API cGMP Manufacturing
Eurofins CDMO (Contract Development & Manufacturing Organization) is experienced with the development and validation of several molecule API processes that are in various stages of regulatory approval across the globe. Our facilities have successfully been inspected and approved by international regulatory agencies such as the USFDA (2008-2011-2014-2016) and Health Canada (2014-2016). The experienced quality team works with our clients to meet their phase appropriate quality and regulatory needs and is able to assist them with their regulatory filing; whether for preparation or review of CMC or DMF filings.
With more than fifteen years of development and manufacturing experience, Eurofins CDMO provides high quality and flexible facilities to take on complex chemical problems. To support our commercialization efforts, we operate multiple cGMP kilo laboratories to scale-up processes to the 50 litre scale for clinical and niche commercial API’s. In addition, we have sophisticated cGMP manufacturing units which can support process volumes upwards of 500L to provide larger quantities of API.
Our cGMP units are all equipped with cryogenic, hydrogenation, and chromatography capabilities. Speciﬁcally, we have invested Biotage™ systems chromatography units across the company from bench to multi-kilogram scale, allowing seamless transfer of complex puriﬁcation processes from benchtop to pilot scales to accommodate our clients’ needs through the drug development continuum. Eurofins CDMO also possesses high pressure preparatory LC capabilities for the laboratory and cGMP environments.
In addition to well-equipped facilities, we have a breadth of experience with a variety of chemical transformations including:
- Reductive amination
- Organometallics (RMgX, BuLi, LDA)
- Halogenations (POCl3, SOCl2, SO2Cl2)
- Reductions (LiALH4, NaBH4, DIBAL)
- Suzuki couplings
- Pauson-Khand cyclization
- Peptide chemistry
- Hydrogenation (catalytic, hydrogen transfer)
cGMP, ICH compliant stability studies are also doing to support regulatory CMC programs and process development:
- Conditions include: -80°C; -20°C; 5°C; 25°C/60%RH; 30°C/65%RH; 40°C/75%RH
- ICH Photostability Testing Capability
- Stability Studies: Raw materials, intermediates, API’s, and alternative salt and polymorph forms
- Stress studies, accelerated and long-term stability studies