10 October 2018 - - German biotechnology company c-LEcta has inked a European sales and distribution agreement for its Denarase with VWR, part of US-based specialty chemical company Avantor, the company said.

The highly active nuclease enzyme offers more efficient solutions for the removal of genetic information carriers (nucleic acids; DNA and RNA) in biopharmaceutical processes to pharmaceutical manufacturers.

The availability and distribution of Denarase via VWR's well established European channels harbors the potential for c-LEcta's product to gain additional share in a highly dynamic market.

Denarase helps to remove nucleic acids from many applications of red biotechnology and molecular biology to be marketable and to comply with regulatory requirements under lucrative and more biocompatible conditions.

It has proven to be robust under demanding process conditions and quantitatively removes interfering host cell DNA and RNA from fermentation batches, e.g. during the production of vaccines and biopharmaceuticals.

The complete removal of nucleic acids from pharmaceutical products is a strict regulatory demand. Furthermore, the handling of process liquids (e.g. in filtration or chromatography) can be considerably simplified and the follow-up costs reduced to a competitive level.

Therefore, Denarase is the ideal choice for pharmaceutical manufacturers to optimize process efficiencies and improve product recovery rates for the production of safe and compliant pharmaceutical products.

Denarase is manufactured using a patent protected production process based on the recombinant expression in an endotoxin-free Bacillus production host.

The manufacturing process does avoid the use of raw material of animal origin and antibiotics and is run in full compliance with cGMP (current Good Manufacturing Practice) requirements.

Based on this agreement, Denarase will now be available through vwr.com and all other regular VWR sales channels in Europe.