AmpTec looking to achieve full GMP compliance for APIs
AmpTec GmbH is an ISO 13485:2009 certified provider of synthetic nucleic acids. The company offers stocked mRNA catalog products from microgram to gram scale range and multi-decagram scale range for customized fully functional mRNAs with any sequence.
Dr. Peter Scheinert, CEO of AmpTec GmbH told us the company has been contacted by “a number of US customers” over the past year that have asked about API-mRNA production for IND/CTA use in clinical studies.
As such, the company contacted CMC Pharma GmbH for consultation as it looks to expand its offerings into clinical applications.
CMC Pharma GmbH – a GMP service provider – has already completed training courses and an onsite GMP assessment.
Stefan Schmitz, CEO of CMC Pharma commented in the press release, “It can be stated that AmpTec is compliant with the requirements of 21 CFR 210 and ICH Q7 (section 19: APIs for use in clinical trials) which is adequate at this phase of the project for early clinical studies.”
Schmitz explained AmpTec is expected to be compliance with 21 CFR 211 and ICH Q7 (GMP for API manufacturers) “at a later stage.”
“We want to be prepared for a potential FDA audit,” said Scheinert.
CMC Pharma will implement follow up reviews to monitor the AmpTec’s progress towards full GMP compliance.
“Now, we have to see what the next step with [our] customers will be,” Scheinert added.
