Scaling Up - Low Yield RUO Protein to Industrial GMP Clinical Product
The customer had generated Research Use Only (RUO) quality protein at a small scale. The protein performed as needed, but the yield (1 mg/L) would not support their grams per year need. In addition, the customer required the protein to be generated under Good Manufacturing Practice (GMP) conditions to support ex vivo therapeutic use.
Solution for GMP Project
Bio-Techne received the customer’s proprietary plasmid and applied our decades of recombinant protein development expertise to enhance expression levels and optimize the purification strategy. Once RUO protein could be generated to the agreed specifications and at sufficient scale, the customer ran equivalency tests of the product in their application to ensure satisfactory performance. With consistent activity and scale achieved, we leveraged our robust Quality Assurance capabilities to establish the documentation and process validations required to convert from RUO to GMP. The product was generated in our ISO-certified, FDA-regulated headquarters facility in Minneapolis, USA under stringent Quality SOPs. To support the customer’s Investigational New Drug (IND) application, without revealing Bio-Techne’s trade secrets, a Drug Master File (DMF) was created in collaboration and submitted to the FDA.
Current GMP Production Status
The GMP protein has been manufactured at industrial scale and is currently being administered ex vivo as part of a Phase 1 Clinical Trial. Bio-Techne exclusively manufactures this product for our partner and is working to generate more of their targets. The customer was pleased with the time it took and the efficient collaborations efforts between the teams.
Good Manufacturing Practices (GMP) Products and Services
Challenges with recombinant protein development or manufacturing? Leverage Bio-Techne to shorten timelines and increase success rate.