MANUFACTURING PROCESS SCIENCE/ TROUBLESHOOTING

BPS’s exclusive focus on the Biologics business means we are committed to remaining experts in not only the process engineering of the business but also in the scientific and technical nuances associated with the different unit operations. What that means for our clients is that they can turn to us for help when things are not going quite right with a new or existing process. This can range from improving oxygenation in a bioreactor to developing a modified column packing procedure to a new CIP procedure for a chromatography resin. The following is a list of some typical solutions provided.

Fermentation

• Design and development support for highly productive E. coli and yeasts (Sacchromyces and ) processes
• Consultation on inoculum train development
• Consultation on state-of-the art instrumentation such as cell density devices.

Cell Culture

• Design and development support for typical cell lines
• Roller bottle, perfusion, and “fed-batch” processes
• Cell separation by perfusion, depth filtration and centrifugation

Recovery/Harvest

Separation of mammalian cells by perfusion, settling, depth filtration and centrifugation

Harvesting of microbial cells via microfiltration, ultrafiltration and centrifugation

High pressure homogenization of yeast and E. coli cells

Cell debris removal by centrifugation and filtration methods

Purification and Virus Removal

Recovery of proteins and monoclonal antibodies with various ambient and cold temperature chromatography operations

ration via ultra-filtration

Buffer exchanges

Virus removal methods and strategiesi

Maintenance of low bioburden in-process batchesi

Virus removal with single filter systems and automated filtration skidsi

Bulk/Sterile Bulk Formulation & Filling

Formulation containers and storage methods

Preparation of Bulk and Sterile Formulated Bulk batches

Syringe and vial filing

Syringe and vial filing

Lyophilization

Buffer and Solution Preparation

Buffer preparation, dispensing (bag filling), storage and transfer

Media preparation, dispensing and sterile transfers

Sterile Processing, CIP & SIP Systems

Clean Utilities & Biowaste Inactivation

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