Monoclonal Antibody Production

Highest Quality cGMP Antibody Production Services

Leinco Technologies offers the highest quality small and large-scale mammalian cell culture of HEK-293, CHO, NS0 and hybridoma cells for in vitro production of monoclonal antibodies (mAb) and recombinant antibodies. In vitro monoclonal antibody production platforms for small and large scale capacities utilized at Leinco utilize proven and highly reliable technology for quality antibody production. Cell culture work and bioreactor production are performed in dedicated biopharmaceutical cleanroom suites with standard operating procedures ensuring high-quality purified antibodies. Leinco is an ISO9001.2015 certified company and all manufacturing data is recorded in cGMP compliant batch records.

Multiple Upstream Production Platforms

A key factor to expedite delivery and reduce production costs is the availability of multiple scale upstream production platforms. Leinco can fulfill any production need while using either Steam In Place (SIP) stirred tank, packed beds, GE Life Science WAVE Bioreactors™ or proprietary single-use hollow fiber XP2000 systems. In cases where projects are in the proof of concept stage, In vitro antibody production can be performed in roller bottles or shake flasks.

  • For B cell hybridomas (<250 milligrams) – roller bottles are a perfect choice and single-use platform.
  • For milligram quantities of recombinant antibodies – shake flasks are often utilized followed by IMAC or other purification methods.

For large scale production quantities – steam in place (SIP) stirred tank bioreactors or hollow fiber systems are available in dedicated cleanroom suites for each product.

Bioreactor Scale Bioreactor Estimated Production
14 Liters Stirred Tank 30 g
7.5 Liters Stirred Tank 25 g
2 Sq. Meters Hollow Fiber 5 g
1-3 Liters Roller Bottles 100 – 250 mg
1-3 Liters Shake Flask 5 – 100 mg
20 Liters Steam In Place (SIP) 250 mg – 5+ g

Cell Banking and Cell Line Optimization

Leinco Technologies provides cell line banking, mAb production optimization, and adaptation to specialty culture media for mAb production. Leinco has a dedicated unit at the St. Louis facility that develops stable B cell hybridoma cell lines, creates master cell banks and working cell banks for use in IVD diagnostics and biopharmaceutical manufacturing. Cell lines are sub-cloned and specific productivity rates are determined to maximize protein expression. Serological testing and dual-site storage of cell banks is available.