Analytics

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.

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

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.

One of the main purposes of stability testing is to establish shelf life for these drug products. The goal of this paper is to create an Excel spreadsheet, which can be used for statistical testing of more than three stability batches for poolability.

Using image analysis to characterize complex finished products is crucial in particle analysis.

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.

Pharmaceutical Technology Europe® spoke with Joren van der Horst from Luo Automation, a Dutch company focused on automated visual inspection solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

As new analytical technologies advance, insight into the twin-screw granulation process is growing.

Capturing the nuances of immune cell phenotype and function can be achieved using glycosylation analysis.

Bettersize US showcases their BeNano Series, Bettersizer 2600, and BetterPyc 380 instruments at the AAPS 2023 PharmSci 360 event.

Waters has launched OligoWorks SPE Workflow and Kits, which is aimed at accelerating the bioanalysis of oligonucleotides.