Akron’s sterile manufacturing facility, presented here before, enables the unique preparation of products within a fully aseptic manufacturing environment, including sterile filtration and container-closure filling.
And while this allows Akron to manufacture cGMP-compliant, sterile-filled cytokines and ancillary materials for cell therapy, Akron also extends these capabilities as services to serve the industry: Owing to our unique facilities, our manufacturing capabilities are among the industry’s most advanced, and we extend these facilities to deliver complete packaged solutions to our customers.
Akron provides process optimization and manufacturing services to cell and gene therapy companies and academic organizations. We have built the most extensive set of capabilities in the industry and are focused on providing solutions to the many challenges that the cell therapy field faces.
What are some of the services? They extend from simple fill/finish operations to custom recombinant protein manufacturing, reformulations, stability studies or bioassays – and that’s not all. If an off-the-shelf product is not suitable for you – either due to the presence of specific excipients or you need to extend the shelf life – or if you are unsure about quality needs, we can provide comprehensive guidance on everything including GMP-compliant quality affairs.
Moreover, labeling, packaging, shipment and cold-chain management are all embedded within our capabilities.
Akron’s participation in standardization efforts, industry consortia and involvement with organizations such as ISO and USP gives us a unique advantage by leveraging our expertise from being involved in shaping the industry’s path forward.
The list below touches on some of our key capabilities:
- Custom recombinant product manufacturing
- Sterile fill/finish
- Cell Banking
- Custom Product Design and Formulation
- Stability studies
- Cold chain management
- Assay Development
- 3D Scaffolds development and manufacturing
- Regulatory Support
- Supplier Audit
- Project management
But some of the greatest value Akron can provide is project management and full guidance and support – our clients repeatedly highlight the unique value we have added to our workflows, by providing one-on-one, customized and fully-personalized guidance throughout each project. This level of attention and support is unparalleled in the industry, and something that Akron takes great pride in.
And all of this is readily accessible: we are always available to talk, and informal contact to enquire about how our expertise can be put to work for you is always welcome.
So please get in touch.