GMP CUSTOM INGREDIENT DEVELOPMENT
A&C can fulfill the need for custom or novel excipients or raw materials through a practical process development approach based on proven strategies for purification, such as distillation and crystallization. We offer GMP custom ingredient development and GMP manufacturing by generating robust, practical and cost-effective processes for the preparation of pharmaceutical ingredients.
Our R&D team has over fifty years of experience in problem-solving and is highly skilled at the timely development of scalable processes that focus on simplicity, robustness and suitability for purpose. Throughout the years, we have provided drug delivery solutions to pharmaceutical and biopharmaceutical companies worldwide.
A&C utilizes one of the world’s leading project management tools to provide cost-effective and timely solutions for all of our partners. Our project management tool allows real time data regarding progress on their projects to be accessed by our customers 24/7.
Should a customer require specific excipients or other raw materials to be manufactured within a fully compliant GMP process, A&C offers this service with transparency and will provide full supporting documentation.
All products will be supplied with a full dossier of documents to support your regulatory filings and Drug Master Files (DMFs) are available upon request for select products. A&C has been offering customized GMP manufacturing of excipients, raw materials, buffers and APIs for over five decades to satisfy our customers’ requests. If your company needs a specific formulation, purity, pH level, custom packaged and tested GMP product, we are specialized in providing tailored solutions through an innovative and highly personalized approach.
If you have a special request for a custom excipient or raw material, Contact Us
A&C’s GMP custom ingredient and GMP manufacturing process is composed of 5 main phases:
1. Initiation phase
During this phase all of your specific needs for the customized excipients or raw materials are described and verified with our capabilities. This will already involve extensive communication between our respective departments. We will move to the next phase when we have established a joint fit.
2. Development phase
A dedicated project team will initiate small-scale development to meet your needs. You will receive development-phase raw materials for your internal evaluation. This phase may include multiple steps to achieve the desired result. After your approval we will move to the upscaling phase.
3. Upscaling phase
The development-phase product is handed over to our Process Development Department for large-scale production trials. You will assess if this trial product still meets your requirements. Small adjustments based on your evaluation can still be incorporated in this phase.
4. Validation phase
In this phase, the manufacturing process is validated according to our internal procedures based on GMP manufacturing standards. Upon successful completion of our validation and clearance of this product, you can use it for your commercial production.
5. Commercial phase
The newly developed excipients or raw materials are embedded in our regular organization and will be supplied according to the agreed conditions.