Successful products require well defined, robust, scalable and reproducible processes that are commercially viable and regulatory compliant.
Our team has extensive expertise in all aspects of upstream and downstream development. The first step which is called Feasibility Study is to optimize the genetic codons, make the construct, establish a stable cell line, then express and purify the target protein for functional testing. The feasibility study ensures a smooth transition from process development to cGMP manufacturing campaign. The feasibility study is performed using the same clean room, materials, personnel, equipment, and batch records that will be used for cGMP manufacturing campaign. This will approximately take us 3-4 months. Then you may start the preclinical animal study with the sample provided. This will significantly save your time.
In process development phase, Profacgen have three segregated development suites which imitate the cGMP suites for the dedicated applications.