BOCA RATON, Fla.--(BUSINESS WIRE)--Akron BioProducts, a leading supplier of cGMP-compliant materials and technologies for cell and gene therapy manufacturing, today announced the launch of its Closed System Solutions™ (CSS) product line, aimed at functionally closing critical unit operations in cell and gene therapy manufacturing workflows. Akron’s industry-leading liquid Recombinant Human Interleukin-2 (rHu IL-2), Human AB Serum Converted from Octaplas®, and Human Serum Albumin 25% Solution are now available in single-use, ready-to-use bags with weldable tubing.
Cell and gene therapy developers have long sought to streamline the integration of critical liquid-format cGMP materials into their manufacturing processes. Driven by industry demand for a robust ancillary material delivery platform that provides consistency and sterility assurance, Akron has engineered its CSS product line to integrate optimally dosed, cGMP-compliant human plasma-derived media supplements and liquid cytokines across manufacturing platforms.
Akron’s CSS line includes:
- Human Interleukin-2 (1 MIU, 15 MIU)—biosimilar to Proleukin®, available in a ready-to-use, liquid formulation
- Human AB Serum Converted from Octaplas® (60 mL, 100 mL)—leveraging virus inactivated, S/D treated, pooled human plasma to maximize patient safety and batch-to-batch consistency
- Human Serum Albumin 25% Solution (60 mL, 100 mL)—formulation and fill volumes optimized for use across cell therapy manufacturing platforms
Akron’s CSS products leverage existing cGMP manufacturing processes and have Drug Master Files with FDA for seamless regulatory support. They are available in several volumes and concentrations with multiple connection options, enabling preclinical to commercial cell and gene therapy manufacturing.
Additional cGMP cytokines including IL-7, IL-15, and IL-21 will be available in CSS format later this year.
“The broad-based adoption of these novel therapeutic modalities will depend on our ability to industrialize the manufacturing workflow, standardizing critical inputs and establishing modular system architectures to ensure safety and consistency at scale,” noted Ezequiel Zylberberg, Vice President of Product Development and Planning at Akron BioProducts. “The introduction of our Closed System Solutions line allows for the streamlined delivery of cGMP ancillary materials into the manufacturing process. We view this as a vital step on the path towards a scalable production system that will allow us to deliver on the promise of these novel treatments.”
More details about Akron’s new Closed System Solution products can be found on www.akronbiotech.com.
Akron BioProducts is a leading materials manufacturer and services provider to the cell and gene therapy industry. An ISO 13485-certified company operating in line with cGMP guidelines and international standards, Akron leverages more than 100,000 square feet of development and manufacturing capacity to provide advanced therapy developers the scale, compliance, and regulatory support necessary to drive novel treatments from discovery to commercialization. For more information, please visit www.akronbiotech.com.
Trademarks are property of their respective owners.