Biopharmaceutical Analysis

Mechanistic toxicity hypothesis is essential in guiding decision-making and predicting toxicities during the preclinical stages of drug development. The authors highlight the growing importance of integrating advanced technologies like mass spectrometry imaging into toxicology to enhance preclinical translation, foster innovation in therapeutic development, and ultimately improve drug safety and efficacy.

Advanced modeling provides greater understanding for more-informed decision making across all phases of drug development.

As development of novel drugs accelerates, enhanced downstream production processes maintain product efficacy, safety, and quality.

Quality, stability, sustainability, and the increased and thoughtful integration of artificial intelligence are foremost in the minds of those on the leading edge of testing trends.

This article provides an overview and introduction to the use of analytics in biopharmaceutical development and manufacturing.

The investment will be done over five years and will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple US states.

This paper outlines a systematic approach to detecting contamination through process deviations, including changes in % dissolved oxygen, pH, and metabolic patterns.

The shift toward personalized medicines poses new challenges in cleanroom protocols.

With up to 88 channels, the CytoFLEX mosaic Spectral Detection Module offers enhanced detection.

The authors examine the risks of extractables and leachables and present solutions that emphasize the importance of a strategic multi-prong approach.

Developers save money and time while accessing expertise.

Under this collaboration, GSK and Oxford will combine their complementary expertise in the immune system, vaccines, and cancer biology.

UK Biocentre will now utilize Azenta Life Sciences’ automated storage system, which gives the center storage capacity for more than 35 million biosamples.

With the launch of its cobas mass spectrometry solution, Roche brings fully automated mass spec analysis to the clinical lab.

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.

Fluorescence spectroscopy offers unique advantages for characterizing EVs.

The company will now include GMP cell-based potency assays at its Cambridge, UK, and San Diego, Calif., sites expanding its early and late phase analytical capabilities.

The new European facilities located in German, Italy, and Lithuania will specialize in drug discovery and R&D services.

Avantor has launched its new, expanded Innovation Center in Bridgewater, NJ, with integrated workflows under one roof and purpose-built collaboration spaces.

The expanded offices in Griesheim, Germany, feature a demonstration and training area.

The best strategy is to use a combination of complementary methods.

Contract organizations offer assistance for testing raw materials obtained from outside suppliers.

The new Vivaflow SU tangential flow filtration cassette is designed to be more flexible and user-friendly and offers enhanced ultrafiltration and diafiltration efficiency.

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.

As the field of bioanalytical testing evolves, it is important for drug developers to stay at the forefront of the advancements to ensure they remain competitive.

Freudenberg Medical now offers custom single-use assemblies to expand its offerings in silicone extrusion and molding for biopharma applications.

With the acquisition, Olink will join Thermo Fisher’s Life Sciences Solutions business.

Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

Chemify founder and CEO, Lee Cronin gives insight into the combination of digital chemistry, robotics, and AI in the drug discovery process.

Biosimilar analytical assessments focus on demonstrating biosimilarity and interchangeability with the reference biologic.