A viable QMS cannot be based upon anything except data and records that are attributable, legible, contemporaneous, original, accurate, complete and easily retrievable.
Philip Lyman, PhD – Director of Process Simulation at CRB – discusses how a process model, at the right detail level and properly validated, can be an invaluable tool to compare alternatives and justify cost for manufacturing and manufacturing-related processes.
Modeling tool helps companies right size equipment for efficiency and savings.
How do you engage a client in a way that frees his/her mind to the prospects of an open flexible lab design? How do you lead them to see the potential within an old, tired building? Many of our clients, life sciences and otherwise, have antiquated labs in antiquated buildings on campuses that have been built to their limits.
We have been talking about Personalized Medicine for years. "Wouldn't it be better if the medicine that I was taking was designed just for me?" We all know that personalized medicine would greatly benefit individual patients.
A global specialty biopharmaceutical company entered into a public-private contract worth $220 million with the Biomedical Advance Research and Development Authority (BARDA) in 2012. Its primary goal was to establish a Center for Innovation in Advanced Development and Manufacturing (CIADM) to address challenges encountered in developing biodefense medical countermeasures.
There has been intense interest and emphasis being given to the continuous OSD manufacturing process as an alternative or addition to the traditional batch manufacturing process.
Learn how the application of best practice design principles can help mitigate the risks confronting biotechnology companies when navigating the uncertainty surrounding its product pipeline.
To ensure quality of pharmaceutical raw materials and products, it is very important to monitor specific factors throughout supply chain. In cold chains, temperature is closely controlled and monitored.
The age-old debate for mature, emerging and virtual biopharmaceutical companies remains whether to outsource production to a contract manufacturing organization (CMO) or not?
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