AmpTec and CMC Pharma Close Consulting Agreement about API-mRNA Production for IND/CTA Use in Early

AmpTec GmbH is an ISO 13485:2009 certified Provider of High Quality synthetic nucleic acids for worldwide leading companies in the fields of molecular diagnostics, biotechnology and therapeutic applications. AmpTec GmbH benefits from nearly 20 years experience in the production of Very Long Synthetic RNAs and has proudly teamed up with the leading manufacturers Eurofins Genomics, New England Biolabs and Jena Bioscience in order to provide fully functional mRNA Synthesis Solutions for All Scales. In 2016 AmpTec expanded its facilities in Hamburg from 2,000 square feet to more than 6,000 square feet.

AmpTec offers stocked mRNA catalogue products from microgram to gram scale range and multi-decagram scale range for customized fully functional mRNAs with any sequence (presently up to 12 kilobases). Manufactured in a regulated environment, the mRNAs from AmpTec can be provided in any packaging format with extensive Quality Controls, including customised solutions.

In 2012 AmpTec has already implemented cGMP-compliant production of synthetic RNAs for diagnostic applications (GMP FDA 21 CFR Part 820). In order to expand the scope for therapeutic mRNA applications according to GMP FDA 21 CFR Part 210, 211, ICH Q7 AmpTec has established a cooperation with CMC Pharma GmbH to use their great consulting expertise in this field. CMC Pharma has already completed training courses and an onsite GMP assessment.
AmpTec offers a strong partnership in the regulated environment of early phase clinical trials.

CMC Pharma GmbH is a GMP service provider for pharmaceutical and life science companies as well as their suppliers. CMC Pharma offers FDA registration services (US agent with permanent address in the USA) for companies producing pharmaceutical drugs or preparations (small molecules, biotech, APIs), medical devices, foodstuffs or food additives. In addition to core competencies, CMC pharma offers also services such as translation of specialist texts, interpreting services, e.g. for FDA inspections. CMC Pharma ´s  US Agent maintains close contacts to  FDA officials. The team offers "Mock audits" by  former FDA investigators, as well as support in the preparation, execution and follow-up. CMC offers these services for all above mentioned areas from pharma to food.

Peter Scheinert, CEO of AmpTec, says: "We are very pleased about the productive cooperation with CMC Pharma and their impressive training experience."

Stefan Schmitz, CEO of CMC Pharma, says: "The announced first review of AmpTec´s compliance review with cGMP (21 CFR 210, 211) was performed. 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.
At a later stage, with the beginning of clinical phase 3, it is expected by the authorities to be also in compliance with 21 CFR 211 and fully in compliance with ICH Q7 (GMP for API manufacturers). Before full GMP compliance for API manufacturers is achieved by AmpTec, a few things need to be reviewed and adjusted. Follow-up reviews will be implemented to monitor the step-by-step progress towards full GMP compliance.
The commitment of AmpTec´s management and staff to drive the company in the direction of full GMP compliance for API manufacturers is highly appreciated and will lead to a successful transition from preclinical to clinical and market supplies."