We offer a broad spectrum of analytical assays for both process development and quality control (QC) that characterize and determine:
- Potency (for example genome copy titer, infectious titer [TCID50, EID50, Plaque assay, ICC], ELISA titer, transgene expression, OD260; other product-specific potency assays)
- Identity (for example by PCR, RT-PCR, Western blot, SDS-PAGE, restriction-enzyme mapping)
- Contaminants (endotoxin, bioburden)
- Process residuals (e.g. host cell protein ELISA, host cell DNA by qPCR, BSA ELISA, Benzonase ELISA, SaltActive Nuclease [SAN] ELISA, Insulin ELISA, affinity-resin-leachable ELISA)
- Physico-chemical assays (pH, osmolality, residual moisture)
- Other compendial assays (appearance, CCIT, extractable volume, visible particles)
We transfer and establish product-specific assays form our customers and offer qualification and validation of these assays as and when required.
Some assays are outsourced to audited select partners and managed fully by Vibalogics to keep the communication network simple and effective. We ensure complete transparency through this process.
All GMP assays at Vibalogics are performed to standard operating procedures (SOPs) to ensure the highest level of reproducibility and confidence in the results obtained. Our analytical services are also offered as a stand-alone service.
We provide a transparent and consultative partnership for the most complex virotherapy treatments.