Downstream Processing White Papers and Case Studies

1. 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.

2. 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.

3. Improving Aggregate Removal From mAb Feed Using Cation Exchange Chromatography

   Researchers in the field of chromatography have required ever more sophisticated and selective methods for removing aggregates from the monomer.

4. Improving DNA Removal from Bioprocess Purification Processes

   Many new biological drug products produced using recombinant DNA technology, such as monoclonal antibodies, are produced in cell culture. Because therapeutic proteins such as monoclonal antibodies are produced in cell culture, impurities can result from the host cells, or cell substrates. By 3M Purification Inc.

5. Sani-Tech® Ultra White Paper 6/29/2012

   For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion. 

6. 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.

7. Proven Long Life Lasers™ In Optical Particle Counters 12/1/2011
   Optical particle counters (OPC) utilize light illumination and extinction to determine the presence, size, number and/or concentration of particles. Particles are typically suspended in a fluid or air, which flow through the volume that is illuminated and viewed by the detection system.
8. 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.
    

9. 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.
10. Biomanufacturing Flexibility 12/22/2011

    This white paper from BIO-G looks at how to create flexible, agile manufacturing facilities to respond to the current glut of biomanufacturing capacity and industry consolidation. Future proofing these facilities for higher titers and multiple product lines is also explored.