Analysis of samples from process development and process characterization studies to track yield and purity
Non-cGMP ICH stability studies for DS (liquid or frozen), in-process, and intermediate material to understand DS and process intermediate material and to establish process hold times
Forced degradation studies
Elucidation and structure studies
Establishment of DS and DP specifications and acceptance criteria
IND and BLA writing (3.2.S)
Analytical Assay Expertise
Biochemical and biophysical assays
Separation techniques for purity: Liquid chromatography (size exclusion, reverse-phase; HPLC, UPLC), CE-SDS and SDS-PAGE
Charge variant profiling: CEX-HPLC and iCIEF
Particle, sub-visible particle, and size analysis: DLS and MALS
Process impurity analysis: ELISA for residual host cell protein and qPCR for residual host cell DNA; endotoxin quantitation by LAL testing
Protein content: Spectrophotometric techniques, BCA, and Bradford assays
Structural characterization: DSC, Near and Far UV-CD
Potency assays
ELISA and cell based assays
Fine structure characterization
Mass spectrometry and LC/MS for identity, glycosylation analysis, chemical and amino acid modifications, and other PTMs
Compendial assays from USP or Ph. Eur.
QC Services
BIB can perform QC testing for DS release and formal ICH stability studies to generate data DS expiration.
