IVD Manufacturing

In vitro Diagnostic (IVD) Testing Industry Partner

Leinco Technologies offers large and small-scale IVD antibodies and protein production at lower costs along with a highly experienced scientific staff and state of the art biotechnology facility. Manufacturing of proteins and antibodies at Leinco is confined to class 10,000 dedicated cleanroom suites all located in St. Louis Missouri. Leinco is ISO 9001:2015 certified and cGMP compliant subject to numerous annual quality audits.

Leinco IVD Production Process

Added Value to Our Partners

  • Cell line Development and Cell Culture: Each product starts off in cell culture where the seed culture is prepared for transfer to bioreactors operated in dedicated cleanroom suites. Leinco develops and manufactures its own cell culture media. Separate and dedicated downstream suites are also used to clarify and concentrate bioreactor harvest.
  • Scale-Up Production: Leinco utilizes class 10,000 biotechnology cleanrooms for manufacturing antibodies and proteins. Multiple bioreactor platforms are available for mammalian cell culture and protein production runs: small scale static rollerbottle production, wave/Rocker single use bioreactor systems, hollow fiber bioreactor systems (developed in house), motion platform cell culture apparatuses, or tank bioreactor systems for continuous perfusion harvesting.
  • Purification & Chromatography Methods: Using validated efficient procedures and custom built equipment, Leinco’s purification Department optimizes antibodies and proteins to meet product specifications.
  • Quality Control & Bioanalytics: Tests are conducted to assure each active diagnostic component manufactured meets the required purity and functional specifications established for the product and set by the customer.

Cryo Storage Facility and Hybridoma Cell Line Optimization

In addition to IVD antibodies and protein production, Leinco offers the preparation of highly optimized master cell banks (MCB’s) and working cell banks (WCB’s) with offsite storage capabilities. Cell line optimization and banking is an important component to achieve lot to lot consistency and long-term production requirements. Testing is performed on each cell bank to assure cells are mycoplasma negative and free of other adventitious agents.

Cell Banking Benefits

  • Automated cryogenic refrigeration equipment
  • All unit contain local and remote alarm systems
  • Cell lines are maintained at -150ºC or less
  • Restricted access to freezers
  • Electronic inventory system
  • Dual site backup available

Hybridoma Cell Line Optimization Benefits

  • Optimization of cells for cGMP manufacturing
  • Quality Control Checks – viability, clonality, sequencing, sterility, pre/post IEF, pathogen (-), mycoplasma (-)
  • Certification free of adventitious agents including:
    • Master Cell Bank
    • Pathogen (-) reporting
    • Mycoplasma (-) reporting provided
  • Freeze 30+ vials or more
Cells banking, liquid nytrogen tank