Author: Alexia Armstrong

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

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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

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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

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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

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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

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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 …

Improved iPSC Cryopreservation with Optibumin 25: Enhanced Viability, Expansion, and Pluripotency

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Audio Summary: Improved iPSC Cryopreservation with Optibumin 25 Overview This application note evaluates the performance of Optibumin® 25, a recombinant, animal-origin-free human serum albumin (rHSA), in the cryopreservation of human induced pluripotent stem cells (iPSCs). The study demonstrates that Optibumin 25 enables a significant reduction in DMSO concentration while improving post-thaw viability, expansion, and pluripotency. …

Superior Cryopreservation of T Cells in Low-DMSO, Animal-Origin-Free Formulation Using Optibumin 25 and PentaHibe Base

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Overview This application note presents a defined, animal-origin-free (AOF) cryopreservation strategy addressing the limitations of high-DMSO and serum-derived components. The formulation—10% PentaHibe Base, 2% DMSO, and 4% Optibumin 25—was tested in CAR-T–mimicking workflows using healthy donor T cells. PentaHibe Base is a non-penetrating, carbohydrate-based cryoprotectant derived from pentaisomaltose, a patented subfraction of Dextran 1 with …

Optibumin 20 – Guidelines for Use

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Download the Optibumin 20 Guidelines for Use to learn preparation, concentrations, storage, and applications of recombinant HSA. High free‑thiol Cys‑34 content and 99% fatty‑acid‑free profile support small‑molecule solubilization, bioconjugation, and sensitive applications including iPSC, hESC, and IVF.