|
|
|
Highly-Potent APIs and Cytotoxics
Highly Potent APIs (HPAPIs) and Cytotoxics
Highly-Potent Active Pharmaceutical Ingredient (HPAPIs or HPAIs) molecules are proven to be effective at much smaller dosage levels than traditional APIs, but their potent characteristics present specific handling challenges. As a leader in the fast-growing HPAPIs manufacturing area, including bio-conjugation and fermentation, SAFC Pharma® offers:
| |
15 years experience in HPAPI development and manufacturing to Category IV |
| |
Purpose-built Safebridge® certified facilities with specialized
containment engineering |
| |
A wide range of manufacturing capabilities |
| |
Highly-trained personnel |
| |
Extensive regulatory experience with active DMFs filed in over 30 countries |
| |
Single point of contact project management |
|
 |
| Capabilites |
| |
HPAPIs: Manufactured in state-of-the-art facilities that includes a hazard assessment lab, process development labs, kilo labs and pilot plants to handle high-potent and cytotoxic molecule manufacturing to commercial scale batch sizes.
-- Additional manufacturing capabilities |
| |
|
| |
Highly-potent bio-conjugates: Combines customer antibodies with potent APIs and linkers from SAFC. New purpose-built high-potent conjugation suite provides pre-clinical to clinical trials scale capabilities with room for expansion as the products move toward commercialization.
-- Additional high-potent bio-conjugation services |
| |
|
| |
High-potent fermentation: cGMP production capabilities focus on secondary metabolites, cytotoxins and highly-potent large molecule proteins.
-- Additional high-potent fermentation services |
| Quality Management |
| |
Dedicated Quality Assurance (QA) units |
| |
Highly-experienced personnel |
| |
Operations to industry standards |
| |
Proven and experienced quality assurance oversight for HPAPIs |
| |
Clinical trials APIs manufactured to ICH Q7A guidelines |
| |
Rigorous compliance program in place |
|
|
