We know every decision made in cGMP manufacturing affects the end patient. This is why we employ robust pharmaceutical grade purification strategies (IEX/SEC/TTF) and always adhere to international standards and guidelines when available. This results in recombinant proteins with exceptional characterization, purity, and lot-to-lot consistency.
With first in industry FDA eCTD Master Files covering our leading cytokines & growth factors, we have a proven track record of prioritizing our customer’s regulatory requirements to make their drug approval process simple. Akron’s knowledgeable product, quality, and regulatory groups are committed to your therapy’s success.
Custom size and configuration vials, syringes, bags and more. We manufacture custom recombinant proteins, media and cell and gene therapy products based on your specifications, including all under cGMP.
Capitalizing on our established platform for manufacturing cGMP-compliant clinical and commercial grade ancillary products. Our broad expertise and vision are highly sought after, particularly for challenging projects which demand carefully considered approaches.