As biologic drug formats grow more sophisticated, scalable success depends on embedding manufacturability, analytics and quality thinking into molecular design from the very beginning of development.
As chemotherapy use declines and targeted therapies assume a larger role in cancer treatment, researchers are looking beyond response rates to focus on real-world feasibility and reducing treatment burden for patients.
Regulatory predictability has become an increasingly important factor in determining where clinical development takes place. Drawing on lessons learned from delivering complex programmes across Europe, Regeneron’s Dr Muriel O’Byrne explores how greater consistency can help sponsors maximise value.
As patent cliffs threaten hundreds of billions in drug revenues and M&A activity reshapes the industry, the companies best placed to capitalise on pharma’s great reshuffling will be those that have standardised their manufacturing operations, unified their asset management and integrated quality systems capable of satisfying an increasingly demanding multi-regulator environment.
Chiesi advances its carbon-minimal inhaler programme with European regulatory submissions for next-generation HFA-152a pressurised metered-dose inhalers.
General chapter 2.5.46. introduces a single HPLC-UV method for simultaneous determination of seven plastic additives, streamlining compliance for pharmaceutical packaging materials.
Winners of this year’s awards will be revealed during the opening of CPHI Milan 2026.
Milestone shifts how global pharmaceutical manufacturers approach post-approval life cycle management for medicines.
Pharmaceutical quality control laboratories face growing pressure to strengthen data integrity as regulators scrutinise incomplete records, manual data entry, and disconnected systems.
In this webinar, Particle Measuring Systems will share a case study of a biopharmaceutical company developing and applying a structured global rationale for the implementation of continuous viable environmental monitoring with a single-use microbial impactor within aseptic manufacturing environments.
Join USP to explore the latest approaches to organic impurity analysis and scientific solutions to support pharmaceutical quality, including regulatory expectations and practical applications of the USP Reference Standards.
Manual sampling cycles leave bioreactor control decisions hours behind culture dynamics. Process Raman spectroscopy offers continuous, real-time measurement of critical parameters, enabling true closed-loop control in perfusion and continuous bioprocessing applications where measurement lag directly impacts yield and product quality.
The biopharmaceutical industry has embraced Pharma 4.0 concepts, but the measurement infrastructure required to realise autonomous facilities and continuous bioprocessing remains underdeveloped. Process Raman spectroscopy offers continuous, non-destructive monitoring at frequencies aligned with cell culture dynamics, bridging the gap between control system capabilities and available data.