A 15-Minute Guide To Clinical Trial Document Management And The eTMF
This 15-Minute Guide describes the documentation challenges presented to pharmaceutical companies that outsource clinical trials to CROs. It covers industry adoption of the TMF reference model as the basis for electronic trial master files (eTMFs) — and how eTMFs improve document visibility and provide easy, secure access throughout a trial. Learn more.
By Ed Miseta, Chief Editor, Outsourced Pharma and Clinical Leader
Innovation is important in the pharmaceutical world. So much so, in fact, that it was difficult to find a booth at the 2013 BIO International Convention that did not seem to mention it in one form or another. New technologies and processes can often make or break a manufacturing firm. For that reason, contract manufacturer Aesica created the Scientific Advisory Board several years ago. Its purpose was to develop new technologies the company could take to customers. When Aesica realized others could innovate just as well, if not better, it disbanded the Advisory Board in 2011 and formed the Aesica Innovation Board (AIB). To continue to advance the efforts of the board, Aesica recently agreed to join process manufacturing think-tank Britest.
By Max Blomberg and Christian Julien, Meissner Filtration Products
The benefits of utilizing single-use systems (SUS) within the biopharmaceutical industry are well documented in the popular press and heralded at many conferences. At a fundamental level, they present exciting and often unprecedented opportunities in terms of increased productivity, the ability to make rapid capacity adjustments, and lower the overall costs of manufacturing. However, what an end user is effectively outsourcing when they choose to include single-use assemblies within a given process step, or, as the scope of their implementation broadens to include an entire process, must be considered. As single-use adoption has advanced from a curiosity to an implemented business reality for many pharmaceutical companies over the past decade, it’s relevant to explore a few key concepts that should be addressed.
By Dr. Hans-Walter Motzkus and Joe Gecsey
A particle counter is an electronic instrument that detects and counts airborne or liquid particles. Particles are detected using laser-based optical systems that shine a powerful light through a detection chamber.
By Chuck Reed, B.Sc/MS Director, Weiler Engineering, Inc.
Blow/Fill/Seal (BFS) product usage has been widely established in the ophthalmic and respiratory therapy markets for some time, and lately BFS technology has been gaining increasing worldwide acceptance in the parenteral drug marketplace, replacing traditional glass vial processing in a growing number of applications.
By Morgan Polen, VP of Application Technology, Lighthouse Worldwide Solutions
Environmental monitoring is an important aspect of regulatory and quality control in the production of pharmaceuticals. The manufacturing environment must be controlled and monitored during the production of drugs. Final drug products must be sterile and free from contamination.