Analytics

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).

The 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.

The advanced capillary electrophoresis system, Maurice, from ProteinSimple is used for the quantitative analysis of identity, purity, and heterogeneity profiles of biopharmaceuticals.

The Tacta range of pipettes handle a range of volumes and liquids.

The Medifuge small benchtop centrifuge from Thermo Scientific provides versatility within a compact footprint.

Multiple data-integrity violations results in FDA warning letter for Mumbai, India-based Ipca Laboratories.

Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.

Performing a measurement uncertainty calculation is often seen as problematic.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Keith Moore, vice-president of analytical services, Metrics Contract Services discusses gains use in dissolution testing.

Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

FDA issued a warning letter to Zhejiang Hisun Pharmaceutical Co., Ltd., as a result of inspections that took place on March 2–7, 2015 at the Taizhou City, Zhejiang Province, API manufacturing facility.

Sensaphone's monitoring system provides low-cost, 24/7 remote monitoring of unattended freezers and coolers.

An ultraviolet light (UV) spectrophotometer system from Hanson Research automatically handles samples for pharmaceutical dissolution and diffusion testing.

The Prominence-i LC-2030 LT is a new model of Shimadzu’s i-Series integrated high-performance liquid chromatograph and ultra high-performance liquid chromatograph systems.

Mass Spec Lab, a privately owned analytical company, announced its official launch on Dec. 28, 2015 in Southern California.

Shimadzu’s Nexera MP UHPLC Front End system for LC/MS is perfect for LC/MS analysis conducted in pharmacokinetics and synthesis stages in drug detection processes. read more

Analytical methods and functional assays are used to compare molecules and relate characteristics to quality attributes.

KnowItAll spectroscopy software from Bio-Rad Laboratories corrects differences in spectra data.

Charles River offers the Endosafe nexgen-PTS endotoxin testing system.

Agilent Technologies and Thermo Fisher Scientific exchange instrument control drivers and software support.