Pristine Bioproduction: GLP Manufacturing Technology.
Pristine Bioproduction is a contract manufacturing facility specializing in the GLP production of biological drugs such as monoclonal antibodies for pre-clinical studies such as supply for animal toxicology batches. Pristine will also provide bioprocess development services for both cell culture and purification. Pristine can support a GLP run rate of approximately 1 batch per month. Based on demand, Pristine will support flexible scale-up. Pristine achieves scale and keeps cost down through the use of disposable technologies.
Benefits of Disposable TechnologiesRead more about disposables
- Ability to truly close the process stream from the environment.
- Eliminate cleaning in place (CIP)
- Eliminate steaming in place (SIP)
- Reduce/eliminate bioburden problems
- Facilitates parallel processing because of built-in segregation of production line
- Rapid changeover from one batch/product to the next
- Reduce the need for ISO air classification and expensive HEPA air filtration.
- Allows operation in CNC "warehouse" space
- Reduces labor by eliminating the need for air sampling and cleaning validation.
Technologies Used By Pristine Bioproduction (with approval of the client's process development staff)
- Antibody Production and Process Development. Process flow is based on the proposed platform1 antibody process as described by Brian Kelley, et al in http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2759494
- Unit Operations. Pristine uses off-the-shelf equipment including the following:
In cases where this method is not appropriate, Pristine will pack columns on-site under cGMP conditions.
1with the exception of centrifugation for cell harvest where depth filtration will be used instead