Upstream Processing DeVELOPMENT
From cloning genes of interest to fermentation at various scales, our Upstream Processing Lab offers comprehensive services to kickstart your product development journey.
- Cloning gene of interest in high expression vectors and selection of host
- Cell bank preparation- RCB and MCB
- Media optimization
- Fermentation- microbial, yeast and mammalian; small scale and lab pilot
- Optimization of lysis and clarification
Downstream Processing DEVELOPMENT
Utilizing multiple strategies of purification techniques including chromatography and buffer exchange, our downstream processing lab ensures the isolation of pure recombinant proteins.
- Selection and optimization of Chromatography resins based on protein of interest
- Method development and validation of protein purification strategies using different chromatography techniques (affinity, ion exchange, size exclusion)
- Buffer exchange using TFF system
Formulation
Our Formulation Lab specializes in optimizing liquid and powder formulations, ensuring stability and efficacy of your product.
- Selection of excipients and optimization using statistical methods
- Liquid and powder formulation
- Packaging and fill finish in container closure system
- Stability evaluations as per ICH guidelines
Bioanalytical DEVELOPMENT AND CHARACTERIZATION
Comprehensive platforms offering analytical services including method development and validation for quantitation of analytes, analysis of in-process samples, characterization of drugs, purity profiling etc, ensuring consistency of the processes and the quality of the product.
- Binding assay using ELISA and Western blotting
- Characterization by HPLC (RP, SEC)
- Cell based bioassay (MTT assays, HUVECproliferation assays)
- Product and Process Impurity analysis (residual HCP, HCD, Endotoxin, residual antibiotics, HMWs and degraded products)
- Sterility testing
- Stability evaluations for drug product and drug substance
- Method development and validation as per ICH guidelines