Contact US

+86 18721174739

Email

jiyebio@jeyoupharma.com

Production services

Test Service Items

Development Services

Registration

Sales Outsourcing Services

Service Scope

Test of biological drug substance and drug product

CE-SDS (NR, R),CEX,cIEF,SEC,CZE,Binding Activity,Biological Activity,Host Cell DNA,Host Cell Protein (HCP),Protein A Residue,Protein Content,Polysorbate 20/80,Appearance,Clarity,pH,Osmolality,Visible Particles,Subvisible Particles,Extractable Volume.

Stability study

Long-term stability, accelerated stability, stress test.

Test of raw material, excipients and packaging material

Appearance, Clarity, Identification (Infrared Spectroscopy, Raman Spectroscopy), pH, Optical Rotation, Solubility, Water Determination, Assay (Content Determination), Potentiometric Titration, Melting Point, Related Substances, Subvisible Particles, Chemical Properties.

Pharmaceutical Water System / Environmental Monitoring

Pharmaceutical Water System: Acidity or Alkalinity, TOC, Conductivity, Nitrate, Nitrite, Heavy Metals, Ammonia, Microbial Limit, Bacterial Endotoxin Test Cleanroom Environmental Monitoring: Airborne Particles, Airborne Microorganisms, Settled Microorganisms, Surface Microorganisms.

Facility and equipment

  • Classified by function into Instrument Laboratory, Biochemical Laboratory, Raw Materials & Excipients Area, Bioassay Laboratory, and Microbiology Laboratory.

  • Equipped with advanced instruments and equipment, such as: Protein Simple Maurice, Roche qPCR instrument, Waters UPLC/HPLC, AB SCIEX PA800 plus, MD iD5 microplate reader, etc.

  • Testing methods comply with the ChP and USP.