09.26.25 -- The Building Blocks Of A Robust Analytical Assay

The heterogeneity of a biologic product has implications for the final therapy's safety and efficacy. Explore challenges associated with charged variants, including mAbs and fusion proteins.

Companies still relying on paper-based manufacturing are falling behind. Examine how digital transformation boosts efficiency and reduces errors in this essential shift toward smarter operations.

Discover how spatial profiling and advanced imaging tools are transforming drug discovery, featuring Wayne Stallaert’s lab’s work on cell cycle mapping and biomarker insights in cancer research.

Learn how a biopharma leader modernized its equipment changeover process using an innovative platform to achieve faster execution, fewer errors, and greater visibility through digitized SOPs.

Explore how light scattering reveals the structural integrity, aggregation, and stability of GLP-1 analogs to advance drug formulation and enhance treatment efficacy for type 2 diabetes and obesity.

Single-use technologies (SUTs) bring speed and flexibility to biomanufacturing, but realizing their full value requires stage-specific risk management to navigate material, supply chain, and other challenges.

We developed and validated a dual screening procedure (genotype and phenotype) for Lonza human peripheral blood mononuclear cells (PBMCs) to identify donors with high ADCC potential.

Learn about smart manufacturing and how connected, electronic batch records enable smarter and more efficient manufacturing capable of addressing current and future production challenges.

Here, Abigail Kelliher, Associate Marketing Director for Clinical Solutions and Companion Diagnostics at BD, answers questions about flow cytometry and the advantages of taking a standardized approach.

Explore process characterization services based on QbD principles, with an emphasis on risk and knowledge management and transforming data into the currency of product and process knowledge.

To meet immediate vaccine demand, aseptic manufacturing capacity must increase quickly. This means environmental monitoring programs must adapt rapidly as well. Thoughtful planning can help.

In vitro transcribed mRNA transforms biotherapeutics, which necessitates thorough quality assessments. See how an analyzer system enhances encapsulation efficiency and CQAs in IVT mRNA workflows.

If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

A team of Duke University researchers sought to explore the viral infection process before the virus has bonded to tissue, understanding how viruses navigate the epithelial space, through mucus and the periciliary layer.

Discover how intelligent automation is revolutionizing CQV in life sciences to eliminate manual bottlenecks, accelerate timelines, and enhance compliance in an era of increasing regulatory scrutiny.

Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.