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Mammalian Protein Expression
Our novel mammalian transgene expression system has been developed to expedite the expression of recombinant proteins and monoclonal antibodies for use in early discovery research, In vivo preclinical trials or In vitro diagnostic medical devices. Our patent includes claims for compositions of matter and bioprocesses to transiently express recombinant proteins in mammalian host cells such as Chinese hamster ovary (CHO) or HEK-293 cells with high efficiency during suspension cell culture in controlled stirred tank bioreactors. We utilize a proprietary protein free cell culture media formulation that is chemically defined and animal origin free. The high efficiency of transfection using Leinco Technologies' UltraFectin-CHO reagent contributes to the high levels of protein expression realized in our proprietary expression system. Protein Expressions
Site Directed Mutagenesis
Single and multi-site directed mutagenesis services are offered to create variant candidates for characterization of potential therapeutic recombinant proteins and monoclonal antibodies, followed by mammalian transgene expression, purification and bio-analytical lot release testing resulting in low endotoxin functional formulations for use in preclinical trials. Services
 
Purification
Leinco Technologies has developed robust downstream processing and purification methods for isolating recombinant proteins and monoclonal antibodies for both In vivo and In vitro applications. Our purification methodologies are designed to assure the high purity requirements for preclinical animal studies or In vitro medical devices. Automated AKTA Design chromatography systems provide the traceability required for pharmaceutical and medical device companies. Services
 
Process Development
Innovative bioprocess development is one of our core strengths. Project goals and objectives are established with our clients and the development process is initiated. Our process development services include cell line development or optimization, media optimization, bioreactor protocols, purification methods and final formulation for long term stability. Technology transfer may include writing cGMP compliant standard operating procedures, batch records and onsite training if required. The result is an efficient regulatory compliant manufacturing procedure that can be carried out in Leinco Technologies' manufacturing facility or transferred to an alternative site. Services
In vivo Functional Formulation Proteins
Leinco Technologies has developed an extensive technology tool box for custom manufacturing of recombinant proteins and monoclonal antibodies that meet high purity standards for conducting In vivo preclinical trials. Our upstream bioreactor production procedures, multi-step purification methods and lot release bio-analytical quality testing assure that In vivo functional formulation standards are met. These standards include < 0.06 Endotoxin Units (EU)/mg, < 10 ng of Protein A/mg, > 99% monomer in the case of monoclonal antibodies, > 99% purity by SDS Page and HPLC size exclusion chromatography and virtually undetectable levels of DNA or RNA. Whether you are conducting early discovery research in an academic environment or managing In vivo preclinical trials for potential therapeutic protein candidates in industry, our high purity standards will assure that your discovery data is reliable. Services
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