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In vitro Monoclonal Antibody and Protein Production in Bioreactors
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Leinco Technologies has extensive experience in large scale mammalian cell culture of hybridoma, CHO, NSO and HEK-293 cells for production of monoclonal antibodies and recombinant proteins using steam in place (SIP) stirred tank, packed bed or hollow fiber bioreactors. In cases where projects are still in the proof of concept stage, In vitro production can be performed in roller bottles or shake flasks. Bioreactor production is available at small and large scale in our production facility located in St. Louis, Missouri USA. Work is performed in dedicated cleanroom suites using standard operating procedures and manufacturing data is recorded in cGMP compliant batch records. Master manufacturing files are archived and bio-analytical lot release testing records are provided to clients.
Clients may elect to use their own working cell bank and upstream production process or take advantage of Leinco Technologies bioprocess development and scale-up services. Upon request, a detailed proposal tailored to the specific project is presented to clients for their consideration.
A variety of cell culture media is available to produce monoclonal antibodies and recombinant proteins. Leinco scientists can optimize mammalian cell lines for productivity and adapt them to grow in serum free or protein free, chemically defined animal origin free media.
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Bioreactor Production
A key factor to expedite delivery and reduce production costs is the availability of multiple scale upstream production platforms. For Hybridoma cells where production requirements are less than 500 milligrams, roller bottles may be used. For milligram quantities of recombinant proteins, shake flasks are often utilized followed by IMAC or other purification methods. However, when larger production quantities are required, steam in place (SIP) stirred tank bioreactors or hollow fiber systems are available in dedicated cleanroom suites for each product.
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Bioreactor Scale
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Bioreactor
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Estimated Production in 60 Days
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30 Liters
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Stirred Tank
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100 g
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14.0 Liters
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Stirred Tank
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30 g
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7.5 Liters
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Stirred Tank
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25 g
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70 Sq Ft.
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Hollow Fiber
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25 g
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2.0 Sq. Meters
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Hollow Fiber
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5.0 g
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Project Management
A successful partnership is based on good communication resulting in an understanding of the client’s expectations and timelines. Once the scope of work and product specifications is determined, the project is initiated and clients are provided with weekly manufacturing status reports. A secure portal into our online project management system is avaliable for real time project updates.
Cell Banking and Cell Line Optimization
We provide Cell Banking, Optimization and Adaptation for In vitro monoclonal antibody and recombinant protein production. A dedicated unit within our US facility develops stable cell lines, creates master cell banks (MCB) and working cell banks (WCB) for use in manufacturing. Cell lines are sub-cloned and specific productivity rates determined to maximize protein expression. Serological testing and dual-site storage of cell banks is available.
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