The R&D laboratory specializes in the isolation techniques of natural products and their conversion to semi-synthetic derivatives. Mihulka’s staff has extensive experience with ergot and morphinan alkaloids isolated from natural sources. Starting materials are produced by extraction from plant or fungal materials and used for subsequent custom syntheses. We specialize in the discovery and development of novel value-added synthetic routes and in the process scale up to pilot plant and production scales.
Mihulka has the capabilities to manufacture clinical supplies and commercially marketed compounds in compliance with cGMP. The facility is equipped with glass, stainless steel, Hastelloy, or glass-lined reaction vessels with size range from 10 L to 250 L and corresponding accessories, including filters, dryers, and evaporators.
In-house testing includes the following QC services
Mihulka has the systems in place for cGMP compliant production. The QA department implements GMP enabling activities, including
Biotechnological services are provided by a partner company, Mycotech, LLC. Its main focus is on the development of new source of feedstock for ergot alkaloids synthesis using Mycotech’s proprietary cell cultures.