Rodon Biologics offers proprietary expression technology, cell line development capabilities, upstream and downstream processing, analytics and QC experience for delivering GMP/GLP compliant processes for biomanufacturing. Rodon Biologics has a strong client-based activity with established track-record.
Independently from what stage your company is at, Rodon Biologics could help you in developing a biologics-manufacturing strategy early in the drug-development process. Rodon Biologics has in-house capability for development of biopharmaceutical products up pre-clinical stage. That includes scale-up and transfer of well characterised processes to cGMP facilities with whom Rodon Biologics has established collaborations over several years.
Rodon Biologics has a qualified (MSc, PhD level) and experienced workforce with proven skills in: Molecular biology and cell line development: cloning and expression of genes of interest, evaluation of a wide range of expression systems suitable for commercial manufacturing. Fermentation / Culture process development: evaluation of the most suitable candidates and process development for effective, consistent and robust high-yielding expression of the product. Downstream processing development: strategies for maximizing recovery and purification of the product to meet required regulatory standards. Analytical and bioassays development: tools to assure the quality (identity, purity, potency and stability) of the product and consistency/robustness of the production process. Process transfer to GMP manufacturing: our knowledge of regulatory, GMP/GLP issues and documentation procedures ensures that we can develop a process and carry-out its transfer for manufacturing in compliance with the industry quality standards. On-going collaborations with GMP manufacturing facilities give the company the scope to supply materials produced according to cGMP.