HiTech has decades of experience in Vaccine, Therapeutic Antibody and Biologicals assay development and providing services in these areas to its clients. An orthogonal approach is used to develop and implement product quality parameters which include but not limited to:
Aggregates and Purity: Size Exclusion Chromatography
Variants: Cation exchange Chromatography
Glycosylation : Anion Exchange and RP Chromatography.
Identity and Consistency : LC or LC/MS Peptide Mapping
Amino Acid Analysis ; RP/IEC
Residuals: GC/LC
Product Related Impurities
Process Related Impurities
Deamidation, Oxidation determination
Host cell proteins
Media Components