We have the expertise, capabilities and facilities to take on your custom high potency API development and manufacturing challenges.
We have been reliably developing and manufacturing custom high potency APIs and compounds for more than 15 years, including:
- Cytostatics/protein kinase inhibitors
- Ultra-potent cytotoxic drug substance
- Drug linkers
- PEG and cyclodextrin polymeric conjugations
- Drug product intermediates
- Antibody Drug Conjugates (ADC) payloads
Custom high potency API development
With a strong focus on safety, you can count on us to provide expertise in cytotoxic and cytostatic APIs, including:
- Process development
- Analytical and QC testing
- Laboratory scale cGMP manufacturing up to 20L
- Controlled access high potency center for development
- Best-in-class barrier isolation
- Highly regimented safety protocols
During the development of custom high potency APIs, we use a risk assessment approach to screen and assign occupational exposure limits (OELs) to APIs and intermediates with unknown toxicological properties.
This advanced methodology allows our expert team to make data-driven risk management decisions, decreasing time using excessive containment controls and lowering manufacturing costs.
We also employ the traditional exposure control band (ECB) methodology, which defines general health concerns, administrative and regulatory requirements, monitoring strategies and facility design requirements.
Custom high potency API manufacturing
Our custom high potency API manufacturing capabilities include:
- Commercial manufacturing up to 16,000L
- Up to ECB 4 (< 1 µg/m3)
- cGMP kilo laboratory up to 150L
- cGMP pilot plant
- 200L and 1,200L glass reactors
- 1,200L stainless steel reactor
- Two 400L Hastelloy reactors
- Multi-purpose solids handling suite
- cGMP micronization facility