Biopharmaceutical Analysis

Formulation and analytics are combining to advance drug development synergistically, with evolving tools and related strategies shaping quality, scalability, and innovation.

Advances in digital technologies offer effective data handling for bio/pharma manufacturing.

The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods. Manufacturers and diagnostic partners must collaborate to create innovative, compliant testing strategies that preserve product integrity, meet tight timelines, and deliver life-saving treatments faster.

Data integrity and quality are paramount for drug discovery, manufacturing efficiency, regulatory compliance, and patient safety.

The growing cell and gene therapy (CGT) market is driving demand for innovative, robust diagnostics to meet scaling, regulatory, and quality needs.

The agreement expands researcher access to backbone modifications that boost stability and delivery of RNA therapeutics across diverse applications.

The acquisitions include three testing laboratories that enhance Normec’s ability to serve key highly regulated sectors in the TICC industry.

At AAIC 2025, Roche presented new data from its Alzheimer’s disease research efforts across its diagnostics and pharmaceutical portfolios.

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.