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USA: 45-1 Ramsey Road, Shirley, NY 11967, USA
Europe: UK - Germany
Call us at:
USA: 1-631-381-2994
Europe: 44-207-097-1828
Fax: 1-631-207-8356

GLP-Compliant Cancer Vaccine Production

Good Laboratory Practice (GLP) is the global gold standard for conducting non-clinical health research. For pre-clinical safety studies, GLP compliance is required for the development of drugs (small molecules) and biological agents (monoclonal antibodies, therapeutic proteins, vaccines, and gene therapy agents).

Creative Biolabs adheres to the Good Laboratory Practice (GLP) research requirements for the safety and efficacy of drug candidates. Our GLP quality control system is widely used in non-clinical research to ensure consistency, reliability, repeatability, quality, and integrity of recombinant proteins, therapeutic antibodies, cancer vaccine safety, and efficacy testing.

GLP-Compliant Process Development

Creative Biolabs’ biologics process development team can develop the entire process or optimize individual steps in the previous process to ensure that the test studies meet GLP requirements. Upstream, the process development team can screen a variety of production strains to select cell lines that best express the drug. We can optimize processes such as high cell density fermentation to increase product yield and produce the highest quality products in the most efficient and cost-effective manner. For early process development, our biologics team works in tandem with the protein analysis team to ensure product integrity during the early development process.

GLP-Compliant Research Cell Line-Standard Package

Cell Line Characterization

According to document ICH Q5D ‘Quality of Biological Products: Derivatives and Characterization of Cellular Substrates for the Production of Biotechnology/Biological Products’, Creative Biolabs performs cell bank characterization on the following cell lines:

  • Master Cell Banks (MCB)
  • Working Cell Banks (WCB)
  • End-of-Production Cells (EOPC)
  • Virus Seed Stock (VSS)

For more details, please feel free to contact us for project quotations and more detailed information

We offer a variety of analytical techniques for stability testing:

Cell Banking

Combining our cell banking, antibody & protein, and vaccine engineering services, we provide GLP/cGMP-compliant cell bank to ensure our customers have access to inexhaustible phenotypically consistent cells.

  • Maintenance of a single master cell line
  • Working cell banks with low passage numbers
  • Identity confirmation by DNA Fingerprinting

Our Dedicated Efforts

  • GLP compliant procedures and clearly defined deliverables
  • GLP knowledgeable, experienced project team
  • Proper installation, maintenance and operation of facilities and equipment
  • Receiving and processing of raw materials; release of, labeling, packaging and transportation of deliverables
  • Production and process control
  • Continuous assessment and improvement

All services and products are only for lab research use, not for any clinical diagnosis or treatment.

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