rDNA
rHCP
rProtein A
PS80 Content
Excipients Content
Endotoxin
Mycoplasma
Impurity/Safety testing
rDNA
rHCP
rProtein A
PS80 Content
Excipients Content
Endotoxin
Mycoplasma
Analysis method transfer/development/validation and validation work; Calibration and characterization of reference/DP; Stability research, comparability research work; Meet Chinese and American IND requirements
dragonsailpharma has established a variety of platform analysis methods to provide analysis method development/transfer/verification/validation for biopharmaceutical customers, and to serve the analysis of key quality attributes and process parameter optimization. The service covers a full range of physical and chemical analysis and biological activity analysis, including identification analysis, structural characterization, content and purity analysis, impurity analysis and activity analysis.
We can also provide customers with quality standard establishment services for IP, DS and DP. Stability Research Services for DS and DP; Research services for similarity and comparability of macromolecular biosimilars; Structural and functional calibration and characterization of reference/DP.
dragonsailpharma have advanced equipment and high level professional technical team, with monoclonal antibody, a variety of types such as biospecificity antibodies and fusion protein biological medicine molecular analysis experience, can satisfy the customer in drug research and development, the CMC in the field of research and production of different stages, different quality analysis requirements, and can meet the requirements of different areas, the United States and Europe in the IND.
Preclinical Pharmaceutical Research
———— Quality Research
Core Advantages
General
Basic product characteristics
Protein content
pH
Osmolality
Color
Clarity
Invisible Particles
rDNA
rHCP
rProtein A
PS80 Content
Excipients Content
Endotoxin
Mycoplasma
Analysis method transfer/development/validation and validation work; Calibration and characterization of reference/DP; Stability research, comparability research work; Meet Chinese and American IND requirements
dragonsailpharma has established a variety of platform analysis methods to provide analysis method development/transfer/verification/validation for biopharmaceutical customers, and to serve the analysis of key quality attributes and process parameter optimization. The service covers a full range of physical and chemical analysis and biological activity analysis, including identification analysis, structural characterization, content and purity analysis, impurity analysis and activity analysis.
We can also provide customers with quality standard establishment services for IP, DS and DP. Stability Research Services for DS and DP; Research services for similarity and comparability of macromolecular biosimilars; Structural and functional calibration and characterization of reference/DP.
dragonsailpharma have advanced equipment and high level professional technical team, with monoclonal antibody, a variety of types such as biospecificity antibodies and fusion protein biological medicine molecular analysis experience, can satisfy the customer in drug research and development, the CMC in the field of research and production of different stages, different quality analysis requirements, and can meet the requirements of different areas, the United States and Europe in the IND.
