November 22nd 2024
The company has expanded its early and late phase analytical capabilities by including GMP cell-based potency assays at its sites in Cambridge, UK, and San Diego, Calif.
November 21st 2024
There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
Statistical Tools to Aid in the Assessment of Critical Process Parameters
There are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).
US Regulators Permit Kannalife Sciences to Import Cannabidiol for Feasibility Studies
March 2nd 2016The US Drug Enforcement Agency (DEA) has granted permission for the import of pharmaceutical-grade cannabidiol to Catalent Pharma Solutions for a feasibility study in conjunction with Kannalife Sciences, according to a company press release.