Downstream Processing White Papers and Case Studies

1. Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System 10/24/2013

   This application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in cultivations of E. coli and of modified Pseudomonas fluorecsens (P. fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.

2. Protein A Alternatives: Mixed Mode Resins For High Throughput mAb Feedstocks 8/16/2012

   Mixed mode resins can serve as an alternative to protein A in intermediate processing. Implementation of mixed mode resins can reduce water required for filtration and time  for column loading.
    

3. Automation Of A Homogeneous Proximity Assay For Detection Of Residual Protein A In Biological Therapeutics

   Protein A is used in affinity chromatography for therapeutic antibody purification and has been shown to leach from columns during purification of antibodies resulting in contamination. Residual Protein A in therapeutic drugs could elicit mitogenic or immunological reactions in patients.

4. Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications 6/10/2011
   Prior to creating an accurate economic model for TFF, a thorough understanding of the process where the TFF is used is needed. A process model is a valuable tool when properly executed and it must accurately include all critical aspects of the purification process. By Michael LaBreck, Mark Perreault, Novasep
5. Turning Data Into Information 12/22/2011

   As biopharmaceutical manufacturing has evolved from small-scale lab production in small flasks to massive commercial production in deep-tank bioreactors, an avalanche of production data has evolved to support it. From individual unit operation skids to distributed control systems and enterprise resource planning tools, biomanufacturing today is buried by the sheer quantity of data coming in from the manufacturing floor.

6. Optimized Sterile Filtration of Pharmaceutical Solutions 11/12/2015

   The cost of filtration and separation stages within the production of pharmaceuticals has been increasing along with the increased complexity of final drug products.

7. White Paper: Computrac® Moisture Analysis Made Simple 8/10/2011
   When people aren’t feeling their best they often turn to medicine for relief from the symptoms that are associated with being ill. The public trusts that the products by pharmaceutical companies will not only make them feel better but will also not have harmful side effects.
8. A Purification Strategy For Clinical-Grade Monoclonal Antibody 10/3/2016

   mAbs are currently the most important class of therapeutic proteins. Advances in upstream process technologies have led to tremendous improvement of mAb titers in mammalian cell culture. 

9. Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells 7/11/2011
   Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.
10. White Paper: Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells 7/11/2011
    Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.