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Eurofins Biopharma Product Testing Kyoto >> Services >> Method Development & Release Testing

Method Development & Release Testing

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Small molecules pharmaceutical testing

Method development

We develop method to meet customer’s needs speedily (Appropriate methods for each development phase).
Method development of related substances comply with requirement of Pharmacopeia.

 

Method validation

We offer validation services from simple validation to full validation (We provide appropriate level of services for each development stage).

 

QC testing of APIs, intermediates, and various types of pharmaceuticals

  • Properties, verification, purity testing, quantitative analysis, other characterization testing
  • Acceptance testing for raw materials and packaging materials(Documented by JP/US/EP pharmacopeia)

 

Biopharmaceutical testing

Due to the complicated structure of large molecules comparing to that of small molecules, an extensive testing with various methods is necessary to evaluate the quality.

  • Method development and validation for biopharmaceuticals
  • Release testing for biopharmaceuticals

We can perform ELISA, Cell Based Assay, and several Electrophoresis testing. Potency Assays/ Bioassays are essential for the quality evaluation of biopharmaceuticals. We have experienced scientists and analysts and well-managed laboratory environment and equipment to provide high-quality and reliable data.

 

We support your small molecules pharmaceutical and biopharmaceutical testing. Please feel free to contact us if you have any questions and requests.

 

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