Moravek offers analytical method transfer services for your 14C-labeled active pharmaceutical ingredient (API) manufacturing campaign. We offer both achiral and chiral HPLC and UHPLC method transfer services to suit a wide variety of projects.
Our HPLC and UHPLC method transfer services are performed by highly trained and experienced staff and are compliant with USP <1224> under Revalidation, i.e., the method transfer will consist of partial revalidation by the receiving laboratory. We offer two options for method transfer services, as described below, to provide flexibility based on your requirements.
Our team will review the relevant information and then draft a formal release specification for your review and approval. Once the production of your GMP API is complete, our Quality Control Department will analyze the material according to the agreed-upon formal release specification.
Moravek’s Quality Control Department uses state-of-the-art qualified instrumentation to perform accurate and reproducible analyses of GMP APIs. The instruments used for release testing are meticulously maintained and operated according to GMP-compliant standard operating procedures. All instruments used for release testing are qualified by a certified Field Service Engineer.
Our in-house GMP release testing options include:
- Radiochemical Purity
- Chemical Purity
- Molar Activity
- Molar Activity
- Residual Solvents
- Elemental Impurities
- Form (Crystalline, Semi-Crystalline, Or Amorphous)
- Particle Size Distribution
- Water Content
Moravek offers stability studies as part of GMP campaigns, which include secure storage and analysis with qualified instruments in a dedicated Quality Control laboratory. Stability studies are routinely performed on the radiolabeled product generated during the non-GMP technical batch, so that the stability data can be obtained before the GMP batch is completed.
There are a variety of benefits to performing a stability study on the technical batch product, including:
- Evaluating the stability of the radiolabeled product in the same dosing/storage conditions planned to be used for the GMP batch
- Testing multiple potential storage conditions for the GMP batch
- Informing decisions regarding the GMP batch dosing timeline and packaging
Our trusted GMP stability studies include:
- Stability chambers with 24/7 temperature monitoring
- Temperature options include controlled room temperature (+25 °C/60% RH), +4 °C, -20 °C, and -80 °C
- Aliquot preparation for all requested time points and storage conditions
- Analysis according to the approved stability study protocol
- All results and a final stability study report
- CoA with updated retest date (if applicable)
Our GMP stability chambers are continuously monitored by a 21 CFR Part 11 compliant Rees Scientific Environmental Monitoring System. The temperature is recorded in all chambers and the relative humidity of the +25 °C/60% RH chamber is also recorded. Periodic requalification of the stability chambers is carried out with Rees Scientific temperature mapping.
Results of stability testing are provided at each time point and a final stability report is provided at the end of the stability study to summarize the results over all time points. An updated retest date may be assigned if the material meets agreed upon stability criteria.