The term live biotherapeutic product (LBP) refers to products containing whole, live microorganisms, such as bacteria or yeast with an intended therapeutic or preventive effect in humans, regardless of the route of administration (oral, topical, etc.).
The development approach of SynCo for a LBP consists of culture expansion, propagation, harvest, and purification. Before the development starts a list of potential critical process parameters used to control the process will be prepared. During the actual development these parameters are verified and the process will be scaled-up to the final production scale.
SynCo has specialist experience in working with LBPs, which involves the development of scalable and fully closed aseptic production processes. As a world leader in this field, we are able to offer both bulk drug substance (BDS) and drug product (DP) production (including lyophilization) in our facilities in Amsterdam. SynCo is currently also working on implementing sachet filling for LBPs.
If you are interested in learning more about SynCo's process development services, please do not hesitate to contact us or to download our factsheet.