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In the pharmaceutical environment, the qualitative and regulatory requirements for raw materials, independently if excipients or active substances, are very high.
For several year`s we are already working with a medium-sized partner laboratory in Germany on enzymatic contract research / contract manufacturing. Our focus in this area is not, being able to produce existing products more cheaply, but to be able to produce products that are not available at all.
The compound in which our client was interested in is being produced and used in large quantities. However, this product can`t be used in the strictly controlled pharmaceutical sector because the quality requirements are not met – Exact definition of the raw materials are required, BSE / TSE certificates, contamination profiles, a very high assay and a specified, enormously low water content.
With these challenging conditions, a very hygroscopic product and a particularly competent manufacturing partner, we took on the exciting task of our customer.
The aim was to produce the intermediate in a defined purity with a water content of <0.5% and a comprehensive documentation. After several preparatory work, procurement of a suitable chromatography column, the search for suitable raw materials, the purchase of a large nitrogen tent to protect the freeze-dryer we finally could start with the project. With many highs and lows, at some points where we no longer believed in the realization of the project, we were finally able to deliver the goods including documentation to our customers after 12 months and this could restart its dormant production due to lack of raw materials
Biochemical and Microbiological Contract Work
Together with partners, we produce sample batches and small-scale of fine chemicals on the basis of biocatalytic development work for you in the double-digit kg scale. Likewise, processes for the production of raw materials and precursors for the production of pharmaceutical products are developed and substances are produced on customer’s request in the desired scale. For these productions, biomass, enzymes and crude extracts from microbial and plant sources are screened, isolated and prepared for use in biotransformation. We offer services for customer-related problems with a focus on biocatalytic process development. Screenings can be performed from the microtiter plate to mini-bioreactors up to shake flasks, stirred reactor and small fermenters. Subsequent process developments and a scale-up to your desired scale, can be transferred to production. Examples of products include the so-called chiral alcohols ((R, R) -2,5-hexanediol, (S, S) -2,4-pentanediol, (S) – (-) – 1-phenylethanol).