CTM Manufacturing
Regulatory authorities require clinical trial dosage forms of an NCE be manufactured under cGMP conditions (FDA Guidance for Industry "cGMP for Phase 1 Investigational Drugs" and FDA Guidance for Industry "INDs for Phase 2 and Phase 3 Studies") and ICH Guideline (Q7 "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients", Q8(R2) "Pharmaceutical Development", and Q9 "Quality Risk Management"). Azopharma's cGMP facilities, experienced team and unique approach to CTM manufacturing give our sponsors an opportunity to accelerate development of their lead compounds through our proprietary Phase I Express® process. We can prepare the required materials for clinical trials to support up to Phase II studies and can assist clients in determining their drug supply needs.
Azopharma also provides packaging in bottles, tubes, vials and blister packs that can be labeled for open or blind clinical studies. Some products can be blinded for clinical studies using over-encapsulation and banded to prevent tampering. Matching placebos can be formulated and manufactured for comparator studies.
We operate manufacturing facilities and provide additional services to accelerate development and scale-up for your API, whether an existing drug or NCE. Azopharma specializes in highly potent compounds and cytotoxic drugs processed in our high containment suites with appropriate protection for the environment and our personnel.
Our CTM manufacturing capabilities include:
- Complete processing of most dosage forms
- Monitored storage facilities for both raw material and finished bulk product
- Suites for processing of solvent-based products
- Dedicated facilities for cytotoxic and highly potent drugs
- Testing and releasing of raw materials
- Packaging and labeling of product
- Product specific validation
- Stability storage and testing for finished product dosage forms
- Regulatory support
- Support transfer to CMO for large-scale supplies
Azopharma additionally offers full manufacturing services for:
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