Regulatory Considerations
As Isolere brings its reagents to market, safety and quality are a top priority. Unlike traditional affinity resins, Isolere’s products are recombinant proteins – no scaffold, no bead, no chemical conjugation. As small proteins <50 kDa in size, these reagents can be manufactured under GMP and delivered as fully sterile products. As we begin transitioning from research- to GMP- grade products, our priority is to ensure the delivery of reliable, robust, safe, and high quality products that solve your manufacturing pain points. Key aspects of our plan for delivering GMP suitable reagents are outlined below.
ISO9001-certified manufacturing facility
Cleanroom environment for final purification step and fill-finish
Production process 100% animal-origin free
Quality management system
Certificate of analysis and manufacturing process modeled after the USP monograph for Protein A: USP <130>
Drug Master File submission or Regulatory Support File to be completed prior to launch of GMP-grade product
Commercially available, application-specific residual ELISAs