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

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)

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 …

Advancing Vaccine Excellence

InVitria is transforming vaccine production with safer, scalable, and sustainable solutions. This infographic showcases how our recombinant, animal-free technologies address key challenges in traditional vaccine manufacturing, such as contamination risks, inconsistent supply, and cold chain logistics. Key highlights include: Safer Solutions: Eliminate risks from animal- and human-derived components, ensuring vaccine quality and patient safety. Scalable …

Innovative Solutions in Closed-System Biomanufacturing: Exploring the Tools and Technologies Driving Sterility and Efficiency

Reading time: 4 minutes Share this article:   As biomanufacturers strive to meet the growing demand for high-purity therapeutics, closed-system biomanufacturing has emerged as a cornerstone for success. In our previous post, we explored the evolving challenges in implementing closed systems, from maintaining sterility to navigating regulatory requirements. Now, we turn our focus to the …

Evolving Challenges in Closed-System Biomanufacturing

Reading time: 5 minutes Share this article:     Closed-system biomanufacturing has revolutionized cell and gene therapy production, offering unparalleled sterility and control. However, as the industry advances and regulatory expectations for contamination control increase, new challenges arise that demand innovative solutions. In this blog post, we’ll explore the evolving complexities of closed systems and …

T Cell Cryopreservation Using Exbumin®, Recombinant Human Serum Albumin, and Reduced DMSO

Key Points Exbumin®, recombinant human serum albumin (rHSA), demonstrated superior T cell viability, health, and proliferation post-cryopreservation compared to clinical HSA and a 10% DMSO solution. Notably, this was achieved with only 2.5% DMSO, demonstrating Exbumin’s ability to reduce DMSO concentrations without compromising cell health. Exbumin is an approved excipient for therapeutic injection and offers …

Scaling Innovation: How DiscGenics and InVitria are Leading the Future of Cell Therapy

Reading time: 5 minutes Share this article:       The cell therapy industry stands on the edge of a transformative era. With advancements in treatment options and scalable manufacturing processes, companies like DiscGenics™ are leading the charge, delivering innovative therapies for previously intractable conditions. Simultaneously, market dynamics are shifting, with renewed investor confidence signaling …

Maintaining Viable Cell Count in Primary T Cells During Cell Washing Using Optibumin®

Key Points Optibumin®, InVitria’s high-purity recombinant human albumin, performs comparably to serum-derived albumin in cell wash experiments, retaining nearly all cells and maintaining excellent viability after washing. Optibumin offers the additional benefits of animal-free origin and consistent quality. Introduction Downstream cell washing is a critical step in cell therapy manufacturing processes (Figure 1). During this …