Author: Alexia Armstrong

Recombinant Albumin Preserves Dilute Cytokine Recovery and Bioactivity at Room Temperature

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Dilute cytokines lose activity during routine handling because of surface adsorption, aggregation, and oxidative degradation — losses that introduce variability into cell therapy and biomanufacturing workflows. In a 4-week stability study across refrigerated (2–8°C), room-temperature, and elevated (35–40°C) conditions, InVitria® evaluated whether Optibumin® 25, a recombinant human serum albumin (rHSA) produced in a non-mammalian expression …

Certificate of Origin and Animal-Free / TSE-BSE Statement

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What This Document Covers This statement consolidates three related regulatory attestations into a single document signed by InVitria’s Director of Quality: Certificate of Origin — formally identifying the country and city where InVitria’s products are manufactured Animal-Free Component Statement — attesting that raw materials, production hosts, processing equipment, and product-contact packaging contain no animal components …

cGMP Statement

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What This Statement Documents InVitria’s cGMP Statement is a signed attestation from the company’s VP of Quality confirming that manufacturing operations, documentation practices, batch production records, equipment qualification, and process and cleaning validation are designed and operated with consideration to current Good Manufacturing Practice (cGMP) guidelines. The statement references 21 CFR Parts 210 and 211 …

ISO 9001:2015 Certificate of Registration

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What This Certificate Documents InVitria holds ISO 9001:2015 certification from Orion Registrar, Inc., an ANAB- and IAF-accredited certification body. The certification covers the full scope of InVitria’s manufacturing operations at its facility in Junction City, Kansas, and applies to all recombinant proteins produced on the ExpressTec rice-grain expression platform — including Exbumin, Optibumin 20, Optibumin …

How Merck Used Recombinant Albumin in ERVEBO to Establish a Novel Excipient Pathway

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Merck’s ERVEBO program became the first known case in which rice-derived recombinant human serum albumin (rd-rHSA) was approved as a novel excipient in a human injectable vaccine. The challenge was not whether albumin itself was known, but whether this specific recombinant material, used at this route, concentration, and formulation context, had been previously “sponsored” and …

Rapid Quantitation of SARS-CoV-2 Antibodies Using an Electrochemical Sensor

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This study shows how recombinant human albumin supports assay performance in electrochemical biosensor systems. Publication Details Publication Title: Rapid quantitation of SARS-CoV-2 antibodies in clinical samples with an electrochemical sensorJournal: Biosensors and BioelectronicsYear: 2023Article Type: Peer-reviewed researchDOI: 10.1016/j.bios.2022.115037 Study Overview This study describes the development of a multiplexed electrochemical biosensor for rapid detection of SARS-CoV-2 …

Defined Media Optimization for hiPSC-Derived Cardiomyocyte Maturation

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This study shows transferrin is a component that directly impacts cell performance. Publication Details Publication Title: Independent compartmentalization of functional, metabolic, and transcriptional maturation of hiPSC-derived cardiomyocytesJournal: Cell ReportsYear: 2024Article Type: Peer-reviewed researchDOI: 10.1016/j.celrep.2024.114160 Study Overview This study used high-throughput assays to evaluate how individual media components affect viability and maturation of hiPSC-derived cardiomyocytes. The …

Preserving Lentiviral Titer During Sterile Filtration Using Recombinant Albumin

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EXECUTIVE SUMMARY Lentivirus production is central to CAR-T manufacturing, and is even more critical with the emergence of in vivo CAR-T approaches. This puts increased emphasis on the need for high-yield lentivirus manufacturing. However, lentiviruses are inherently fragile, and infectious titer is lost at every step in manufacturing.  The shift towards suspension systems, and chemically …

Beyond Synthetic Surfactants: The Case for Recombinant Human Serum Albumin (rHSA) as an Ideal Alternative to Poloxamer 188

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Reading time: 4 minutes Share this article: For decades, the biopharmaceutical industry has relied on Pluronic F68 (Poloxamer 188, P188) as the standard shear protectant in sparged bioreactors. This reliance emerged from regulatory pressure to remove serum-derived contaminants, including BSE and TSE from manufacturing workflows. More recently, however, manufacturing disruptions linked to poloxamer 188, have …

InVitria and Cellevate Partner on Vaccine Manufacturing

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InVitria has entered a strategic collaboration with Cellevate AB to explore improved upstream solutions for viral vaccine production. The collaboration brings together Cellevate’s Cellevat3d® nanofiber microcarrier platform with InVitria’s chemically defined recombinant proteins to support scalable, animal-origin-free vaccine manufacturing workflows. Cellevat3d enables high-density adherent cell culture, while InVitria’s recombinant media components help provide consistent and …