Host cell protein detection and quantification products.
Development Stage: Final product, Validation
Industry: Healthcare, Medical Devices, Diagnostics
At Infinikit, we are focused on tailored design and development of HCP test kits and selling them to our target market through case-based or long-term contracts. We are focused on three main pillars for creating value for our clients
We provide process-validated and tailored HCP assays to quantify HCPs throughout a product’s lifecycle. During the early stages of product development, HCP assay development and quantification services will be provided. As the process is optimized, the assay will need to be adjusted. Based on the amount of optimization, the assay may need to be developed again from scratch to ensure validity and suitability. Once process optimization is complete, the assay will be validated for the final process, and the final assay will be provided as a kit for in-house use by the customer.
Problems to solve
Quantitation of HCPs is one of the core requirements of every biopharmaceutical production process. The composition of HCPs depends on varying factors, including cell line, culture media, feeding strategies, purification strategies, etc. Hence customized assays for each bioprocess are needed. We are focused on developing HCP quantification assays tailored to a specific bioprocess. These assays will be designed parallel to process development and specific to the target process. It will allow precise quantification of particular products’ HCPs.
Developing such assays is time-consuming and challenging, and validating the assays and their changes in sync with the changes in the process can be a burden. Our company will facilitate this by focusing on developing and customizing such assays. Since the assay is specific to the process, it can be easily assessed, validated, and customized to potential changes in the process.
- CHO HCP ELISA KIT:This kit is designed and produced to measure the impurities of Chinese Hamster Ovary (CHO) host cell proteins in recombinant pharmaceutical products.
- E.COLI HCP ELISA KIT: This kit is designed and produced to measure the impurities from High-five host cells, including protein left over from cell lysates.
- HIGH-FIVE HCP ELISA KIT: This kit is designed and produced to measure the impurities of E.coli host cell proteins in recombinant pharmaceutical products in the E.coli expression system.
We take specific standardized measures that include producing and purifying HCPs and antibodies, ordering the required materials, designing the test according to the client’s needs, designing and developing the kit, performing validation assays of the kit, and documenting the kit as a final step. The high costs associated with HCP testing solutions can be a huge barrier for the global market. Many companies spend a lot on testing for contaminants throughout the development to avoid financial losses. Infinikit’s competitive advantages are built on the competitive pricing of custom-designed test kits, which together became a competitive advantage in the market. Based on a deep understanding of the biopharmaceutical industry, we are focusing on creating a differentiated product or service with custom design in addition to a highly competitive pricing structure to build our competitive advantages.