Downstream Processing White Papers and Case Studies

1. Quality By Design In Biomanufacturing 12/22/2011

   QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.

2. Avoiding Drug Shortages With Microbial Detection 3/6/2013

   Over the past year, critical drug shortages used to treat a host of life-threatening illnesses have been making headlines. Microbial contamination has been cited as a major contributor to the shortage, yet the prevailing practices to ensure the safety of drugs have been slow to change. In most cases, quality assurance practices safeguarding the drug making environment continue to rely on periodic air and a culturing method from a prior century. By Aric Meares, President and CEO, BioVigilant

3. 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.

4. Determination Of kLa Values Of Single-Use Bioreactors 8/3/2016

   Because single use bioreactors offered by  manufacturers vary in parameters critical for oxygen transfer, they are often not comparable to each other and to conventional glass and stainless steel vessels.

5. Automated Bioluminescent ADCC Reporter Bioassay Using Bioengineered Jurkat Cells 2/10/2013

   Pharmaceutical companies are increasingly exploring new biologic and biosimilar products, and thus increasing monoclonal antibody (mAb) immunotherapeutic research. By Tracy Worzella, Promega Corporation and Brad Larson, Applications Department, BioTek Instruments, Inc.

6. 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.
7. Best Practices For Process Scale Column Packing Of CHT™ Ceramic Hydroxyapatite Media

   CHT ceramic hydroxyapatite media require specific considerations during process-scale chromatography packing due to high specific gravity, rapid settling rate, and sensitivity to mechanical shear.

8. An Automated Profiling Application For G9a Histone Methyltransferase And Bromodomain Proteins

   Due to several findings, G9a and BET bromodomain proteins have become the target for numberous drug discovery projects. In this study, we describe a novel, cell-based assay platform that uses the robust, yet simple Enzyme Fragment Complementation (EFC) Technology.

9. Removal Of Host Cell Proteins During Monoclonal Antibody Purification

   Protein A chromatography is a widely used and highly successful method of purifying recombinant monoclonal antibodies. However, since Protein A has high affinity for antibodies, harsh conditions such as low pH are often required to elute monoclonal antibodies from Protein A affinity columns. By 3M Purification Inc

10. 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