Biopharmaceutical Analysis

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.

Webinar Date/Time: Thu, Feb 22, 2024 11:00 AM EST

Webinar Date/Time: Wed, Feb 28, 2024 11:00 AM EST

Webinar Date/Time: Thu, Feb 8, 2024 11:00 AM EST

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.

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.

Webinar Date/Time: Wed, Dec 13, 2023 10:00 AM EST

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

Lonza’s new GS Effex cell line can help overcome the challenges of developing therapeutic antibodies with increased potency.

The 3M Harvest RC Chromatographic Clarifier, BT500 is the latest addition to the company’s chromatographic clarifier portfolio.

Webinar Date/Time: Tuesday, December 12, 2023 Session 1: 9:00 am EDT | 1:00pm GMT | 2:00pm CET Session 2: 1:00 pm EDT| 12:00pm CDT| 10:00am PDT

Webinar Date/Time: Mon, Dec 4, 2023 11:00 AM EST

Webinar Date/Time: Tue, Dec 5, 2023 11:00 AM EST

Webinar Date/Time: Thu, Dec 14, 2023 11:00 AM EST

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.