Services

Efficient recombinant protein production

Akron Biotech has extensive experience in the cGMP production and purification of recombinant proteins to support the cell, gene, and tissue therapy industries. We have particular expertise in the manufacture of monoclonal antibodies, cytokines, and growth factors. Our talented scientific, quality, and regulatory staff support our clients to accelerate their path to market. Contact us today to discuss your protein production needs.

Our Contract Development and Manufacturing Services and Capabilities:

• Cell Line Development
• Process, Analytical, Formulation, and Packaging Development
• Clinical & Commercial Manufacturing

Aseptic fill & finish services

Akron Biotech provides custom fill & finish into single-use, closed packaging and custom kit options to the cell and gene therapy industry. We offer smart solutions to allow for more streamlined, consistent manufacturing with little to no manipulation all while reducing waste and costs of goods. Our single-use packaging ranges from bottles, vials, pre-filled syringes, and bags in a variety of sizes with options for closed connections/tubing. Contact us today to discuss your upcoming fill & finish needs.

Our Fill & Finish Services and Capabilities:

• Identify critical components, perform a risk assessment, and find primary and secondary sources for critical components.
• Qualify and source raw materials from client’s approved suppliers/Akron approved suppliers.
• Transfer technology of any prior work completed on formulation or manufacturing processes.
• Complete aseptic media fill, development runs, and engineering/validation run to validate your sterile-fill claim.
• Set manufacturing process/specifications and final product specifications based on consistent and repeatable data (if not already set).
• Formulate & fill in custom, single-use, and closed packaging.
• Set-up accelerated or concurrent stability studies to validate sterility claims in new packaging.

Our customers range from academic universities and research institutions to early stage biotech startups to global pharmaceutical companies. Let Akron be your trusted partner in bringing your product to market.