InVitria Launches Optibumin® 25: A Groundbreaking 25% Recombinant Human Serum Albumin Designed for Closed-System Biomanufacturing
InVitria, a recognized innovator in the development of recombinant, chemically defined components for biomanufacturing, has announced the commercial launch of Optibumin® 25 — a first-of-its-kind solution that addresses longstanding industry challenges in cell and gene therapy production. This product is the world’s first recombinant human serum albumin (rHSA) available in a 25% concentration, specifically engineered to support closed-system biomanufacturing workflows. With its introduction, InVitria aims to replace plasma-derived human serum albumin in sensitive manufacturing processes with a safer, more consistent, and scalable alternative.
Human serum albumin is a critical excipient and stabilizer used in a wide range of biopharmaceutical applications, including vaccine production, cell therapy, gene therapy, and regenerative medicine. However, for decades, the industry has relied heavily on plasma-derived HSA, which presents multiple challenges, particularly in the context of large-scale, clinical-grade manufacturing. Plasma-derived albumin carries inherent risks of batch-to-batch variability, supply chain constraints, pathogen transmission, and regulatory scrutiny due to its human blood origin.
With Optibumin® 25, InVitria is providing a chemically defined, animal-origin-free, and GMP-compliant recombinant albumin solution that not only meets but exceeds the performance expectations set by its plasma-derived counterpart. The product is immediately available in a convenient 100 mL, single-use bag format, facilitating easy integration into existing bioprocesses.
“Optibumin 25 directly replaces plasma-derived 25% HSA while enhancing process control and reducing regulatory risk,” said Scott Deeter, CEO of InVitria. “It enables the kind of consistency required for clinical and commercial-scale production.”
Addressing Critical Challenges in Biomanufacturing
Biomanufacturing processes — particularly those related to advanced therapies like viral vector development, stem cell expansion, and personalized gene therapies — require precise, consistent, and contamination-free raw materials. The use of human blood-derived materials such as plasma-derived HSA introduces unpredictable variability and contamination risks that can affect product quality and patient safety.
Optibumin® 25 was developed to directly tackle these pain points:
- Eliminating Pathogen Risks: Unlike plasma-derived albumin, which can carry viruses or other human pathogens, Optibumin 25 is manufactured using a recombinant process that eliminates the possibility of human-borne contaminants.
- Reducing Regulatory Burden: Regulatory authorities across the globe have increased scrutiny on animal- and human-derived components due to their potential risk to product purity and patient safety. Optibumin 25 is animal-origin-free, thus minimizing regulatory hurdles and streamlining approval pathways.
- Ensuring Supply Chain Reliability: The global supply of plasma-derived albumin is limited by donor availability and geographic distribution. By contrast, recombinant manufacturing offers a scalable and more sustainable production method.
- Improving Consistency: Batch-to-batch variability with plasma-derived albumin can cause fluctuations in performance and formulation behavior. Recombinant Optibumin 25 delivers tightly controlled purity and consistency, crucial for reproducibility in commercial production.
Designed for Closed-System Manufacturing
One of the key innovations of Optibumin 25 is its suitability for closed-system processing, an essential feature for modern biomanufacturing environments. Closed systems reduce the risk of contamination during production and are increasingly preferred — or even required — for high-grade biologics manufacturing.
By offering a 25% concentration of rHSA in a ready-to-use sterile bag, Optibumin 25 aligns with the needs of closed, aseptic workflows used in:
- Viral vector production for gene therapies
- Stem cell preservation for regenerative medicine applications
- Cryopreservation protocols to protect cells and biologics during storage
- Vaccine formulation, including mRNA-based technologies
- Final formulation and fill-finish processes
This format simplifies implementation into existing systems while enhancing operational safety, sterility, and reliability.
Manufactured Under Rigorous Quality Standards
InVitria produces Optibumin 25 in its ISO 9001-certified and current Good Manufacturing Practice (cGMP)-compliant facility, ensuring that every lot meets the highest standards for biopharmaceutical use. The facility is designed to accommodate clinical and commercial-scale production, offering customers a seamless path from early-stage development through to market-ready manufacturing.
Key features of Optibumin 25’s manufacturing profile include:
- Chemically defined formulation — no animal or human-derived components
- Sterile and stable at 25% concentration, eliminating the need for on-site dilution or additional sterilization steps
- Low endotoxin and bioburden levels, suitable for sensitive downstream applications
- Validated fill-and-finish in sterile bags for closed processing environments
By controlling every step of production — from recombinant protein expression to purification and packaging — InVitria ensures that Optibumin 25 offers unparalleled quality, safety, and reproducibility.
Meeting the Evolving Demands of Cell and Gene Therapy
The demand for recombinant human serum albumin has grown significantly as the biopharmaceutical industry shifts toward next-generation therapies. Applications such as CAR-T cell therapy, AAV-based gene delivery, and autologous stem cell treatments require tightly controlled environments where even minor impurities or inconsistencies can compromise clinical outcomes.
Optibumin 25 not only meets these demands but also helps therapy developers and manufacturers:
- Streamline process validation
- Accelerate regulatory submission
- Avoid raw material shortages
- Minimize deviations in critical quality attributes (CQAs)
Its chemically defined nature also aligns with the Quality by Design (QbD) principles increasingly adopted by biopharma companies and regulators alike.
Summary of Key Advantages
Optibumin® 25 represents a major leap forward in the quality and safety of raw materials for biomanufacturing. Its unique value proposition includes:
- ✅ First recombinant 25% human serum albumin designed for closed bioprocessing systems
- ✅ Animal-origin-free and chemically defined, mitigating contamination risks
- ✅ Manufactured under cGMP conditions, ensuring regulatory compliance
- ✅ Stable, sterile, and ready-to-use, reducing operational complexity
- ✅ Scalable production for clinical and commercial volumes
- ✅ Compatible with a wide range of applications, including viral vectors, vaccines, stem cells, and cryopreservation
The introduction of Optibumin 25 underscores InVitria’s commitment to driving innovation in biologics manufacturing. As regulatory expectations tighten and the industry moves toward fully defined, closed-system processes, recombinant solutions like Optibumin 25 will become not just preferred, but essential.
With this launch, InVitria empowers biopharmaceutical companies to transition away from legacy materials and adopt a next-generation standard in raw material safety, consistency, and regulatory readiness — setting a new benchmark for excellence in cell and gene therapy production.
