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Birte Scharf
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Birte Scharf

Senior Scientist GMP Compliance, Franz Ziel GmbH, Billerbeck.

Published articles

Highly Innovative Medicines: Advanced Therapy Medicinal Products (ATMPs) – Part 1

Highly Innovative Medicines: Advanced Therapy Medicinal Products (ATMPs) – Part 1

Advanced therapy medicinal products (ATMPs) are an innovative class of medicinal products characterised by the use of advanced technologies.They target the underlying genetic, cellular, or tissue-based abnormalities of diseases and thus offer the potential for cure or at least a long-term therapeutic benefit.

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Highly Innovative Medicines: Advanced Therapy Medicinal Products (ATMPs) – Part 2

Highly Innovative Medicines: Advanced Therapy Medicinal Products (ATMPs) – Part 2

To address the specific requirements for manufacturing ATMPs, separate GMP regulations were published as Part IV of the EU GMP Guidelines in late 2017.

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Smart Strategies for Handling Indirect Product Contact Components

Smart Strategies for Handling Indirect Product Contact Components

Aseptic filling processes: Handling indirect product contact parts in compliance with the revised Annex 1 of the EU GMP Guide.
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