Earlier guidelines such as ICH Q2(R1) and USP <1224>, <1225>, and <1226> viewed analytical method validation as a discrete activity focused primarily on chromatographic procedures. With ICH Q14, ICH Q2(R2), and USP <1220>, a life-cycle approach now considers variability and improves reliability, supported by tools like DoE, multivariate statistics, and digital technologies enabling Quality by Design and risk-based systems.
Virometix: US$15m for Synthetic Vaccines
Latest NewsSwiss biotech Virometix has raised US$15m in fresh funding to accelerate development of its lead pneumococcal vaccine candidate and advance its next-generation synthetic vaccine platform.
Antibodies: Cornerstone of ADC precision and efficacy
BackgroundAntibody-drug conjugates (ADCs) hinge on the antibody, not merely the payload or linker. Antibody precision defines efficacy, safety and therapeutic window. Emerging antibody formats – bispecifics, conditional designs and TCR-mimics – expand target space, demanding rigorous engineering to realise next-generation ADC potential.
Scripta Therapeutics raises $12m to flip the script on drug discovery
Latest NewsOxford-based techbio startup Scripta Therapeutics has emerged from stealth with a biology-first platform targeting the master regulators of disease.
AZ’s baxdrostat mets endpoint in resistant hypertension
Latest NewsAstraZeneca’s baxdrostat cuts 24-hour systolic BP by 14mmHg in resistant hypertension, offering a novel mechanism and major market potential.
AstraZeneca bolsters obesity portfolio with muscle‑preserving buy
Latest NewsAstraZeneca plc acquires SixPeaks Bio Inc to target muscle‑preserving obesity therapies, boosting its pipeline in a US$30 bn fast-growing weight-loss market.
From method validation to the life-cycle
BackgroundEarlier guidelines such as ICH Q2(R1) and USP <1224>, <1225>, and <1226> viewed analytical method validation as a discrete activity focused primarily on chromatographic procedures. With ICH Q14, ICH Q2(R2), and USP <1220>, a life-cycle approach now considers variability and improves reliability, supported by tools like DoE, multivariate statistics, and digital technologies enabling Quality by Design and risk-based systems.
Breakthrough study reveals stability key for mRNA
Latest NewsA landmark discovery by a team of South Korean scientists could transform the way RNA-based vaccines and therapeutics are developed and produced. Researchers led jointly by Professor V. Narry Kim and Professor Jin-Hong Kim have identified a series of viral RNA motifs that make conventional messenger RNA (mRNA) far more stable and efficient, potentially revolutionising RNA drug manufacturing.
Semaglutide and tirzepatide significantly improve heart health
Latest NewsSemaglutide (Ozempic®) and Tirzepatide (Mounjaro®) not only promote weight loss but also significantly reduce the risk of major cardiovascular events in patients with type 2 diabetes. Real-world evidence from the Technical University of Munich and Harvard Medical School shows up to 18% lower risk of heart attack and stroke, highlighting the growing potential of GLP-1 therapies in cardiometabolic care.
CDMO: An SAP S/4HANA transformation in <10 months
BackgroundIn Life Sciences, SAP transformations for midsize CDMOs are nothing short of complex. But integrating a newly acquired site into an existing SAP landscape is a different matter entirely. At Tenthpin, we took a bold step by designing a new SAP S/4HANA template from the ground up to a new site for a leading CDMO; and then successfully deploying it to another newly acquired site in less than 10 months.
Eli Lilly and Novo Nordisk slash obesity drug prices
Latest NewsEli Lilly and Novo Nordisk cut US obesity drug prices under Trump’s MFN plan, offering Zepbound, Wegovy and others via Medicare, Medicaid and LillyDirect.