Manufacturing Process Science

Manufacturing Process Science

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) 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.

  * DIsposable bioreactors to 1,000L.

Cell Culture 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 E. Coli and east cells. 

  * Cell debris removal by centrifugation and filtration methods.

  * Harvest and recovery using disposable memrane and depth filters.

Purification and Virus Removal

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

  *  Concentration via ultra-filtration.

  *  Buffer exchanges.

  *  Virus removal methods and strategies.

  *  Maintenance of low bioburden in-process batches.

  *  Virus removal with single filter systems and automated filtration skids.

Bulk/Sterile Bulk Formulation & Filling

  * Formulation containers and storage methods.

  * Preparation of Bulk and Sterile Formulated Bulk batches.

  * 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.