Akron offers development and manufacturing services to produce proteins suitable for culturing cellular therapeutics or for use as a final protein-based therapeutic product. We offer end-to-end in-house services from cloning and expression to fill and finish — translating benchtop research materials to industrial quality products while developing the process, acceptance criteria, and documentation.

cGMP Protein Development and Manufacturing

Akron specializes in developing native recombinant proteins, with deep expertise in IL-2, muteins, modifications, and variants. Cloning and expression can be optimized in a variety of bacterial and mammalian expression systems such as E. coli, P. pastoris or CHO. Native proteins can be generated without affinity tags as we have pharmaceutical manufacturing compliant capabilities to purify via SEC, TFF and other routes. We have extensive experience in PEGylation and other post translational modifications for therapeutic applications. Research, master, or working cell banks can be established which are characterized and tested for stability and batch-to-batch consistency under GLP initially and then transitioned to cGMP compliant cell banks in later phases. At Akron, our approach is to establish at small scale a strong foundational manufacturing process, through extensive investigation and optimization, which will seamlessly lead to the large scale production of a pure and functional protein.

Akron provides comprehensive manufacturing services including numerous different scale options, in-house sterile lyophilization and aseptic fill and finish to support flexibility and integrity of the final product. With years of experience developing and manufacturing recombinant proteins, we can rapidly optimize and troubleshoot processes from purification to formulation. We manufacture recombinant proteins at all scales—from laboratory, pilot, and clinical, to commercial gram-scale—to ensure consistency in supply. Our recombinant proteins are manufactured using single-use bioreactors within a pharmaceutical facility, providing the highest level of quality and degree of compliance, and custom packaging and shipping validations can be undertaken as needed. Each product includes a comprehensive analytical package with multiple types of testing and documentation to confirm protein identity, function, and purity. It is this commitment to quality which we incorporate into all our services that guarantees the most consistent and sterile cell therapy products.

IL-2, a critical cytokine in cell culture media for expansion of cells, has traditionally been supplied as a lyophilized powder. In this format it must be reconstituted before use, including for the regular additions during the manufacture of a cell therapy which could span weeks. The end user must open the vial, reconstitute with WFI, withdraw the exact amount, and add it to the culture. These steps and manipulations add labor time and run the risk of introducing errors and contaminants. Recognizing an opportunity to improve safety and customer experience, Akron developed a stable liquid formulation of IL-2 in a Luer Lock syringe, with equivalent shelf life to the lyophilized product. This novel formulation and packaging enabled reduction in the number of process steps, materials, and labor, lowering the resultant cost of goods sold (COGS). Additionally the ready-made syringe of a pre-measured solution with aseptic connectivity eliminated the risk for errors in handling and delivery, further enhancing safety and reproducibility for patients with unmet medical needs.

 

*Patent pending.

Struggling with your protein? It’s easy to begin conversations with our experts. Simply call or email to learn if our capabilities are a match for your project. Then complete a questionnaire with your process details and our team will respond with an estimate and phased proposal for your review.

Service Highlights

  • Protein Expertise – Decades of experience in custom protein engineering, process development and improvement, molecule and post-translational modification, purification, and formulation of interleukins and other families of proteins
  • Large Scale Capacity – Gram-scale production to ensure consistency and security of supply
  • Superior Sterility – Sterile filtration and lyophilization in-house to support integrity of the final product