Biopharmaceutical Analysis

Cytek Biosciences’ Northern Lights series of advanced flow cytometry systems brings reagent and application flexibility to more labs while enhancing performance.

Survey results and record attendance may show positive signs for established and emerging biopharma regions.

A project funded by BioProNET will investigate optimization for bioprocessing of gene therapy vectors using hydrodynamic fluid flow fields.

Research from Massachusetts Institute of Technology suggests that small chips could replace standard lab-scale spectrometry equipment for many applications.

The company added a new EUR 63-million (US$72-million) packaging center at its manufacturing site in Darmstadt, Germany.

Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.

The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.

By adapting techniques from other sciences-and exploring better tools for biologics drug development-researchers are addressing challenges of protein characterization.

The company says the new equipment will reduce sample turnaround times and increase variant detection quality and accuracy.

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.