Vector Protein Characterization

Because of recent rapid development for cell and gene therapy field, the need to develop appropriate analytical tools has become increasingly evident. Because of their intended use in patients, gene therapy products must meet rigorous safety guidelines highlighting the importance of well-characterized analytics. We have investigated the use of new analytical technologies to perform timely measurements of the critical quality attributes allowing for better understanding and control during the manufacturing process. For cell and gene therapy, one critical component is the vector used to introduce the gene of interest. Most commonly, viral vectors, derived from lentivirus (LV), adenovirus (AV) or adeno-associated virus (AVV) are used for these therapeutics. One of the challenges of characterization and quality control testing of viral vectors is their high degree of complexity. The viral vectors normally have a structure more complex than the most complex recombinant proteins. Developing accurate and reproducible analytical tools for characterization of vector proteins in order to monitor quality attributes is important for ensuring a safe, high quality, consistent and efficacious product.

We provide following services for vector protein characterization:

Quality Attribute Technique
Identity Confirm presence and identity of viral vector Mass spectrometry (MS), PCR
Charge Variants icIEF
PTM UPLC-MS
Purity Process-related impurities MS, Chromatography
Host cell-related Impurities Host cell proteins: ELISA
Stability Aggregate formation SEC-MALS