06.14.25 -- Bioprocess Online Best Of May

Don't miss the next Bio-Expo Live! This interactive, multi-day event is organized by stages of drug development and production, making it easy to find sessions tailored to your company's needs. Browse the full agenda and register for free to join the conversations most relevant to your work.

First due at the end of 2025, the act has been delayed until late 2026, which suggests key issues that many say hobble innovation will go unaddressed for longer.

The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.

Consider these strategies for meeting quality and regulatory requirements in cell and gene therapies that can also help to identify issues early, reduce risks, and prevent delays and rework.

Technological advancements are driving significant change in biomanufacturing. An industry expert highlights three pivotal areas: data science, advanced automation, and process analytical technologies.