-19 vaccine Drug Substance manufacture and QP release - Seasonal flu vaccine manufacture and release in fourteen northern hemisphere campaigns, releasing millions of doses to market under significant time pressure- Master and working cell bank release, various cell types- Cell culture manufacture of IMP and commercial products, with a variety of mammalian and bacterial cells e.g. HEK293, MDCK, E. coli, C. botulinum- Viral vector IMP manufacture and release of Adenovirus, MVA, ChAdOx1 - Recombinant protein manufacture and release, IMP and commercial, in complex supply chains requiring multiple intracontinental journeys- Radiopharmaceutical manufacturing oversight and release in the form of ARC (antibody-radionuclide-conjugate)- Full spectrum of aseptic manufacturing scale from one vial per lot filled by hand, to hundreds of thousands of syringes per lot filled using high speed isolator lines- Global cold chain shipments from -80degC to +5degC - Tech transfer QA rep for aseptic filling projects to US, Australia and Switzerland - Quality lead in investigating worldwide high profile manufacturing and release issues such as sterility test failures, media simulation failures, product quality release OOSs, potency OOSs on stability etc - FDA PAI preparation and remediation projects- Hosting and fronting in FDA and MHRA audits- Person in plant at CMOs on behalf of Clients, helping manage the CMOs. Conversely also worked for CMOs, helping manage their Clients.