LakePharma’s monoclonal antibody production service provides scale up of hybridoma cell lines at volumes ranging from 100 mL to 200 L. Depending on the volume, shake flasks, roller bottles or cell factories are utilized, and all methods produce highly concentrated antibody supernatant. Client provided cell lines are expanded and cultured for production using client’s custom media or LakePharma’s standard media and protocol, typically followed by protein purification. LakePharma has extensive expertise in cell culture and expression optimization, and adherent cell lines can be adapted for suspension growth and serum-free media. Related services include cell line banking, isotyping, and variable region cloning and sequencing.
1. Client provided, or previously generated cell line is tested for contamination.
2. If cell line is free of contaminants, a small working cell bank is created.
3. A small scale expression optimization study is conducted to determine optimal production media and harvest conditions. A production cell bank is prepared using the production media selected from small scale expression study.
4. 1 liter expression is performed and harvested at the expression conditions identified in the small scale expression study. The protein is purified by protein A affinity chromatography. Elution fractions are analyzed by PAGE & Western blot and pooled based on purity metrics established with the client
Please note: production may subsequently be scaled up to 10 liters or higher to produce antibody quantities needed by clients.
Options available: low endotoxin processing (inquire), protein titer quantification (HPLC), analytical protein characterization including aSEC (HPLC), C-IEF, thermal stability analysis, mass-spec, and protein formulation optimization.
1. Hybridoma cell line (unless previously generated at LakePharma).
2. Culture conditions, including recipe for growth media.
3. Anticipated production levels, if known.
1. Cell bank
2. Purified antibody
3. Study Report
4. Certificate of Analysis