Interview: How recombinant albumin can help de-risk cell therapy manufacturing

Tom: Evonik is distributing our recombinant human albumin portfolio globally under the CreaCyte® brand. The portfolio includes four products: Cellastim® S, Exbumin®, Optibumin® 20, and Optibumin® 25. At InVitria, we bring deep experience in albumin applications, regulatory engagement, and product development. Combined with Evonik’s global reach, this allows us to support customers from early development through to commercialization.

Sabrina: By distributing InVitria’s recombinant albumin products under Evonik’s CreaCyte® brand, we can bring these solutions to a broader customer base. They also complement Evonik’s cell culture ingredients portfolio for the biopharma market. By combining InVitria’s product expertise with Evonik’s global footprint, customer relationships, formulation expertise, and complementary excipient portfolio, we can offer customers a wider range of solutions.

Jake: Albumin derived from human plasma comes with built-in constraints. It depends on human blood donations, which are impossible to scale. Plasma is also inherently variable because it is often pooled from multiple donors. This increases the need for testing, traceability, and documentation, while also creating potential contamination risks.

Chemically defined recombinant albumin helps address these challenges. It is produced using recombinant DNA technology in non-animal expression systems, enabling greater consistency, safety, and process control. We often work with customers developing next-generation therapies who still rely on human blood donation for critical raw materials. When chemically defined alternatives are available, that is an unnecessary risk.

Sabrina: Evonik and InVitria share a clear ambition: to provide the market with high-purity, non-animal excipients, and ingredients. By bringing together our capabilities, we can make rHSA globally accessible while supporting a secure supply chain for customers.

Jake: Evonik is a global organization with strong relationships across the biopharma industry. Introducing a next-generation product such as recombinant albumin into those existing conversations is a natural extension. A material that does not depend on plasma collection, can be produced at predictable scale, and is backed by an established supplier is a powerful combination.

Sabrina: Supply security is a major benefit. As programs move toward commercial scale, customers need confidence that critical materials will be available reliably. Plasma-derived products are finite and vulnerable to supply disruption. With InVitria’s recombinant albumin supported by Evonik’s global infrastructure, customers can plan for a commercial supply chain even while they are still working at bench scale.

Jake: Optibumin® 25 is the first recombinant human serum albumin available as a 25% liquid solution. That concentration matters because it matches blood-derived clinical HSA, making it a true replacement in both format and concentration. From a purity perspective, Optibumin® 25 is more consistent and significantly purer than blood-derived alternatives. It also carries the same credentials as the rest of the InVitria portfolio: no stabilizers at any point in the process and completely animal-origin-free.

Optibumin® 25 is also built on the same rice-derived recombinant platform with excipient approval from the FDA and EMA. This regulatory familiarity has allowed us to collaborate with customers on final formulations in vaccine and advanced therapy manufacturing.

Sabrina: The 25% rHSA solution is a strong addition to the market, and I am excited that Evonik is among the first companies to integrate it into our distribution portfolio.

Jake: We designed this system after working closely with cell therapy developers and listening to customer needs. Cell therapy manufacturing processes, including T cells, NK cells, and MSCs, are increasingly run in closed systems. In these processes, sterility is paramount. Every time a container is opened or a powder is reconstituted in a clean room, risk is introduced.

Our 100 mL bag includes sterile connection ports and thermal weldable tubing for direct integration into closed Good Manufacturing Practice (GMP) systems. This is essential if we want to provide cell therapy reagents that support GMP programs. The goal is to give customers a product that connects directly to their existing process, and currently there is no other recombinant option in this bag size.

Sabrina: The closed bag system fits customer needs very well. Cell therapy processes typically require smaller volumes, unlike larger-scale cell culture applications such as antibody production.

Sabrina: The cell and gene therapy market is growing rapidly, but scale-up and commercialization remain major hurdles. Reliable, high-quality components will be critical to making these therapies more accessible. Our partnership helps address this by enabling more consistent manufacturing and stronger supply security.

Jake: As therapies scale, raw materials can become a bottleneck. This is especially true for plasma-derived components, which are not suited for industrial production and rely completely on blood donations. Recombinant, chemically defined materials such as rHSA offer the consistency and scalability needed for commercial success and are increasingly being adopted across the industry.