Newsletter | July 28, 2022

07.28.22 -- The Need For Creative Funding For Life Sciences

New Podcast Episode
Featured Editorial
Industry Insights
Similar Enough Product Characterization To Support Process Changes And Biosimilar Development

Small differences in manufacturing conditions can have dramatic effects on a product’s structure and biological activity. Characterization is essential to understand the impact following process changes and successful biosimilar development. We will provide best approaches for comparability studies.

Manufacturing Of Sterile Aqueous Suspensions: A Primer

Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing. 

Tackling Supply Chain Challenges With Multisite Manufacturing

Gain a more thorough understanding of single-use technology, security of supply, business continuity management, and the need to take action to benefit from multi-site manufacturing.

Control Strategy Factors For Drug-Device Combination Products

Building a control strategy comprises understanding the connectivity among materials of composition, components, constituent parts, the final drug-device combination product, and critical process parameters.

Sensitive And Reproducible SPR-Based Concentration And Ligand-Binding Analyses

Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and ongoing quality control. This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.

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