|API SYNTHESIS & MANUFACTURING|
Cynthia A. Challener
Confidence in the quality systems and scientific competence of the API manufacturing team is essential.
read more
|CLEANING PROCESSES|
Elizabeth Rivera, Dijana Hadziselimovic
Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.
read more
|CONTINUOUS MANUFACTURING|
Jennifer Markarian
Flexible batch sizes can optimize supply, but equipment and processing challenges are still being addressed.
read more
| PEER-REVIEWED RESEARCH |
Chintan Patel, Sanjay Bandyopadhyay, Gayatri C. Patel
It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.
read more
| ANALYTICS |
Felicity Thomas
Characterizing particles and understanding bulk powder behavior is critical to get the best pharma product.
read more
|OPERATIONS|
Derek Gallo, Sanjay Konagurthu
Successful technology transfer depends on the ability to anticipate risks and plan ahead.
read more
|SUPPLY CHAIN: RAW MATERIALS|
Rita C. Peters
Supplier vetting and monitoring—plus comprehensive testing—ensure quality of raw materials.
read more
|QUALITY|
Agnes Shanley
Moving from paper-based to digitalized processes is the first step to enabling quality management and manufacturing to work in sync.
read more
|FROM THE EDITOR|
Rita C. Peters
Better drug design and patient education may promote improved personal and public health.
read more
|US REGULATORY WATCH|
Jill Wechsler
FDA is moving to shift industry away from step-wise batch production.
read more
|ASK THE EXPERT|
Susan J. Schniepp
A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
read more
|
