DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

• 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.

• 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.

• Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media

  Monoclonal antibodies (mAbs) remain a predominant class of therapeutic protein products on the market because of their wide range of applications in disease treatment and diagnosis. Over the years, upstream technology advancements have helped improve the titer of target antibodies, from merely 1 g/L two decades ago to 10–13 g/L in fed-batch processes and up to 25 g/L in perfusion cultures today (Gronemeyer et al. 2014).

• Connection Technology Advances Closed System Processing

  The global demand for new biologics and vaccines, combined with the growing emergence of biosimiliars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective. By John Boehm, Colder Products Company

• Sani-Tech® Ultra White Paper

  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. 

• Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System

  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.