DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

• 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).

• Determination Of kLa Values Of Single-Use Bioreactors

  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.

• 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

• 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

• Accelerating Biopharmaceutical Development From DNA To Drug

  In the last decade, single-use solutions for virtually every bioprocess unit have been developed, and considerable investments have been made by the industry into areas that underpin this technology.

• Global Biochemical Profiling For Bioprocess Optimization

  It is widely understood that the production phase of bioprocessing can have a significant impact on the overall profitability of the biopharmaceutical.