Analytics

Investment at SGS’s Mississauga, Canada facility provides for analysis of molecular interactions in real time.

The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.

Experts discuss some of the emerging trends in bioprocessing in 2016, including 4D bioprinting, 2D-NMR, and the CAR-T design space.

Instruments are introduced for elemental impurity analysis and materials identification.

The agency published guidance on data integrity as it is relates to CGMP compliance.

By focusing on laying strong technology foundations, pharmaceutical businesses can make informed decisions, equip themselves with the capabilities to eliminate threats, and future-proof operations.

Texture analyzers can be used to evaluate wall hardness and elasticity of softgel capsules.

A program for calibration and routine testing of weighing instruments ensures accurate results.

Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.

Thermo Scientific TruTools chemometrics package extends the capabilities of the portable TruScan RM Raman Analyzer.

The author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.

The author discusses issues and best approaches for solid dosage form pharmaceuticals.

Standardized testing protocols are crucial for acceptance of single-use systems.

The Spark 20M multimode microplate reader has the ability to read 6- to 1536-well microplates and includes a high-frequency xenon flash lamp that can be combined with detection modules.

The Zeiss Smartproof 5 wide-field confocal microscope is designed for applications in quality assurance and quality control, production, and R&D laboratories.

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.