DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

• Automated Bioluminescent ADCC Reporter Bioassay Using Bioengineered Jurkat Cells

  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.

• Materials Of Construction For Biopharmaceutical Water Systems

  Stainless steels are uniquely qualified for bioprocessing applications not only because of their long service life, availability, and fabricability, but also because they are non-corroding, non-contaminant, can be polished to very smooth finishes, are strong and rigid, can withstand heat and chemical sterilization treatments, and are easily welded. By Michelle M. Gonzalez

• Mammalian Virus Purification Using Ceramic Hydroxyapatite

  Conventional techniques for mammalian virus purification produce variable quality, quantity, and significant loss of particle infectivity. We  propose the chromatographic separation of viral particles of diverse sizes and from different families such as dengue, influenza, mouse hepatitis, adenovirus, poliovirus using CHT Ceramic Hydroxyapatite resin.

• Avoiding Drug Shortages With Microbial Detection

  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

• 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.

• White Paper: Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications 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