Moravek offers the GMP-compliant production of custom 14C-labeled active pharmaceutical ingredients (APIs). Our talented synthetic and purification chemists are proficient in a wide variety of techniques and can produce nearly any custom 14C-labeled compound for use in clinical trials.
GMP Batch Production
Our GMP production processes include:
- Production in one of four highly engineered ISO Class 7 cleanrooms
- Verification of production area cleanliness by TOC
- Documentation of production work in a serialized batch record
- SOPs for all key activities
- Use of all new glassware
- Quarantine and release of received materials, reagents, and solvents by Moravek Quality Assurance
- GMP HPLC purification including all new media and tubing
- Conversion of the product to the desired final form (crystallization, salt formation/removal, dilution with non-labeled GMP API, dissolution, lyophilization, etc.)
Our GMP production services are conducted by experienced and trained laboratory staff. Since 2012, we have successfully manufactured over one hundred GMP 14C-labeled APIs.
Non-GMP Technical Batch Production
Prior to the full-scale GMP production of a 14C-labeled API, a non-GMP radiolabeled technical batch is routinely prepared in order to test the planned production steps. Then, using information from the technical batch production, Moravek finalizes the detailed master batch record to be used during the GMP production.
There are a variety of benefits to having a 14C-labeled technical batch prepared prior to the GMP production, including:
- Ensuring that the planned production process can be successfully carried out to completion
- Showing that we can meet the proposed GMP specifications
- Resolving any issues that may arise during radiosynthesis, purification, or analysis prior to the full-scale GMP manufacture
- Drafting and revising the master batch record
- Conducting stability studies on the technical batch product to determine stability and the proper storage conditions of the 14C-labeled API prior to the GMP batch manufacture