Analytical Methods

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.

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

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.

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.

Tome Bioscience is facilitating the transition in biology from the editing phase to the cut-and-paste phase.

A single protein or gene expression product can exist in multiple proteoforms due to alternative splicing, point mutations, post translational modifications and endogenous proteolysis.

This collaboration will combine BigHat Biosciences’ AI/ML-guided Milliner platform with AbbVie's expertise in oncology and neuroscience to develop next-generation antibodies.

MilliporeSigma’s new platform combines generative AI, machine learning, and computer-aided drug-design aimed at increasing the success rate of new drugs and therapies.

Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.

TAU Systems plans to establish TAU Labs, a new next-generation, laser-driven plasma accelerator laboratory, in Carlsbad, Calif.

Under this multi-year collaboration, Genentech and NVIDIA will use AI to optimize and accelerate each company’s platforms to discover and develop innovative therapeutics.

Twist Bioscience now offers its Express Genes rapid gene synthesis service at its Wilsonville, Ore., manufacturing facility.

Matthew Lauber, senior director—Cell and Gene Therapy, Consumables & Lab Automation, at Waters Corporation highlights the company’s motivation behind their new bioanalysis kit for oligonucleotides.

Matthew Lauber, senior director—Cell and Gene Therapy, Consumables & Lab Automation, at Waters Corporation discusses the analytical and downstream purification challenges of oligonucleotides.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, talks about the differences in designing E&L testing for combination products vs. conventional pharmaceuticals.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, discusses the differences in how E&L study design should be approached based on whether the study is following ISO or USP standards.

Hollie Barton, senior director, Chromatographic Services, for the PPD clinical research business of Thermo Fisher Scientific, highlights one approach to ensuring the continuation of analytical expertise.

Hollie Barton, senior director, Chromatographic Services, for the PPD clinical research business of Thermo Fisher Scientific, discusses ways that labs are addressing the pressure of rapid analytical turnaround times.

Under the partnership, Sartorius will leverage SPARTA Biodiscovery’s technology to accelerate development of nanoparticles used for drug delivery.

Glycosylation analysis can provide a deep and nuanced understanding of immune cell phenotype and function.

CN Bio and LifeNet Health LifeSciences have teamed up to provide direct access to a portfolio of highly characterized hepatic cells for the creation of advanced liver-on-a-chip assays.

Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.