API scale-up and manufacturing
Overcoming drug development challenges from the synthesis of a molecule, our Active Pharmaceutical Ingredient (API) production services are critical to drug development around the world. Underpinning our complete suite of services, our API development and manufacturing is delivered by an expert team, with exceptional knowledge in state-of-the-art facilities.
We partner with our customers to guide and support a process designed to maximise efficiency and effectiveness.
Our completely integrated API contract manufacturing service includes process development studies and scale-up activities to manufacture the API needed for pre-clinical and clinical studies up to Phase III and niche commercial products.
We also offer analytical and regulatory services essential to supporting critical development milestones in drug development, from pre-clinical and clinical testing to regulatory approval. We can produce data that can be used in regulatory submissions in support of the initial phases (IND, IMPD) or late development phases (NDA, MAA).
Following the "fit-for-purpose" or "full development" approach, or any other customer model, we will select a process suitable for the scale-up. Parallel Experimentation and Design of Experiment (DoE) approaches are used routinely for the definition of the best reaction conditions in the shortest timeframe. In addition, the following activities in support of the process selection are performed:
- Synthesis of impurities and markers
- Purification of analytical standards
- Synthesis of stable isotope labelled materials
- Spiking and purging studies to demonstrate the fate of the impurities and define the API and intermediates specifications
We are also experts in Technology Transfer of the processes developed to other pilot or manufacturing plants.
After the process is optimised, it can be scaled-up in the Aptuit pilot plant facilities. Our pilot plants in the UK and Italy can prepare API according to cGMP to support different project phases. These plants can prepare batches ranging from 1-2 kg up to 120 kg.