Résultats de la recherche - 2 results

OMCL testing and the API working group: Part of the solution?

a fingerprint study (MSSFP). An MSS, according to Ph. Eur. only gives an indication of the quality of the product on some distinct parameters, often chosen based on the manufacturing process. A MSSFP study allows ...

Falsification of biotechnology drugs: current dangers and/or future disasters?

contaminations and product or process related impurities. Moreover, also unauthorized polypeptides or polypeptides which failed clinical trials or are still subject of clinical or pre-clinical assessments have ...

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