Supply Chain Resilience: The Fragility and Finite Nature of Serum-Derived Raw Materials

Reading time: 7 minutes Share this article: The biopharmaceutical supply chain is currently resting on a fragile foundation of animal- and human-derived raw materials. As the number of approved biologics and advanced therapies continues to grow, demand for serum-derived components is increasing against a finite and increasingly constrained supply base. This article examines four primary …

Safety and Contamination Risks: The Testing Burden and Persistent Threats

Reading time: 3 minutes Share this article: Biomanufacturing safety is currently compromised by the persistent risk of adventitious agents inherent to serum-derived products. Fetal bovine serum (FBS) is frequently contaminated with bovine viral diarrhea virus (BVDV), a virus that can evade standard filtration and survive irradiation. Human AB serum presents a different but equally significant …

Recombinant Albumin as a Carrier Protein Improves Cytokine Recovery and Functional Stability at Dilute Concentrations

Audio Summary: Optibumin 25 Stabilizes High-Cost Cytokines Overview This application note evaluates the use of Optibumin® 25, a recombinant, animal-origin-free human serum albumin (rHSA), as a carrier protein to stabilize dilute cytokine formulations commonly used in cell culture and cell therapy workflows.The study demonstrates that Optibumin 25 significantly improves cytokine recovery by reducing losses due …

Variability and Failed Lots: The Hidden Quality Control Challenge of Serum & Serum-Derived Products

Reading time: 4 minutes Share this article:   The biopharmaceutical industry faces a critical quality control challenge: the inherent variability of serum and plasma-derived products. While traditionally relied upon for cell culture, blood-derived albumin introduces significant lot-to-lot inconsistencies in protein heterogeneity, growth factor content, and biochemical profiles. These variations directly impact manufacturing success, particularly in …

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 …