The supply of critical raw materials for cell therapy manufacturing must fulfill the need for cost-effective, safe and functional products that provide reliable and reproducible performance.
In case of cytokines, these products are proteins that must fulfill the need for stability, functionality and be contamination-free. Within stability and functionality, considerations of three-dimensional structure and affect on protein function, concentration-dependent viscosity and stability and storage conditions.
One of the critical, and most overlooked, aspects of the supply of cytokines for cell therapy manufacturing is the fill/finish process. As cell therapy products advance through the development pipeline, the need for cGMP-compliance increases, as does the quality specification needs for the product.
Within cGMP cytokine suppliers, however, commitment to sterile fill/finish processes is limited. While the consensus that extensive documentation and product validations for the supply of cGMP-grade cytokines are needed exists, there is still a gap in the industry when it comes to supplying these products finished and packaged with robust sterility claims.
This is something Akron has recognized early — that is part of the reason why Akron is unique among cytokine suppliers as Akron is able to fill the need for small or large scale, fully-cGMP-compliant cytokines for cell therapy manufacturing that are filled and finished within a sterile, pharmaceutical environment.
Akron’s sterile manufacturing facility ensures product containment while providing an aseptic manufacturing environment. This includes sterile filtration and container-closure filling unit operations. Extensive QC testing, which includes not only visual inspection, but in-process and release testing for an extensive panel of assays – host cell DNA and protein contamination, purity, biological activity, endotoxin and mycoplasma – ensures extensive quality claims can back up Akron’s cytokines.
Moreover, labeling, packaging, shipment and cold-chain management processes all adhere to cGMP guidelines.
This is important because considerations of cytokine safety are critical to ensure consistent, and safe, performance of the cell therapy product as the therapy is scaled up through preclinical and clinical development.
In other words, not all cytokine suppliers are the same, and it is important to understand why that is the case and what level of quality your cytokine supplier is really providing.