18. Mai 2020 Facing the Challenge >> AmpTec

LSN: What are the core competencies of AmpTec?

Peter Scheinert: AmpTec GmbH is an internationally active contract manufacturing company (CMO) with comprehensive services for cGMP manufacturing of synthetic nucleic acids for biotech and pharma companies. Our company was founded in May 2005 and is a highly reliable partner for the biotechnology & pharmaceutical industry with a proven track record of 15 years right now.  We provide customized solutions individually produced for each client and offers guaranteed product quality produced according to international cGMP guidelines and in a highly regulated state-of-the art GMP environment.

AmpTec offers two product lines:

1. Synthetic nucleic acids for diagnostic applications: Key products for molecular biological pathogen diagnostics are customer-specific long RNAs (in vitro transcripts) and DNAs (PCR products), which are produced as reference material based on a sequence provided by the customer in a length of up to 13,000 bases.
2. Synthetic nucleic acids for therapeutic applications: Key products are fully functional mRNAs for manufacturing of drug substances or active pharmaceutical ingredients (APIs) for the pharmaceutical industry using mRNAs to develop a new category of medicines. AmpTec mRNA products are already used by our clients for clinical trials (ex vivo), pre-clinical trials (in vivo) and clinical trials phase I (in patient).

LSN: How do you use these competencies to facing the challenge of the corona virus pandemic?

Peter Scheinert: As part of a highly standardized manufacturing process, e.g. reference materials can be produced by AmpTec within a very short time for the laboratories and shipped worldwide.  As a result, it is possible to react very quickly to the emergence of new pathogens or pathogen variants.

LSN: What is your concrete offer?

Peter Scheinert: AmpTec offers synthetic IVT-RNAs as reference material to support worldwide reliable COVID-19 diagnostics. In order to support the validation of the COVID-19 assays in laboratories worldwide, We work in close cooperation with the laboratories to produce SARS CoV-2 standards in the form of RNA in vitro transcripts. This enables laboratories to validate the entire process of a molecular assay for the amplification and detection of SARS-CoV-2.

Furthermore we now offer fast track option for manufacturing of synthetic, fully functional SARS-CoV-2 Protein mRNAs for vaccination approaches in cell culture, animal models, preclinical- and Phase I clinical trials.

Manufacturing process of fully functional SARS-CoV-2 mRNAs starts from scratch. Only protein- or nucleic acid sequence information is needed. This service is intended to enable a broad group of institutes and researchers worldwide to work with SARS-CoV-2 mRNAs on mRNA-based approaches e.g. vaccine development. Batches of mRNAs can be produced from any sequence without lenghts limitation.

LSN: AmpTec manufactures EURM-19, a universal COVID-19 positive control IVT RNA to facilitate the quality control of the detection of SARS-CoV-2 in the testing laboratories. How does this test work?

Peter Scheinert: In response to the SARS-Cov-2 pandemic in March 2020, the European Commission announced the availability of a universal IVT-RNA as a COVID-19 positive control called EURM-019 for the quality control of the detection of SARS-CoV-2 in the test laboratories.

EURM-019 was manufactured by AmpTec in accordance with ISO 13485, including the requirements of the FDA CFR Part 820 (cGMP production). This RNA solution is intended to be used as a positive quality control sample in the testing for the presence of the coronavirus SARS-CoV-2, also referred to as 2019-nCoV or virus causing the disease COVID-19.

It can be used to verify the correctness of the reverse transcription and amplification steps for the SARS-CoV-2 real-time RT-PCR assays and it enables laboratories worldwide to validate the entire process of a molecular assay for the amplification and detection of SARS-CoV-2. EURM-019 is fully compatible with the official WHO recommended methods used in the EU, Asia and the United States to determine the presence of SARS-CoV-2. The material can also be used to evaluate and validate the numerous test kits based on the RT-PCR currently being developed worldwide. The results of diagnostic and screening tests can only be ensured by providing high-quality reference materials for laboratories and manufacturers.