Biopharmaceutical Analysis

Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.

The companies collaborated to launch a new cell-based profiling service for biochemical assay.

The companies have partnered to launch Conjugated Polymer Nanoparticle (CPN) products for use in molecular imaging and R&D applications.

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

Andrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.

Sharing of bioprocessing know-how can help resolve pressing industry problems.

Flush solutions for liquid chromatography mass spectrometry (LC-MS) systems and ultrapure solvents for ultra-high-performance LC-MS systems from Thermo Fisher Scientific can minimize interference and maximize lab instrument uptime.

Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).

Shimadzu’s Imagereveal MS mass spectrometry imaging data analysis software can analyze large sets of data or simultaneously analyze multiple sets of data.

The acquisition strengthens Nelson Labs’ outsourced testing capabilities for the pharmaceutical and medical device industries.

The TSQ Fortis Triple Quadrupole Mass Spectrometer from Thermo Fisher Scientific offers fast, robust liquid chromatography-mass spectrometry (LC-MS/MS) analysis for clinical research laboratories.

The Lumis electron backscatter diffraction (EBSD) detector incorporates a large-format complementary metal oxide semiconductor (CMOS) sensor to enable higher sample throughput, higher resolution measurements, and precise phase identification.

An expansion of laboratory facilities in Geneva, Switzerland expands SGS services for high-order structure analysis.

The Alliance for Regenerative Medicine’s (ARM) report highlights major trends and metrics from the 2018 second quarter in the regenerative medicines sector.

More complex biologic samples must be evaluated to ever higher levels of specificity and sensitivity.

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.

FDA and ICH seek comment on new exposure levels for cadmium in drug products.

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

Process analytical technology tools have enabled manufacturers to monitor and control their production processes.

This article discusses affinity capture for tier determination and surveys a broad collection of commonly and less commonly used assays to analyze cell culture media

Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.

Process understanding and careful assessment of risks are essential in developing viral clearance programs.

Geofrey Wyatt has been named CEO and Clifford Wyatt named president of Wyatt Technology.

The company’s investment in new laboratory equipment and personnel will strengthen its cell line development services.