In pharmaceutical industry, process development is essential for new drug manufacturing from laboratory to commercialization. Not only the batch size needs to be scaled up but also the process, equipment, and environment should be compliant with PICS/GMP regulatory requirement to ensure the product meet specifications with high quality. As a reliable partner, Amaran can assist clients to establish and complete new drug process development. Amaran’s professional team of extensive experience and good communication, together with high-quality manufacturing environment qualified equipment and state of the art facility is to the success of your product and company. Amaran will conduct following tasks when we receive your inquiry.
- Carbohydrate Synthesis
- Thiolation & Conjugation of Protein
- Protein Purification
Process Development Capacities
- Expert processes development and optimization during “Clinical Stages”
- Cooperate with strategic partners to develop robust & cost effective process for “Commercial Stages”
Technology Transfer and Assessment
Amaran will provide assessment of the project and prepare the plan before the implementation of the transfer, and reach an agreement with clients. Amaran collaborates with clients to implement technology education, training and necessary validations.
Test Runs and GMP Runs
Amaran will execute several production runs to access the feasibility of process, and assist clients to establish CQAs and CPPs. If any events occur during manufacturing, Amaran will collaborate with clients to come up with the best solutions.
Upon completion of test runs or GMP runs, Amaran will provide campaign reports with detail executed procedures, parameters and suggestion for future development.
Currently, Amaran has successfully performed process development of two products, a plant extract from purification and lyophilization process and a synthetic carbohydrate-protein conjugation product. Amaran is your reliable partner to perform process development.