Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Examples of processes not considered “substantial manipulation” (1394/2007/EC Annex I)

 Cutting  Grinding  Shaping  Centrifugation  Soaking in antibiotic or antimicrobial solutions

 Cell separation  Cell concentration  Purification  Filtering  Lyophilisation  Freezing  Cryopreservation  Vitrification

 Sterilisation  Irradiation

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TOPRA MSc Module 18: Drug Device Combinations and other Technology

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What are ATMPs?

Advanced Therapies – US ● Somatic cell therapy guidance 1998 covered key areas of – Prevention of transmission of communicable diseases – Collection of donor cells – Cell banking – Release testing/product characterisation ● Recently defined “Regenerative Medicine Advanced Therapy” in the 21 st Century Cures Act – a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products – Also includes gene therapies – RMAT designation expedited program – Under jurisdiction of CBER Office of Therapeutic Products (OTP) (formerly Office of Tissues and Advanced Therapies)

TOPRA MSc Module 18: Drug Device Combinations and other Technology

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