Consistency Is the New Compliance

How tightening regulations and new data are reshaping expectations for material consistency and traceability. Ask anyone in advanced therapy manufacturing “What keeps you up at night?”…the answer is usually the same; variability. Every batch tells a story, some of success, some of struggle. Manufacturers work hard to control what they can, the process itself. Yet …

Why Cell Quality Erodes During Downstream Processing — and How to Prevent It | Webinar

Webinar Details Title: Why Cell Quality Erodes During Downstream Processing — and How to Prevent It Date & Time: ON DEMAND Host: GEN (Genetic Engineering & Biotechnology News) Sponsored by: InVitria What You’ll Learn Key factors contributing to cell quality loss during purification, washing, and formulation steps How raw material selection impacts viability, phenotype, and …

A Binding Advantage: Optibumin 25 Demonstrates Enhanced Drug Binding and Consistency over Plasma Albumin

Overview  Human serum albumin (HSA) plays a vital role in drug complexation and delivery. However, plasma-derived HSA is heterogeneous due to donor variation, stabilizers, and aggregates that can interfere with drug binding. These inconsistencies can affect pharmacokinetics, reduce formulation predictability, and complicate regulatory alignment. In this application note, InVitria compares Optibumin® 25, an animal-origin-free recombinant …

Thiol by Combat: Enhanced Covalent Conjugation with Recombinant Albumin Compared to Human Plasma-Derived Albumin

Overview  Covalent conjugation of drugs and diagnostic reagents to albumin is a widely used strategy in drug development. This approach improves solubility, stability, and pharmacokinetics while offering high specificity through the free thiol group at cysteine-34 (Cys34). However, plasma-derived human serum albumin (HSA) is a deficient and inconsistent conjugation partner — up to 40% of …