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 Technologies
Read 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:
For inoculation train and production cell culture up to 1,000 Liters, the GE Healthcare Wave bioreactor and/or the Thermo Fisher Single-use bioreactor (SUB)
Specifications
Specifications
For chromatography control, the GE Healthcare Akta line of FPLC chromatography systems
Specifications
Specifications
For mammalian cell harvest, Pristine intends to utilize depth filtration technology or whatever the customer's preference may be.
Specifications
Specifications
In some cases Pristine may purchase pre-packed chromatography columns from a reputable subcontractor, such as Repligen Corporation.
In cases where this method is not appropriate, Pristine will pack columns on-site under cGMP conditions.
Specifications
In cases where this method is not appropriate, Pristine will pack columns on-site under cGMP conditions.
Specifications
1with the exception of centrifugation for cell harvest where depth filtration will be used instead
