The journey from discovery laboratory to pharmacy shelf is long and arduous, particularly for highly potent API processing, which must be handled in compliance with complex regulatory requirements at each stage of the journey.
Pharmaceutical companies looking for a Contract Development and Manufacturing Organization (CDMO) to help them navigate should look for one with a combination of true expertise, capabilities and a robust assessment process giving all molecules a “potent passport” according to David O’Connell, Director of Pharmaceutical Development at PCI Pharma Services.
High potency active pharmaceutical ingredient (HPAPI) processing is an attractive market for CDMOs.
Regulatory demand for effective, lower-dose treatments combined with growing incidents of cancer, diabetes, and cardiovascular diseases has seen many pharmaceutical companies focus their R&D investments in HPAPI-based products. This focus, paired with the ever-present need to reduce costs, has increased demand for potent API processing services.
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As well as Potent API Processing we provide complete Drug Development and Manufacturing services
With over 35 years’ experience of processing potent and non-potent drug products, PCI provides a true partnership and consultative approach from pre-clinical formulation development and API characterization through to full commercial launch.