Analytical Development

BioCina integrates the traditional approaches to development, qualification, and validation into the analytical method lifecycle rather than viewing them as separate entities.

Working with our customers, we define an Analytical Target Profile and establish the measurement requirements for Critical Quality Attributes. Methods are subsequently developed to be fit-for-purpose and qualified/validated to a phase-appropriate level. Throughout the method lifecycle, and as method and process understanding grows, Continued Procedure Performance Verification and change management is used to ensure that methods remain fit for their intended use.

Summary of Analytical and Bioassay Services:

  • HPLC/UHPLC with UV or FLR detection

  • Peptide mapping

  • SDSPAGE

  • ELISA, HCP, endotoxin, bioburden, enzymatic, and colorimetric assays

  • Forced degradation

  • Definition of target product profiles (TPPs)

  • Multifactorial Design of Experiments

  • Multivariate statistical analysis

Other Services:

  • Extended product Characterization

  • Stability