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

EXECUTIVE SUMMARY Human serum albumin (HSA) is exemplary among proteins in drug complexation applications. It is capable of binding a wide variety of ligands with high affinity, is resistant to renal filtration, has a lengthy in vivo half-life, is incredibly soluble, and contains multiple drug binding sites. These unique pharmacological properties of albumin are due …

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

EXECUTIVE SUMMARY Covalent conjugation of drugs and diagnostic imaging reagents to albumin is a versatile and widely used strategy in pharmacology. This chemistry improves drug stability in serum, reduces renal clearance, and increases solubility, while also being highly specific. Conjugation is usually accomplished by reacting a pharmacological agent with the free thiol form of albumin’s …