DISCOVER RESEARCH & DEVELOPMENT > RESEARCH AREAS

Our major Research Areas

Nanogen's successes in research & development continuously strengthen our portfolio of providing high quality products with reasonable prices. Our drug discovery focuses on five major categories: Cytokines, Hormones and Growth Factors, Enzymes and Recombinant Antibodies.


Cloning

The genes encoding for desired proteins were artificially optimized and synthesized based on the protein sequence data available from our research lab. This is a novel method which reduces the time required to isolate the gene but still gives a result as accurate as the conventional method.

Nanogen has developed universal expression vectors for high expression and facilitation fermentation for industrial production of a large quantity of proteins and easy to switch to desired proteins.

Nanogen’s proteins are produced either by Escherichia coli or Chinese hamster ovary cells based on the glycosylation and complicity of the molecules. Gene transfection protocols applied in Nanogen was designed and validated to get the highest expression level. Selection procedures were performed strictly to get the highest expressed clones. Master cell banks and working seed lots of cells were done, stored and test strictly based on the cGMP guidelines.

Process development

Nanogen scientists have considerable experience in process development under cGMP including:

  • Selection of clones
  • Cell line evaluation and stability
  • Cell line adaptation
  • Medium development in animal-free components
  • Development and optimization of robust and scalable processes
  • Development Cell Banks
  • Up-stream processing
  • Down-stream processing 
  • Formulation 

Proper biopharmaceutical formulation is critical to an APIs performance. At Nanogen, we design delivery systems and excipients to work as a unit. From liquid vial to lyophilized, they are all means to the same end: getting the right amount of API to the right place at the right time.Our formulation development labs are extremely well equipped and are supported by in-house GMP/GLP analytical facilities and ICH stability programs.

Stability testing in long-term storage, accelerated or stress are performed and recorded following current ICH or GMP guideline to ensure the highest quality of our drugs.

Assay development

The development and use of a validated assay for a biopharmaceutical product is a critical part of the product development process. With Nanogen’s current highly qualified personnel, lab equipment  and the collaboration with some out-sourcing experts, Nanogen’s R&D department are able to develop, maintain and validate the best practice assay, statistical consultancy in line with ICH, US Pharmacopeia and European Pharmacopeia guidelines.

  • Protein identification test
  • Immunoassay
  • Impurities testing
  • Protein molecular weight testing
  • In-vitro bioassay
  • In-vivo bioassay
  • Glycosylation
  • Peptide mapping
  • io burden testing
  • Endotoxin testing
  • Abnormal toxicity testing
  • Host-cell DNA residu
  • Host-cell peptide residue

Pre-clinical trial studies

Nanogen Preclinical Safety Testing includes a wide range of pharmacokinetics, acute toxicity, repeat dose toxicity, genotoxicity, immunogenicity, and developmental and reproductive toxicology studies.

Other research & development

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