Analytical Strategies for Biosimilars
Management of cGMP facility calls for a strict monitoring all factors including analytical strategies, formulation procedures, packaging etc. For biologic products establishing comparability and interchangeability is a big hurdle. For this purpose employment of suitable analytical approach, bioassay, protein analysis, potency testing, safety assurances are highly important. LC/MS analysis for biologic products, characterization of biologics, peptide mapping, Isoelectric Focusing and Capillary Isoelectric Focusing, SDS-PAGE, Thermal Analysis, Particulate Matter Analysis, Thermogravimetric Analysis are some methods commonly used for analysis of biologics and biosimilar products.
On average, facilities outsource 32% of their analytical testing/bioassays (up from 28%) meaning that close to one-third of analytical testing is estimated to be outsourced by the industry.
- Biosimilar multimodal techniques
- Biosimilar bioanalytical methods
- Bioassay for comparability and potency testing
- Biosimilar LC/MS analysis for discovery, preclinical, and clinical programs
- Biosimilar GMP protein analysis
- Biosimilar electrophoresis
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Analytical Strategies for Biosimilars Conference Speakers
Recommended Sessions
- Analytical Strategies for Biosimilars
- BCS and IVIVC Based Biowaivers
- Biobetters
- Bioequivalence Assessment
- Biologic Drugs
- Biological Medicine
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- Clinical Development of Biosimilars
- Consequences of Brexit on Biosimilars
- Current Challenges in Developing Biosimilars
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