Biopharmaceutical Analysis

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.

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

Studies conducted by a team at Oxford Biomedica demonstrated that HIC can be used to effectively separate non-deamidated capsids from deamidated capsids.

Digital transformation is allowing for better handling, analysis, and protection of vast data collection.

NGS abbreviates drug discovery timelines.

This article explores a grouping strategy for therapeutic peptides incorporating theoretical and experimental methodology and results to define a practical and scientifically justified cleaning procedure.

In a non-exclusive licensing agreement, Ricoh will have access to ERS Genomics’ CRISPR/Cas9 genome editing technology to create novel disease models.

The agency has published final guidance documents regarding validation and development of analytical procedures.

There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

The addition of another amino acid recognizer as well as improvements in surface chemistry, reagents, and software expand the proteome coverage of Quantum-Si’s Platinum sequencing platform.

Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.

Strategizing a PK/PD study approach in early phase development facilitates a successful clinical progression.

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Roche will acquire select parts of the LumiraDx group related to that company’s point-of-care technology, which integrates multiple tests on a single instrument.

Developing cell-based potency assays for cell therapies requires meticulous coordination.