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This week’s biopharma news highlights formulation stability testing, automation in analytics, and achieving regulatory compliance.

Eric Hill, Chief Scientific Officer, BA Sciences, discusses the analytical challenges involved in conducting E&L testing for biologic drug products.

FDA’s newly introduced review route enables faster clearance of custom genetic and cell treatments, reshaping rare-disease development and manufacturing strategies.

Reliable bioanalysis and regulatory-compliant study design enhance drug development, says Alturas’s Sara Underwood at AAPS PharmSci 360.

The agreement centers on a worldwide, exclusive license to develop and commercialize enzyme replacement therapies using the proprietary platform technology.

At AAPS PharmSci 360, Kelly Donovan says tailored analytical strategies are necessary for reducing development delay risks.

At AAPS PharmSci 360, Ely Porter, PhD, says automated platforms enhance drug production velocity and assay excellence.

At AAPS PharmSci 360 2025, Siddhant Sojitra, Alexion, defines an agitation model to reliably test stability for early-stage biologics.

Performance advantages are driving adoption of membrane chromatography for advanced therapy purification.

Financing strategies for new modalities and AI will be central at PharmSci 360, shaping how advanced therapeutics move toward global patient access.

Novel biologics, from ADCs to in-vivo cell therapy, drive AI-enhanced quality control and supply chain flexibility in global biopharma innovation.

A new Cue Biopharma–ImmunoScape partnership seeks to advance targeted TCR-T expansion for solid tumors, supporting broader access and improved clinical durability.

In Episode 28, Miroslav Gasparek, Sensible; Lizzy Lawrence, STAT; and Joe Lewis, Deloitte, go behind the headlines.