Akron provides custom fill & finish services, filling single-use, closed packaging and custom kit options for customers in the cell and gene therapy industry. We offer smart solutions that allow for more streamlined, consistent manufacturing with little to no manipulation, 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.
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. Contact us today to discuss your fill & finish needs.
- Identify, qualify, and source materials, performing a risk assessment, and finding primary and secondary sources for critical components
- Transfer technology of any prior work completed on formulation or manufacturing processes
- Complete aseptic media fill in ISO 7 cleanroom and ISO 5 LFH subject to full environmental monitoring, including development runs and engineering/validation runs to validate your sterile-fill claim
- Set specifications for the manufacturing process and final product based on consistent and repeatable data (if not already set)
- Formulate & fill in custom, single-use, and closed syringes, bottles and bags with semi-automated dispensing and crimping capabilities
- Final product labeling, inspection, and packaging to support seamless supply chain integration
- Set-up stability studies (accelerated or concurrent) to validate sterility claims in new packaging