Purification of Recombinant Proteins and Antibodies
Leinco Technologies has developed robust multi-step antibody and protein purification processes that can be used to purify recombinant proteins and antibodies, which have potential for use in early discovery research, preclinical trials, therapeutic applications, In vitro medical devices, and much more. Protein production is available on a small-scale laboratory level or may be scaled up for large-scale commercial manufacturing. Development of the appropriate protein purification method is based on the final product application and predetermined bio-analytical protein specifications. Typically, a robust procedure beginning with protein A affinity chromatography followed by other proprietary chromatography steps result in a highly pure antibody preparation. For In vivo functional studies or preclinical trial materials, procedures resulting in preparations free of antibody aggregates, DNA, viruses, leached protein A and low endotoxin levels are available. For more information regarding In vivo ready material for preclinical research, click HERE.
Downstream Processing Components for Antibody and Protein Purification
- Protein A Affinity Chromatography
- Protein G Affinity Chromatography
- Ion Exchange Chromatography
- Antigen Affinity Chromatography
- Immobilized Metal Affinity Chromatography (IMAC)
- CHTTM Ceramic Hydroxyapatite Chromatography
- Hydrophobic Interaction Chromatography (HIC)
- Size Exclusion Chromatography (SEC)
- SDS-PAGE Analysis for Purity
- FPLC Analysis for Purity and % Aggregates
- Isoelectric Focusing (IEF) for Identity
- Concentration Determination
- Protein A / Antibody Ratio
- Mycoplasma Testing
- Endotoxin Testing
- Biological Activity
- pH Determination
- Freeze Thaw Recovery
Using a proprietary transgene expression systems in mammalian cells like CHO or HEK293 cells, Leinco has the ability to produce high-purity levels of proteins and antibodies. For more information click HERE.
Using multiple bioreactor platforms and fermentation tanks for E. coli. enables small scale and large scale production. For more information about the protein production process click HERE
The antibody and protein purification process is performed using standard operating procedures (SOPs) and cGMP compliant batch records. Upon completion of a recombinant protein purification batch, a master production file is archived and bio-analytical lot release testing records are provided to clients.