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GMP grade stable cell line development

GMP grade stable cell line development

Profacgen has an efficient, rapid and stable expression system of recombinant protein for GMP complaint production. Relying on the technology developed by R&D team, our GMP grade stable cell line development system can improve the protein expression and yield of cells, shorten about half the development time of stable cell lines, and provide a variety of special requirements such as label free expression and serum-free suspension culture. We provide flexible and high-quality services to meet the requirements of global GMP production and drug regulatory declaration.

The characteristics of stable strains include: appropriate host cells, clear source of host cells, no intellectual property disputes, sufficient monoclonal evidence, single cell image data recording, high yield, competitive production cost, good stability of cell lines, and stability test covering the whole production cycle. The source of host cells of Profacgen is clear and there is no intellectual property dispute.

According to the customer's requirements, we start from expression vector construction, followed by transfect it into the host cell to obtain a high expression cell pool, and further analysis and screening. We finally obtain a high expression stable cell line, providing high-quality cell line development services throughout the process.

Feature:

  • The high-yield cell line development platform recognized and verified by global regulators can choose commercial vectors and proprietary vectors
  • Rapid and low-cost construction of cell lines
  • Product quality analysis
  • Establishment of tertiary cell bank
  • Study on Biosafety, heredity and expression stability of cell lines

Procedure:

  • Clone screening
  • Establishment and verification of master cell bank (MCB)
  • Characterization and stability test of master cell bank (MCB)
  • Gene stability test of master cell bank (MCB)
  • Establishment and verification of working cell bank (WCB)
  • Characterization and stability test of working cell bank (WCB)
  • Gene stability test of working cell bank (WCB)
  • Cell bank transfer

Our advantages:

  • Latest technology, double resistance screening system, comprehensively improves the success rate of constructing high expression stable cell lines.
  • Rigorous cell source: traceable cell source and commercialized culture medium.
  • Broad expression objects: recombinant monoclonal antibodies, proteins, antibodies or protein fragments.
  • Stable and high yield: the recombinant monoclonal antibody can reach 8g/L, 2-4 × 107cell/mL.
  • Whole process technical support.

With years of project experience in Pharmaceutical Contract Development and Manufacturing Organization (CDMO), we can help you achieve faster time to market. Profacgen looks forward to cooperating with you.

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