§ 13(1) sentence 1 no. 3 AMG
Anyone manufacturing active substances of human, animal or microbial origin, or produced by genetic engineering, on a commercial or professional basis needs an authorisation from the competent authority.
Case studies · Clinical trial sponsor, innovative biotech company in cancer therapeutics
Recombinant protein from old stock made usable
A recombinant protein manufactured some time ago was to be used in an investigational medicinal product. We confirmed its GMP compliance and so created the conditions for further processing.
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services from one provider
At a glance
Can a long-stored active substance still be used to make an investigational product?
- Client
- Clinical trial sponsor, innovative biotech company in cancer therapeutics
- Task
- An active substance manufactured some time ago was to be used to manufacture an investigational medicinal product.
- Outcome
- The GMP compliance of the recombinant protein has been confirmed.
- What A&O took on
- QP Batch Release GMP and GxP Consulting & QA Support
How it went
Starting point, approach, outcome.
Told plainly, in the order it actually happened.
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01
Starting point
What the client came to us with. An active substance manufactured some time ago was to be used to manufacture an investigational medicinal product. The active substance is a recombinant protein and therefore requires an authorisation under § 13(1) no. 3 AMG. Its GMP compliance had to be assessed before use. The sponsor needed a partner to help establish its GMP compliance and to release the active substance for manufacture of the investigational medicinal product. The GMP-compliant manufacture of the investigational medicinal product was also to be overseen and the product released for use.
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02
Approach
What we actually did. We assessed whether the recombinant protein (active substance) had been manufactured in compliance with GMP. We oversaw the GMP-compliant storage and analytical testing of the active substance and conducted audits for this purpose.
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03
Outcome
The outcome. The GMP compliance of the recombinant protein has been confirmed. This means the active substance can now be processed further and used in a clinical trial.
Terms used in this case
Anonymised. Confidentiality is part of our business; we only name clients with their consent.
The legal framework
What the rules required in this case.
EU GMP Guide, Part II
Part II sets out GMP for active substances, with a dedicated section on cell culture and fermentation; retest and expiry dates must be based on stability data.
Regulation (EU) No 536/2014, Art. 63
Investigational medicinal products must be manufactured in line with good manufacturing practice to protect trial participants and ensure the reliability of trial data.
Regulation (EU) No 536/2014, Art. 62
The Qualified Person ensures that each batch of the investigational medicinal product meets the requirements of Article 63 and certifies this.
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