In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs.
“Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP).
This white paper, brought to you by Dassault Systèmes BIOVIA, discusses the different types of external collaborations research organizations engage in, the reasons that many of these partnerships fail to meet expectations, and an informatics solutions to overcome these issues.
Everything pharmaceutical manufacturers want to know about risk in supply chain logistics but are afraid to ask. What are the rising trends impacting security of product in transport? When and where does risk mitigation become mission critical? And — perhaps the most burdensome — how can I be sure?
Issues of high viscosity and/or high volume are associated with biologics. Biologics cannot be taken orally and must therefore be delivered via an injection.
This white paper outlines how connectivity and comprehensive automation solution can facilitate technology transfer and scaling from process development to final manufacturing scale.
What started out as a simple bag for holding buffers or cleaning solutions has evolved to thousands of single-use products and entire processes. The industry is now calling for standardization.
Contamination in the manufacturing process can be a rare but catastrophic event costing a company millions per contamination in clean-up costs along. This does not include any loss of revenue due to missed product sales or the impact to the patient population due to loss of drug supply. Even with the use of animal origin free and animal component free systems, there have been recorded contaminations of CHO cells by Minute Virus of Mice (MVM) also called Mouse Minute Virus (MMV).
Today’s chemical development labs are busy places that create fascinating new chemicals, new formulations and new products that boost the bottom line. But are these labs as efficient as they could be?
Given the ever-increasing amounts of information being generated by systems, applications, and measurement tools, a strategic approach to managing information is a requirement, not a luxury.
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