DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

• Protein A Alternatives: Mixed Mode Resins For High Throughput mAb Feedstocks

  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.
   

• A Disposable Valve For Process Chromatography

  This case study discusses the need for a fully automated, disposable chromatography system which was PLC controlled and designed for use in a cGMP environment. The required applications for the chromatography system included contamination removal, and concentration and purification of biologically derived proteins used in the production of research and clinical materials. 

• 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

• Selecting The Optimal Resins For The Process Purification Of Native And Recombinant Proteins

  Native and recombinant proteins are used in a variety of applications ranging from drug discovery to target validation to high-throughput screening. Due to this, large-scale protein production and purification have become major necessities in industrial settings.

• 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

• 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