A technical batch synthesis can be performed under good laboratory practices (GLP) prior to a full-scale synthesis under current good manufacturing practices (cGMP). Moravek’s expert chemists perform technical batch syntheses on 14C-labeled active pharmaceutical ingredients (APIs).
Technical batch synthesis services include the production of your 14C-labeled API under GLP conditions, so that the production steps can be tested and finalized. Then, using information from the technical batch synthesis, a detailed batch record will be developed for the cGMP production of your 14C-labeled API. The batch record provides reassurance that your 14C-labeled compound will meet your deadlines and specifications, and all regulatory requirements. You can be confident in your 14C-labeled API because of Moravek’s technical batch synthesis services.
There are a variety of benefits to our technical batch synthesis services, including:
- Ensuring that the synthesis can be carried out to completion, providing material at the level of purity the cGMP specifications will require
- Resolving any problematic issues that may arise during synthesis, purification, and/or analytical phases of the project.
- A Production Batch Record may be produced based on the documentation of the technical batch.
- Stability studies may be performed on the technical batch product to determine stability and the proper storage conditions of the labeled compound prior to producing the cGMP material.
If you have any questions about our technical batch synthesis services, contact our experts today or fill out our form to request a quote.