Plasma-Derived Complex Blood Factor Development

We provide end-to-end CDMO support across the value chain from Pharmaceutical Development & Manufacturing → Drug Substance Development → Blood Factor Development. Our focus is laboratory biotechnology, designing robust fractionation, purification, and characterization workflows that convert variable plasma inputs into consistent, well-defined complex blood factor drug substances suitable for downstream use.

Plasma Fractionation Process Development Service

We design and optimize plasma fractionation schemes that enrich the target complex while preserving native associations and functional states. Using cryoprecipitation, controlled ethanol/polymer precipitation, and pH/ionic strength programming, we define critical process parameters, hold times, and sequence order to maximize yield and selectivity. Scale-down models emulate temperature ramps, solvent ratios, and agitation shear to predict pilot outcomes.

Chromatography & Polishing Strategy Development Service

We construct purification trains that balance selectivity, recovery, and stress minimization. Ion-exchange, affinity, HIC, and size-exclusion are screened with resin/pH/salt DoE to manage co-purifying proteins and remove activated species. For multicomponent concentrates (e.g., PCCs, vWF–FVIII), we tune conditions to maintain desired stoichiometry and multimer distributions. Low-shear pumping, compatible contact materials, and controlled residence times are incorporated to limit contact activation and aggregation.

Virus Inactivation/Removal Method Development Service

Pathogen safety is embedded via solvent–detergent, pasteurization or dry-heat options, and nanofiltration cascades selected for the target's tolerance. We perform robustness studies (protein load, buffer composition, temperature excursions) and define worst-case conditions in scale-down models. Viral clearance claims are supported by validation-ready method packages (development reports, hold-time justifications, filter fouling studies) suitable for subsequent third-party clearance studies.

Potency & Cascade Bioassay Development Service

We develop and qualify potency assays aligned to pharmacopeial expectations and program needs: single-factor chromogenic/one-stage assays, global thrombin-generation readouts, and orthogonal clot-based kinetics where appropriate. For complexes (e.g., 4-factor PCC, aPCC), we build multiplex assay panels to quantify each component's activity alongside global function. System suitability, reference calibrators, and bridging strategies are defined to ensure continuity across method evolutions.

Advanced Characterization & Identity Confirmation Service

Comprehensive analytical packages establish identity, purity, and structural integrity. We combine intact mass and peptide mapping with targeted glycan profiling, multimer analysis (e.g., agarose/CE-based systems), SEC-MALS for aggregation state, AUC/DLS for hydrodynamics, and capillary electrophoresis for charge variants. We implement impurity and host matrix panels, residual reagents tracking, and activation markers (e.g., FIIa, FXa surrogates) with acceptance criteria anchored in stability and potency correlations.

Stability & Forced-Degradation Mapping Service

We design accelerated and stress studies to illuminate degradation pathways: thermal, freeze–thaw, agitation, light, and pH excursions. Kinetic modeling links critical quality attributes—potency, multimer distribution, aggregation, and activated species—to storage and handling conditions. Readouts feed back to formulation, process set-points, and packaging selections. We define stability-indicating methods, trending plans, and protocol templates for formal stability programs.