06.09.14 -- Moffitt, OSU Form World's Largest Cancer Research Partnership; Adaptimmune Collaborates With GSK
Quality Management: How Much Are Vendors To Blame? By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.
Biopharmaceutical manufacturing is one of the most demanding industries on its suppliers: demanding that its vendors be prequalified as primary or secondary, and requiring confirmations of product provenance, certificates of analysis, and other sometimes onerous documentation. All of this is done for drug product quality and consistency.
Q&A: What Are The Current Drivers And Directions In Bioprocess Monitoring? By William Whitford, Thermo Fisher Scientific What are the issues in bioprocessing monitoring? Accurate, timely, and nonperturbing monitoring of bioprocesses has always been of interest. Drivers of this begin from the need to know as much as possible about the state of the cultured cells, their environment, or the process during development and optimization. PAT-inspired process monitoring also provides increased process understanding in development and better control in manufacturing. A number of both classic and brand-new needs demand that we better understand what's going on within the bioreactor. Concerns in bioprocess monitoring begin with all the standard issues of accuracy, precision, and linearity. But, current bioprocessing quality initiatives and process developments are presenting additional demands.
Case Study: Transporting Cleanroom Components By Air Freight By Envirotainer
In end of 2013, NuFlare was challenged with the task of transporting a highly sensitive objective lens used in semiconductor manufacturing from Japan to Germany. The lens had been produced in a cleanroom environment and any exposure to normal conditions would quickly ruin the lens. This meant that the requirements for temperature, vibration, and humidity exposure were strict.
Marken has trained professionals with global expertise to protect and manage the logistics of biological assets including sensitive drug supply, study specimens with expertise in tissue, ambient, refrigerated, and frozen assets.
ArtProof is the world’s first 64-bit artwork inspection solution for Mac and Windows environments. Developed for printer, prepress and graphics industry users, ArtProof inspects artwork with pixel precision, dramatically increasing packaging accuracy while reducing inspection times.
VeriPac inspection systems utilize an ASTM-approved vacuum decay leak test method recognized by the FDA as a consensus standard for package integrity testing. This ASTM method was developed using VeriPac leak test instruments and has proven its capabilities under GMP regulatory guidelines.
In this webinar you will learn about the Emphaze AEX Hybrid Purifier — a multimechanism clarification device that embodies the philosophy of innovation necessary to transform and redefine the mAb purification process.