LuinaBio provides a comprehensive manufacturing solution for both biological and small molecule drugs. We offer manufacturing services that include:
- Biopharmaceutical contract manufacturing
- GMP manufacture of recombinant proteins
- Small molecule synthesis for human and veterinary use
- Production of GMP material for pre-clinical studies and Phase 1, 2 and 3 clinical trial material batches
LuinaBio understands the complexity of protein biosynthesis. As experts in development and manufacture of both small and large-scale proteins, we welcome the opportunity to support you at every stage of your product life cycle. Our scientists understand the steps in transcribing the information contained in the molecule’s DNA to the necessary RNA, then translate the information into a specific amino acid sequence.
From here, our laboratories can assist with post translational modifications to activate or deactivate the proteins as needed to suit particular needs. Our services include the expression and identification of the target protein, purification and refolding.
Should your protein API needs increase significantly, we can help you avoid the common bottlenecks and pitfalls associated with scale-up and multi-kilogram manufacturing through regulating cellular functions, ribosome profiling and optimized translation.
Other key variables that distinguish a valuable partner in manufacturing include timeliness, efficiency, flexibility and related organizational expertise. LuinaBio strives to have a thorough appreciate for the entire scope of what is going on with your project. We have a reliable and professional project management capabilities, with individuals who are capable and empowered to make decisions.
From early-stage development through commercial market supply, we are ready to meet your immediate and long-term needs with innovative and safe solutions. Our full range of client support services include:
- Project management
- Manufacturing advice
- Process validation
- GMP documentation preparation
- Regulatory advice
- CMC or dossier package development
- Product labelling
- Product distribution
- Stability studies