Custom Synthesis & Biotechnology.
Midas Pharma is your partner for custom synthesis and biotechnology under strict confidentiality.
Our objective: to offer our customers comprehensive solutions like synthesis development for your NCEs, impurity-synthesis, cGMP-production, compilation of the CMC-documentation and GMP-audits of our manufacturing partners.
The key elements in our offer are as follows:
- Multi-step syntheses with our international manufacturing partners on an exclusive basis.
- Production of pharmaceutical intermediates and active ingredients in accordance with ICH Q7a.
- Development of processes and up-scaling of NCEs for clinical development.
- Upscaling and production of commercial volumes.
- Contract manufacturing in accordance with our client’s processes and specifications.
- Biotechnological production of recombinant proteins and monoclonal antibodies. We are able to perform the upstream-processing with bacteria, yeast and mammalian cells.
- Classical fermentation of antibiotics (including your new development candidates).
We offer a wide range of chemical reactions, including key technologies such as phosgenation, cryogenic reactions, continuous nitration, chiral synthesis, azide chemistry, high-pressure hydrogenation with sophisticated catalysts, peptide-chemistry, containment production of cytotoxic compounds and aseptic production of sterile active ingredients.
We support your regulatory work by developing documentation like CMC sections and ASMFs (DMFs) for the new product.
You can count on that.
Our work is transparent and we offer our clients direct access to our manufacturing partners. We guarantee strict confidentiality for all client projects that we pursue in collaboration with our partners.
