April 2011 Issue
Using physical material attributes allows for much tighter control of processes and product quality. Could a new excipient database be a model for pharma?
pH is a deceptively simple measurement; its control can be extremely challenging in both upstream and downstream biopharmaceutical manufacturing.
IT, Engineering, Lab? The answer under a consolidated system should be no one and everyone, says Patnis Jim Macdonell.
Reducing environmental impact may not have been vendors primary goal, but it has been a welcome result, allowing dramatic cost savings.
Theres nothing like a good tale of frugality to make your day.
Weve been tracking Twitter at recent pharma tradeshows, but most conference-goers have other things on their minds.
FDAs new guidance on process validation gets back to the original language of the GMPs on the subjects of control and sampling, Ali Afnan writes. After all, FDA never intended for three consecutive batches to satisfy either the spirit or the letter of the law.
At Pfizer, a co-design approach and enhanced information sharing between R&D and manufacturing is improving results.
The PQM program has launched a new public database of medicines collected and analyzed.
Excipients, many of them naturally derived, are a source of variability in drug manufacturing, as differences in processing and other factors can lead to significant differences in the properties and performance of materials of the same grade, not only between different vendors but from the same vendor.
A green chemistry and environmental expert talks about whether pharma is really as green as it thinks it is.
Process modeling and life cycle assessment are helping to gauge the environmental impact of single-use equipment.
Two magic wordsCost Savingcan engender support for green initiatives.
Continuous processing and bioprocesses deserve more attention, says GSKs Conchita Jimenez-Gonzalez, who chairs the ACS GCI Pharma Roundtable.
If it cant be measured, it cant be green; leading manufacturers are turning to advanced metrics to show just how sustainable their products, processes, and plants really are.
Interest in protecting the drug supply chain is becoming top of mind for drug manufacturers, technology providers, and governments as they begin to understand the current and elevated risks to patient safety.
At Marchs Interphex 2011 in New York, Chris Broome, senior engineer on Mercks global energy team, spoke about his company's global efforts to minimize energy usage, built upon participation in Energy Star programs.
Know when youre on shaky ground, and then respond promptly and thoroughly to FDAs requests, says J&J Janssens Patti Gupta.