Quality control (QC) testing requires the application of a broad range of analytical procedures to ensure the identity and purity of a particular pharmaceutical product. The applied methods have to be suitable to address the relevant quality attributes, sensitive and robust to ensure reliable and reproducible results.
Selvita has a proven track record in performing QC testing for recombinant drug substances, for excipients as well as for the final drug products. We perform cGMP release testing of biologics for clinical phases and for EU market release – utilizing the following assays and methods:
- Bio-/Binding Assays: Cell proliferation and cytotoxicity assays, apoptosis assays, cAMP assays, ELISA and SPR
- Identification Assays: Peptide Map, cIEF/IEF, SDS-PAGE, Western Blot and various Staining Techniques Purity Assays: HPLC, CE-SDS, SDS-PAGE, cIEF/IEF
- Content & Impurities: Protein Content (RP-HPLC, OD), Product-related Impurities (SEC-HPLC, CE-SDS, cIEF, IEX- and HI-HPLC), Process-related Impurities (residual DNA, HCPs, Tween,…)
- Compendial Methods: Appearance, Color, Clarity, Visible Particles, Sub-visible Particles, Osmolality, pH, Water by KF, Extractable Volume, CCI, Functional Tests (friction force, dose accuracy, cartridge dimension, etc), Sterility, Bacterial Endotoxines
Selvita’s comprehensive state-of-the-art analytical portfolio assures the best possible compromise between sensitivity and straightforwardness in every stage of QC method development and implementation. Our instrument park includes e.g.:
TFS QExactiveTM Plus OrbitrapTM MS; TFS TSQ AltisTM; Sciex CESI 8000 plus; TFS and Agilent HPLC/UHPLC (UV, CAD, ELSD, RID, FLD, MS); Biotechne iCE3, Agilent ICP-MS; AB QuantStudioTM 6 Flex RT-PCR System; GE Healthcare BiacoreTM T200; Biotek- and Tekan Multi-mode Microplate Readers; Panasonic CBS Isothermal Cell Lines Long Storage Systems etc.