DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

• 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
• Guidelines For Proper Filtration And Delivery Of Samples To On-Line Process Analyzers

  Increasingly precise process control strategies, often linked to computer control, have accelerated the use of sophisticated on-line chemical composition analyzers in plant applications. Instruments such as gas and liquid chromatographs, ion chromatographs, laser optic instruments, atomic absorption instruments and specific ion analyzers, which were rarities in laboratories ten years ago, are now found routinely in plant settings. By Ken Perrotta, Division Engineering Manager

• 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

• Effect Of Sterilization On Mechanical Properties Of Silicone Rubbers

  Silicone rubber is widely used in the pharmaceutical industry where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products must be sterilized frequently and repeatedly by high level energy and/or chemical vapor in order to eliminate bacterial surface contamination.

• Comparison Of Five Cell Culture Media Demonstrating CHO Cell Culture Growth In Batch Or Fed-Batch Process For Commercial Operations

  This case study details a two month, four phase project to design chemically-defined feed media that improved two simulated batch processes utilizing products by SAFC, Life Technologies, Thermo Fisher Scientific, and Irvine Scientific. By Mark C. Arjona, Evan R. Horowitz, Alex A. Jurisch, Jenny Y. Bang, Tom Fletcher, Irvine Scientific

• Proven Long Life Lasers™ In Optical Particle Counters Optical particle counters (OPC) utilize light illumination and extinction to determine the presence, size, number and/or concentration of particles. Particles are typically suspended in a fluid or air, which flow through the volume that is illuminated and viewed by the detection system.