Akron develops and manufactures custom media that support the culture and expansion of cell therapy products. Our team can engage in the initial stages of defining and developing a new formulation or even help to optimize an existing recipe for improved performance. Beginning with small scale (10+L) productions, we can support your cGMP progress through process development, validation of specifications and stability programs to a compliant final product. Regardless of the stage, Akron works as a flexible partner to accommodate the budget, scale and timelines unique to each project.
cGMP Media Optimization and Development
Akron specializes in optimizing media for more efficient cell production, from transferring a well-defined formulation to investigating an unknown or poorly defined recipe. We can manufacture multiple small-scale batches (10+ L) with different compositions for testing and nimbly revise the recipe based on results to best meet your needs. With decades of experience developing media through problem-solving and troubleshooting, we have deep expertise in fine-tuning existing media formulations and can offer guidance in defining and designing new, proprietary formulations. For all projects, the final formulation recipe and process are always the property of our clients, further mitigating the risk of supply while enhancing both flexibility and affordability.
At Akron, we focus on small-batch, custom cGMP media to improve quality and free up your internal resources. By enabling manufacturing from 10L to 500L, we make it possible to outsource media production earlier in the process at a scale that is optimized for cell therapies and smaller clinical trials. We can bring a benchtop media up to cGMP standards through supplier, process and specification validations, bioassay development where necessary, management of stability campaigns and scale up for commercialization. The SOPs, batch records and testing results from development and engineering runs form a comprehensive cGMP documentation package to establish a quality process and product. Our wide array of packaging options and flexibility allows for custom solutions that offer improved connectivity and limit required user manipulation.
- Small Batch Feasibility – Early stage media production (10+L) can be aliquoted for single-use and grow with your needs to 500L
- Affordable Direct Sourcing – Internal access to cGMP ancillary materials for improved quality control and efficiency
- Various Container Options – Multiple formats from bottles to custom bags for your application
- External Supplier Qualification – Raw material agnostic sourcing allows for flexibility in your supply chain and alleviate your workload
- Comprehensive Documentation – Development of process, testing, and release package in line with cGMP requirements