Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development. In this episode of PharmTechâs Pharma Fundamentals series, Dr…
A novel antibody therapy has strengthened the immune system’s ability to fight cancer in mice by targeting immune-suppressing cells more precisely than previous approaches, according to new research. The treatment, developed by Baomei Wang and colleagues at Genentech, targeted regulatory…
Quality is no longer viewed simply as a compliance function. Across pharma manufacturing and CDMOs, quality leaders are increasingly focused on building connected, data-driven organizations capable of preventing issues before they occur. At the same time, digital transformation and AI…
A new review of primary biliary cholangitis (PBC) has highlighted how interactions between immune cells and bile duct cells drive chronic inflammation, potentially leading to more personalised treatments. PBC is a chronic autoimmune disease that destroys small bile ducts inside…
Removing SRC-3 from regulatory T cells reduced tumour immunosuppression in preclinical models, allowing cytotoxic T cells and natural killer cells to infiltrate tumours. Dr David Lonard and Dr Sonal Gupta discuss how altering Treg activity could restore anti-tumour immunity. Regulatory…
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data. The guidance builds on the Plausible Mechanism Framework, which allows for a well-supported mechanism of action to serve as…
Pauric Bannigan, Intrepid Labs, explains how physics-informed machine learning aids formulation and why regulators still want experimental data. Pauric Bannigan, PhD, CSO and co-founder of Intrepid Labs, connected with PharmTech at AAPS PharmSci 360 2026 to discuss how computational tools are changing…
The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis. FDA published draft guidance on July 11, 2019 for... FDA published draft guidance on July 11, 2019 for sponsors of new drug applications and biologics license…
Equipment and Processing Report New methods of encapsulation and filtering address scale-up challenges. Microencapsulation is a promising drug delivery technology in which APIs are encapsulated with a natural or synthetic material that targets delivery by controlling the API’s release. Microsphere…
The authors revisit their previous effort to refine the terms that describe interventions and to dispel confusion that arose after the original article was published. The frequency of inherent interventions is largely fixed by external factors and not subject to…
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