High Potency API (HPAPI) Development & Manufacturing
Advance your highly potent API with specialized containment, development and manufacturing expertise.
Expert cGMP development and manufacturing of highly potent APIs, with advanced containment capabilities from grams to commercial scale.
Curia’s SafeBridge®-certified facilities include jacketed glass reactors, portable Hastelloy or glass-lined kettles, portable and fixed pressure filters/dryers, HPAPI isolators, as well as particle size reduction technology.
Capabilities
- State-of-the-art, SafeBridge-certified facility
- Equipment including cGMP-compliant glove box isolators and reactors capable of handling materials with OELs less than 0.1 ug/m3
- Manufacturing capabilities up to 1200 L reaction scale with batch sizes of 50–100 kilograms
- Large-scale cytotoxic capabilities
Key Technologies
- Hydrogenation
- Fermentation
- Biotransformation
- Flow chemistry
- Micronization
- Lyophilization
- Emulsions
- Suspensions
Capacity and Capability
Curia supports each stage of the highly potent product lifecycle. Whether you are embarking on your inaugural high potency program and need a consultative guide through the process or you simply need a strong partner to support your latest project. Our team has the flexibility, experience and expertise tailored to your need.
High Potency Experience
- Steroids (unique high potency capability)
- Hormones
- Complex small molecule development
- Antibody Drug Conjugates
High Potency Expertise from Discovery to Drug Product, Bolstered by Analytical Capabilities
Curia Network
High Potency Frequently Asked Questions
