Services

Capitalizing on our established platform for manufacturing cGMP-compliant, clinical-grade ancillary products, Akron is well positioned to provide custom development and manufacturing to enable the advancement of cell therapies. With end-to-end services from early stage process development to aseptic fill and finish, we ensure product continuity and rigorous quality control for both clinical and commercial applications. Many of our products are embedded in late-stage clinical trials and FDA approved cell therapies, substantiating our commitment to regulatory adherence and security of supply.

Akron’s Services

The unique team at Akron has amassed decades of experience in process development, scale up, formulation, and CMC document preparation through work in biologics, human derived products, technology implementation, and media innovation. Our broad expertise and vision are highly sought after, particularly for challenging projects which demand carefully considered approaches. While many of these skills are shared by other providers in the market, the potent combination of knowledge and real world experience in bringing products to market ensures achievement of the desired milestones for your company. Our expertise secures your success.

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
  • Multiple Platforms – Varied expression systems (E. coli, CHO, Pichia, and others) available depending on suitability to desired protein, cytokine or monoclonal antibody
  • Robust Quality Systems – ISO 13485 certified site with ISO 7 and ISO 5 suites and PIC Scheme compliant cGMP pharma grade production site
  • Large Scale Capacity – Gram-scale production to ensure consistency and security of supply
  • Small Batch Feasibility – Early stage media (10+L), clinical trial material and bio-scaffold development and manufacturing to grow with your needs
  • In-House Quality Control – Biological release testing and animal facilities available for safety and in-vivo bioassays
  • Superior Sterility – Sterile filtration and lyophilization in-house to support integrity of the final product
  • Animal Origin Free – Validated processes optimized to remove animal components and enable worldwide regulatory compliance
  • Project Management – Dedicated team member to guide projects to success
  • Comprehensive Consulting – Available upon request from development through to commercial