Recombinant Coagulation Blood Factor Development

Within our integrated Pharmaceutical Development & Manufacturing framework, we specialize in Drug Substance Development for complex plasma-protein analogs, with a dedicated practice in Blood Factor Development. We deliver phase-appropriate, science-driven programs for recombinant coagulation blood factors, emphasizing robust processes, deep analytical characterization, and manufacturability-ready documentation.

Expression System & Cell Line Engineering Service

We design and generate high-performing CHO or HEK cell lines suitable for secreting complex coagulation factors, incorporating codon optimization, signal peptides, and selection strategies that favor product quality. When applicable, we co-express processing enzymes (e.g., furin) or accessory proteins to enhance maturation and secretion. Clonal screening includes high-throughput activity readouts and early quality fingerprints to ensure the line supports downstream specifications.

Upstream Process Development Service

We build chemically defined, scalable upstream processes tuned for quality attributes: feed strategy, dissolved gases, and shear management. For vitamin K–dependent factors, we configure vitamin K supplementation and recycling conditions that support efficient γ-carboxylation. We apply DoE-driven optimization to balance titer, specific activity, and critical quality attributes (CQAs), establishing scale-down models that predict performance at larger volumes.

Post-Translational Modification Control Service

We implement targeted controls for γ-carboxylation, glycosylation, sulfation, and proteolytic processing. Analytical feedback loops (e.g., Gla content profiling, glycan mapping) guide media additives, pH/CO2 strategies, and process intensification choices. For factor VIII programs, we address vWF-related stability considerations using tailored upstream tactics and downstream conditioning to maintain activity.

Analytical Method Development & Qualification Service

We establish a phase-appropriate, fit-for-purpose analytical toolbox: identity and purity (RP/SEC/HIC), host-cell impurities, residual DNA, intact/fragment mass, glycan and PTM profiling, and bioactivity (chromogenic and amidolytic assays, thrombin-generation kinetics). Method lifecycle management includes qualification, system suitability, and reference standard handling aligned to evolving specifications.

Stability & Forced-Degradation Study Service

We design accelerated, stress, and long-term stability protocols to reveal degradation pathways—oxidation, deamidation, fragmentation, and aggregation. Outputs inform formulation selection, primary-container compatibility, and allowable shipping conditions. We use orthogonal analytics to ensure degradants are well characterized and controlled.

CMC-Ready Documentation & Data Package Service

We compile development reports, risk assessments, control strategies, and method documentation suitable for inclusion in pharmaceutical development dossiers. Content is structured to articulate the process, CQAs, and supporting data.