Process Validations
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Process Validation 1
We use biochemical assays to validate our protein refolding. For example, inhibiting the intended targets means refolding has been perfect. To quote an example, for anti-coronavirus biologics, the inhibition of the 3-chymotrypsin like protease is a must against known benchmarks.
Process Validation 2
We also use in vitro cell assays using either TCID50 or PFU reduction to determine if the refolded antiviral proteins can reduce virus titers as well a known benchmarks. To further validate, we can also use RT-PCR to chek viral titres.
Process Validation 3
We also use a Tilapia fish model that has been infected with TiLV or Tilapia Lake Virus to determine if any antiviral protein produced by our novel bioprocess system can work in an in vivo system as animal models are much more convincing than cell assays.
Process Validation 4
CE-SDS or capillary electrophoresis – sodium dodecyl sulphate has greater precision and reproducibility than HPLC (high performance liquid chromatography) in many cases. Thus, this system is quick and efficient for QA/QC as a robust technique that is well accepted under GMP conditions of manufacturing.
Process Validation 5
LC-MS-MS or Liquid Chromatography with tandem mass spectrometry is the highly sensitive “Gold-Standard” for determination of protein purity. After we complete our in-line QA/QC, the final product before release must pass this final stage of product validation.
Process Validation 6
Circular Dichroism or CD is widely applied in the determination of the secondary structure of the target protein after it leaves our bioprocess system. It is a rapid method for final product release validation using right/ left circularly polarized light to complete our strict validation process of protein refolding.
