Biopharmaceutical analysis services

 

Category: *CRO

Exhibitor: MITHRA BIOTECHNOLOGY INC.

Booth No: N/A

 

Characteristic

 

Mithra offers full characterization plans in accordance with ICH Q6B to assist biopharmaceutical development from discovery, CMC preparation, registrations, manufacturing to clinical levels.

Biopharmaceutical analysis services:
1. Primary structural characterization and physicochemical property
2. Biosimilarity and comparability study
3. Protein research and customized methoddevelopment
4. Post-translational modification
5. Biomarker analysis
6. Glycan analysis
7. Protein quantification
8. Protein drug analysis (mAb，ADCs，Peptide，Hormones)

Instrument:
Quadrupole-Orbitrap Mass Spectrometer
 Thermo Scientific Q Exactive

Quality certificate:
USFDA Good Manufacturing Practice (GMP) inspection in 2017.
(No observation)

 

Other Products

 

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  Bioavailability and bioequivalence study

• 

  Site Management Organization

• 

  Pharmaceutical analytical services

• 

  Bioanalytical services

• 

  Pharmacokinetic study

• 

  Agency

• 

  Clinical trial services

 

 

 

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