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.
MitoRx Therapeutics advances next-generation obesity therapy
Latest NewsMitoRx Therapeutics Ltd has raised £5.5m in a seed financing to advance Myo‑004, a small molecule mitochondrial-targeted obesity therapy enabling fat loss while preserving lean muscle mass.
Sofinnova Partners surpasses target with €650m fund to back up early-stage biotech
Latest NewsSofinnova Partners has closed its new investment fund, Capital XI, at €650m, far exceeding its original target. The early-stage biotech and medtech-focused fund will invest mostly in Series A, but also seed financings of companies, including oncology, inflammation and immunology, CNS, and cardio-metabolic diseases.
Medicxi announces new €500m biotech investment fund
Latest NewsVC specialist Medicxi has closed its oversubscribed €500m Fund V to support existing biopharmaceutical developers, and creating new companies across all development stages.
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.