The production of therapeutic proteins for use in clinical applications is stringent and rigorously controlled. A combination of complimentary and overlapping techniques is essential to demonstrate identity, structure, purity and potency of the product and assure the consistency of the manufacturing process.
At Rodon we have the experience to develop the required analytical procedures to assure product and process quality. Our team has significant expertise in all stages of biologics development: from early discovery through IND and beyond. Tests are designed in consideration of the relevant Pharmacopoeia (EU and US monographs) and regulatory guidelines (ICH, FDA and EMEA) and considering GMP practices.
We specialize in a broad range of analytical testing techniques to support characterisation and development by bringing a combination of in-house protein biochemistry, molecular biology, cellular biology, and QC experience. We also collaborate with well-established partners with extensive experience in specialized characterisation methods so that we can offer a full characterisation service.
Our characterisation services include:
• Protein concentration (A280, HPLC, ELISA)
• Protein purity analysis (SDS-PAGE, HPLC, DNA-qPCR, HCP – ELISA, Microbial, Endotoxins)
• Identity (appearance, pH, melting temperature, peptide fingerprint, western blotting, IEF, cIEF/cSDS, amino acid analysis, mass spectrometry, glycan profiling, peptide mapping, sequencing, CD, DSC)
• Potency (ELISA, Flow cytometry, SPR, cell-based assays)
We Offer More
Looking for additional services? We offer even more services than listed, contact us to find out how we can assist you. Using latest advances in Protein Technologies Rodon Biologics strives to provide the highest quality custom protein services in the industry. We work closely with you, analyze your project at the planning stage and take several approaches to ensure you get the results you are looking for.Know More