Technology

Analysis for Biopharmaceuticals and Middle Molecule Drugs

Biopharmaceuticals and Middle Molecule Drugs have been rapidly growing in the market in recent years. SPERA PHARMA also possesses analytical capability for Biopharmaceuticals and Middle Molecule Drugs.

Analytical Method Development/Validation and Stability Study for Biopharmaceuticals/ Middle Molecule Drugs

SPERA PHARMA offers analytical method development and validation for quality control of biopharmaceuticals, including antibody drugs, and middle molecule drugs, such as oligonucleotides and peptides, as well as the release tests for clinical trial materials. SPERA also possesses capability to conduct stability studies to assure stability of these drugs.

Characterization/Comparability Evaluation for Biopharmaceuticals/Middle Molecule Drugs

Since biopharmaceuticals and middle molecule drugs have complexed heterogeneity, characterizations are essential to assure the safety and efficacy. In addition, in the case that manufacturing procedures, scales, and formulation for DS/DP are changed, comparability evaluation before and after the change should be performed.
SPERA offers characterization and comparability evaluation between lots, which are especially important for biopharmaceuticals and middle molecule drugs development. SPERA will select and evaluate optimal analytical methods and support your drug development.

Our principle analytical services are listed below.

• Peptide map　(including sequence analysis and post-translational modification analysis by LC/MS/MS)
• Purity/Oligosaccharide/Charge valiant analysis by capillary electrophoresis
• Charge valiant analysis by ion exchange liquid chromatography and imaging-isoelectric focusing electrophoresis
• Potency test by cell-based assay/ELISA/surface plasmon resonance (SPR)
• Quantitation of aggregates and molar mass determination
• Proteinous impurity analysis: residual host cell protein/Protein A quantitation by ELISA
• Comprehensive host cell protein analysis by 2D-LC/MS
• Quantitation of DNA/RNA by qPCR/ddPCR