Many start up companies aiming to develop an LBP have in house capability to do process development, yet often they lack the know how to do this in such a manner that the process developed can easily be transferred to a CMO to manufacture clinical material. Also, the QC assays needed to QA release a GMP batch for use in a clinical trial need to be defined early on. Since BioLyo has significant experience in providing consultancy for process and analytical development projects, we offer clients on or off site consultancy for their project, looking at the existing data and guiding the process and analytical development. This is considerably more cost effective for the client than outsourcing the entire program, while a tech transfer to BioLyo for GMP manufacture would be seamless, i.e. there is a mutual benefit.
Consultancy for Process Development & GMP Manufacturingadmin2021-09-24T16:24:53+00:00