Monday, March 05, 2018 9:36:06 AM
Thank you for the Job posting:
“The GMP Production Scientist will be responsible for performing batch manufacturing of the company’s contract manufacturing products to support the delivery, in the first instance, of Advanced Therapeutic Medicinal Products (ATMPs) as both ”Specials” and as Investigational Medicinal Products (IMPs)"
https://www.indeed.co.uk/viewjob?jk=cc093a397983ab93&tk=1c7o2r9b7386s93t&from=companyalert&alid=59e10165e4b072486e9ee674&utm_source=jobseeker_emails&utm_medium=email&utm_campaign=job_alerts&rgtk=1c7o2r9b7386s93t
An advanced therapy medicinal product (ATMP) is a medicinal product which is either:
• a gene therapy medicinal product
• a somatic cell therapy medicinal product
• a tissue engineered product
see: Guidance Advanced therapy medicinal products: regulation and licensing
https://www.gov.uk/guidance/advanced-therapy-medicinal-products-regulation-and-licensing
This is from www.clinicaltrialsregister.eu:
DCVAX-L:
D.3.11.3.1 Somatic cell therapy medicinal product Yes
https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/GB
I think maybe this is the scientific
recommendation:http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/08/WC500147207.pdf
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