Analytics

A statistical analysis for determining an expiration date can be applied to replicates or their corresponding averages as suggested in industry guidelines.

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

Bari Kowal, senior vice-president, head Development Operations & Portfolio Management, Regeneron, discussed the utility of AI and how it can benefit R&D work.

The separation of deamidated capsids from non-deamidated capsids can be achieved using HIC, according to studies done by a team at Oxford Biomedica.

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

In this exclusive Drug Digest video interview, Chris Spivey, Director, Industry Relations and Strategic Partnerships, talks with industry experts about various aspects of drug product stability testing.

Jay Rajagopalan, senior director—Engineering & Product Management for Malema at PSG Biotech, shared insights at on how current industry trends are shaping the development and advancement of sensor technologies.

What are the lessons gleaned from a product’s E&L lifetime?

Ricoh aims to create novel disease models for R&D using ERS Genomics’ CRISPR/Cas9 genome editing technology.

FDA 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.

This discussion explores how the management and analysis of vast data generated by advanced analytical technologies are revolutionizing the drug discovery and development process within the biopharma industry.

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.

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Effective analytics will eliminate failures, deviations, and non-conformances.

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

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

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.

Analytical methods and tools play a pivotal role in cleaning validation.

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

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.

Image analysis is crucial for particle analysis of complex finished drug products.

Best practice methods for the tech transfer of CGTs can increase process and analytics robustness while remaining scalable.

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

By taking a strategic and evidence-based approach, companies can leverage the insights gained from stability studies to establish robust labeling.

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.

MilliporeSigma has expanded its biosafety testing laboratories in Shanghai, China, with the completion of new lab space at its new €29 million (US$43 million) Biologics Testing Center.

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