YURiA-PHARM performs full-cycle development of recombinant protein-based therapeutics.
We integrate and have full control of all development activities for biopharmaceutics: from discovery to pilot production. That includes:
- Expression vector architecture design;
- Product-specific expression library screening;
- Stable cell pools generation;
- Stable clonal cell lines generation;
- Product CQA-guided clonal cell lines screening;
- Upstream process development (including high-density intensified and continuous processes);
- Purification process development (including batch and continuous operation modes);
Process scale-up and pilot manufacturing;
All activities are supported by state-of-the-art analytical technologies with in-house Quality-by-Design- developed analytical procedures.
Our expertise is based on diverse experience in engineering and expression of recombinant protein therapeutics such as mABs (produced in CHO and SP2/0 as well), fusion proteins, including such difficult-to-express proteins like TGF-b-family growth factors etc.
We don’t just utilize state-of-the art methodology during discovery and process development , but also create proprietary solutions, aimed at increasing efficacy, reducing time-to-market and develop approaches tailored to every product.
See our key proprietary bioprocessing solutions in action
- CHO DG44-based production cell line
- Cell line specifically adapted for high-cell density cultivation
- Specifically designed DHFR selection system for low-concentration MTX, with no amplification step, high-producing stable pool selection
- Demonstrated engineering of cell lines for specific CQAs optimization (glycosylation modification, cotranslational protein processing) allows de-risking of biosimilar development projects
- Optimized high-yield FACS-based cloning strategy with flow cytometry-based single-cell productivity assessment
- PUZZLEX Expression Vector Platform
- Modular assembly vector platform allows seamless generation of barcoded vector libraries for stable pool transfection
- Hundreds of experimentally validated modules (promoters, UTRs, signal peptides, polyadenylation signals etc.) ready to be cloned into expression vectors
- Solid-based vector assembly allows generation of multicistronic vectors (up to four cistrons experimentally verified) in 384-plate format
- Fully automated hands-free assembly, operated by automatic liquid handling system
- COMPREHENSIVE clonal cell line profiling platform (low-flow-based)
- Critical quality attributes assessment platform at nanogram product scale
- Primary sequence confirmation, identification and quantification of glycoforms, clipping, oxidation/deamidation profiling, and assessment of other important analytical characteristics
- Ability to perform CQA profiling early during the mini-pools/clones scaling process
- Perfusion and continuous capture manufacturing process
- Established and experimentally validated state-of-the-art scale-down perfusion process models (SpinTubes, ambr15 microbioreactors, 3L TFF/ATF perfusion system)
- Perfusion process optimization guided by design-of-experiment methodology
- Comprehensive metabolomic profiling of culture media and producer cell lines to guide media and process optimization
- 2 column-continuous product capture technology allows most efficient utilization of affinity capture media, while minimizing hold and processing times, CAPEX/OPEX and facility footprint
YURiA-PHARM has developed and qualified a comprehensive set of platform analytical methodologies, capable of providing maximum information on the recombinant protein product quality that may be necessary for future development:
- UHPLC – Intact mass-spectrometry (reduced, nonreduced, after fragmentation (papain, IdeS));
- Peptide mapping with UPLC-MS/MS or CE-MS/MS separation, reduced, non-reduced;
- CZE, cIEF, CE-SDS;
- HILIC-UPLC, CE, PGC-CHIP-based glycoprofiling;
- DSF (high-order structure profiling)
- FcRs, C1q, other binding kinetics profiling;
YURiA-PHARM has also developed a unique analytical solution, based on low-flow chromatography system for comprehensive characterization of CQAs for a target product utilizing multiple-attribute method (MAM) approach at the earliest stages of pools and clones selection (COMPREHENSIVE platform) to perform data-driven decision on producer cell line selection for research and masteer cell banks. Apart from the internal projects, our analytical platform can perform stand-along analytical tasks to support your project needs.
YURiA-PHARM is developing a unique two-stage phage display platform for antibody affinity selection.
YPhAGE platform allows screening of binders in a full-size format early in a discovery campaign without losing the diversity advantage of phage libraries.
All risks and additional time/cost, associated with humanization, are eliminated by direct utilization of the human IgG framework.
Our facilities allow us to sample diversity libraries of 10^11 and support further BLI-based high-throughput epitope binning. With that we are able to select pools of the most optimal binders while substantially reducing the risk of process development issues due to the full-size IgG format.
Each selected candidate is fully profiled according to:
- binding kinetics and specificity (BLI, flow cytometry, bioassays);
- activity (FcRs, C1q binding, ADCC, CDC);
- manufacturability assays (SEC-HPLC-TDA, DSF, Intact MS etc.)
The workflow allows seamless generation of stable cell pools for large-scale production of selected antibody candidates.
Currently, platform-demonstration studies on selected antigens are under execution.
We are looking for collaboration on your target to exploit the advantages of the YPhAGE workflow.