08.09.25 -- Best Of July: Nitrosamine Reporting Rules, Scaling Protein Purification, And More.

The FDA changed expectations for nitrosamine drug substance-related impurities reporting, accepting progress reports in lieu of full compliance. Here's what it means.

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.

The company is speeding up process optimization with tools like predictive analytics, digital twins, and generative AI copilots.

Discover the essentials of scaling protein purification and tackling challenges like purity, cost-efficiency, and scalability. Gain practical strategies and solutions to achieve reproducible, scalable results.

The monoclonal antibody intermediate is engineered for precise delivery of the linker-payload complex. Discover how rigorous storage measures ensure its quality, which is crucial for successful conjugation and functionality.

How can biopharma reduce its environmental footprint? Discover a refurbishment model that transforms single-use components into a multi-use system, significantly cutting down on disposable plastic waste.