Author: Alexia Armstrong

Why Do Some Biologics Cross the Finish Line—While Others Crash and Burn?

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Reading time: 4 minutes Share this article:   Imagine spending years and millions developing a groundbreaking biologic, only to see everything fall apart right at the doorstep of FDA approval. Frustrating, right? Unfortunately, it’s common—and often boils down to one overlooked area: Chemistry, Manufacturing, and Controls (CMC). So why exactly do promising biologics get derailed …

InVitria Launches Optibumin 25 rHSA

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InVitria® Introduces Optibumin® 25: The First 25% Animal-Free Recombinant Human Serum Albumin for Cell & Gene Therapy Manufacturing Junction City, KS – February 20, 2025 – InVitria, a leading provider of recombinant, chemically defined  biomanufacturing and formulation components, today announced the launch of Optibumin 25, the first and only recombinant human serum albumin (rHSA) available …

Cryopreservation Just Got Better with Optibumin® 25

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Reading time: 6 minutes Share this article:   Optimizing Cryopreservation with Animal-Origin-Free HSA Solutions Struggling with cell viability after thawing? You’re not alone. Cryopreservation plays a crucial role in biomanufacturing, especially in developing cell-based therapies, where post-thaw viability can impact everything from functionality to clinical success. Traditionally, dimethyl sulfoxide (DMSO) has been the go-to cryoprotectant, …

Retain and Protect Final Cell Product with Optibumin®, a Recombinant Human Serum Albumin (rHSA)

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Key Points Optibumin®, InVitria’s high-purity recombinant human albumin, improves viable T cell retention during downstream washing. Optibumin performs comparably to clinical serum-derived HSA in this application, enabling a like-kind replacement. Optibumin is animal origin free, offering safety and regulatory advantages. Introduction Critical Role of Albumin in Cell Washing for Cell Therapy Cell washing occurs at …

How Regulatory Bodies Are Driving the Shift to Animal-Origin-Free Solutions in Cell Therapy and Vaccine Development

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Reading time: 6 minutes Share this article:   Global regulatory agencies—including the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), WHO (World Health Organization), and PMDA (Pharmaceuticals and Medical Devices Agency of Japan)—are driving the shift to animal-origin-free (AOF) solutions in cell therapy and vaccine manufacturing. Their goal: to enhance product safety, standardize …

Enhanced Cryopreservation of T Cells Using Optibumin®, Recombinant Human Serum Albumin (rHSA)

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Key Points Optibumin® Improves T Cell Recovery and Proliferation Post-Thaw Optibumin significantly enhances T cell viability and proliferation post-thaw compared to human blood-derived clinical HSA. Reduction of DMSO Concentrations in CryoStor® Formulations The inclusion of Optibumin solution physically displaces an equal volume of CryoStor to enable a reduction in final DMSO concentrations, improving the safety …