With over 25 years of experience in the handling of highly potent intermediates and APIs, CordenPharma utilises sophisticated technologies and the combined capabilities of multiple global cGMP facilities to produce highly potent pharmaceutical products and their active ingredients.
CordenPharma is additionally experienced in the small-volume production of highly potent peptide APIs for commercial use with containment safety systems and procedures suitable for the production of compounds with exposure limits as low as 1ng/m3.
API – Highly Potent Manufacturing to 1 ng Exposure Limit
Manufacturing vessels with high flexibility in size (1-16,000L), compatibility (Hastelloy, glass-lined, steel) and temperature (-110°C to +120 °C)
Multiple filtration options (centrifuges, filter dryers, filter presses) and material compatibility (Hastelloy, stainless steel)
Multiple drying options (agitated and static dryers) and powder handling (isolator technology)
Preparative HPLC Capability in Highly Potent Facilities
Flexible capacity in manufacturing compounds up to Occupational Exposure Limits (OEL) of 1 ng/m³ (full cGMP pilot plant for process scale-up and development, LTSS batches, start-up batches, and full-scale cGMP manufacturing)