CMC Pharma GmbH and AmpTec GmbH close consulting agreement for API-mRNA production according to GMP FDA 21 CFR Part 210, 211, ICH Q7 for IND/CTA use in early phase clinical studies

Hamburg, January 27th, 2017

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.

AmpTec GmbH is an ISO 13485:2007 certified provider of synthetic nucleic acids for worldwide leading companies in the field of molecular diagnostics and biotechnology and has already in 2012 implemented cGMP-compliant production of synthetic RNAs for diagnostic applications (GMP FDA 21 CFR Part 820).
In order to expand the scope for therapeutic applications (GMP FDA 21 CFR Part 210, 211, ICH Q7) AmpTec has established a cooperation with CMC Pharma to use their great consulting expertise in this field. CMC Pharma has completed training courses and an onsite GMP assessment.

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: “Today, November 23, 2016 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 more 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 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.”

New England Biolabs® Announces Agreement with AmpTec GmbH to supply key mRNA Synthesis Reagents

Ipswich, MA October 27th, 2016

New England Biolabs, Inc. (NEB®) has strengthened its position as a key supplier to the fast-growing RNA synthesis market by signing an agreement to supply critical reagents to AmpTec GmbH, a leading manufacturer of synthetic long RNAs and functional mRNAs for research, diagnostic and therapeutic applications. Under the terms of the agreement, NEB will manufacture and supply enzymes for in vitro transcription and capping of RNA.

Commenting on the relationship, AmpTec's President and CEO, Guido Krupp stated, "NEB has a long track record as leading supplier of molecular biology enzymes and associated reagents for life science research. With this agreement, the strengths of NEB and AmpTec are combined to provide the market with the highest quality RNA for projects of all scales, from micrograms to grams."
“We are pleased to formalize our relationship with AmpTec. By applying our technical and production expertise in enzyme chemistry, we can support AmpTec as a leading service provider in the RNA synthesis market," said Julie Moore, Director of Global Customized Solutions at NEB. "NEB has built an RNA synthesis product portfolio to address the market's growing needs. By working with innovative companies, such as AmpTec, we can now ensure that these technologies achieve their potential.”
To learn more about NEB's product offerings in the mRNA synthesis space, download the RNA Synthesis brochure at www.neb.com/litrequest. To inquire about NEB's custom capabilities for supplying RNA synthesis reagents, contact us at NEBsolutions@neb.com.

About New England Biolabs
Established in the mid 1970’s, New England Biolabs, Inc. (NEB) is the industry leader in the discovery and production of enzymes for molecular biology applications and now offers the largest selection of recombinant and native enzymes for genomic research. NEB continues to expand its product offerings into areas related to PCR, gene expression, sample preparation for next generation sequencing, synthetic biology, glycobiology, genome editing epigenetics and RNA analysis. Additionally, NEB is focused on strengthening alliances that enable new technologies to reach key market sectors, including molecular diagnostics development. New England Biolabs is a privately held company, headquartered in Ipswich, MA, and has extensive worldwide distribution through a network of exclusive distributors, agents and seven subsidiaries located in Canada, China, France, Germany, Japan, Singapore and the UK. For more information about New England Biolabs visit www.neb.com.

About AmpTec GmbH
AmpTec manufactures high quality synthetic nucleic acid products for research, diagnostic and therapeutic markets. AmpTec is ISO 13485 certified and its production facility (at present about 4,000 square feet) is compliant with FDA21 CFR part 820 (cGMP manufacturing). AmpTec's solutions help advance biomedical research with special focus on commercial applications the fields of IVD and mRNA therapeutics. Founded in 2005, AmpTec is a privately held firm based in Hamburg, Germany and employs currently 15 scientists and other professionals. For more information about the firm and products, visit their web site at www.amp-tec.com.

Eurofins Genomics and AmpTec close distribution agreement for very long synthetic RNAs

Ebersberg, Germany, July 1st, 2014

Joint expertise to provide custom services for in vitro transcribed (IVT) single- stranded (ss) and double-stranded (ds) RNAs and for functional synthetic mRNAs.

Eurofins Genomics, international market leader in genomic services, and AmpTec, internationally recognized provider of RNA technology products, have agreed on non-exclusively co-marketing AmpTec's IVT-RNAs globally.

The co-marketing agreement for IVT ssRNAs, dsRNAs and mRNAs includes RNAs up to several thousand bases and a wide range of modifications. All nucleic acid products are offered at research grade in compliance with regulations of ISO13485 and at Good Manufacturing Practice (GMP) grade on request, in order to assure highest product quality and regulatory compliance.
The partnership will deliver premium synthetic ssRNAs, dsRNAs and mRNAs that are widely used in a variety of applications from in vitro diagnostics of pathogens and detection of rare gene mutants to the rapidly growing field of companion diagnostics. Together, the two companies will serve an international market with their combined custom services for synthetic genes and for very long synthetic RNAs.

“The cooperation will allow us to broaden Eurofins’ portfolio with innovative nucleic acid products. By sharing best practices, clients will benefit from an unparalleled spectrum of custom services for IVT-RNAs, which in turn should fuel further market share growth for both partners.”, says Bruno Poddevin, Senior Vice-President Eurofins Genomics.
“Eurofins’ broad expertise in nucleic acid chemistry is a perfect fit for our RNA technology portfolio”, says Guido Krupp, President of AmpTec. “Eurofins’ emphasis on direct and flexible interaction is very important for us” confirms Peter Scheinert, CSO of AmpTec. “With this agreement, our long-term partnership will reach new levels of market awareness and international recognition.”

For complete details about Eurofins Genomics’ very long RNA synthesis service, visit our web page at www.eurofinsgenomics.eu/long-rna.