The Germany-based businesses are cooperating to expand their GMP (good manufacturing practice) fine chemical capabilities. For enzyme-specialist Enzymicals, which was founded in 2009, the deal allows it to scale up operations.
“It gives us access to a GMP production site”, Rainer Wardenga, chief scientific officer at Enzymicals, told in-PharmaTechnologist. Enzymicals will transfer existing clients to Herbrand PharmaChemicals’ Gengenbach, Germany plant, Wardenga said, and expects the move will help it add new customers.
Having entered into the relationship Enzymicals is now working to prepare its biocatalytic processes for use on a larger scale. “Our focus is on establishing the processes at a medium lab scale ahead of scale-up”, Wardenga said.
The time taken to scale-up processes will dictate when production begins, Wardenga said. When scale-up is complete the processes will be used to produce APIs (active pharmaceutical ingredients) and intermediates in quantities up to several tons per year.
“The opportunities at Herbrand PharmaChemicals will enable us to perform large scale production processes in Germany under GMP conditions and thus to meet the requirements of our customers with respect to quality and timely delivery”, Ulf Menyes, of CEO Enzymicals, said in a press statement.
Working with Enzymicals will allow Herbrand PharmaChemicals to expand its product portfolio. In particular Herbrand PharmaChemicals hopes to obtain enantiomerically pure building blocks and is evaluating this and other possibilities to enter new markets.
“Herbrand PharmaChemicals now expands its product portfolio taking advantage of the opportunities within 'white biotechnology' and thus takes a new position at the market”, Bernd Köhlmann, head of technics and production at Herbrand PharmaChemicals, said in a press statement.