Program & CMC strategy
End-to-end review of your program, identification of technical and CMC risks, and development roadmaps aligned to your funding, resources, and partnering plans.
Services
ArtProtein provides two complementary sets of services for antibody and recombinant protein programs in CHO and HEK:
- Advisory & design services – strategic, technical, and regulatory support.
- Laboratory & development services – non-GMP execution for biologics programs.
All services are delivered by professionals with more than 20 years of experience in biologics development, CMC, and regulatory work, including USDA 9CFR–related studies.
Advisory & design services
Cell line & expression strategy
CHO vs HEK platform recommendations, with stable and transient expression strategies tailored to speed, risk, and long-term supply needs for mAbs and recombinant proteins.
Upstream & downstream concepts
Fed-batch, media/feed, and purification concepts that anticipate later scale-up, critical process parameters, and manufacturability requirements.
Experimental & DoE planning
Study designs for transient and stable expression, upstream optimization in scale-down models and process-controlled bioreactors, and purification screening and robustness work.
CMC & regulatory support
Technical content for CMC sections, development summaries, and USDA 9CFR proposals, study plans, and final reports that clearly explain what was done and why.
Laboratory & development services
Non-GMP laboratory services designed to generate practical data and material that can be carried into GMP manufacturing and regulatory submissions.
Stable & transient CHO/HEK expression
Transient expression in CHO and HEK for fast-turnaround material to support feasibility, assay setup, and early screening, and stable cell line development for longer-term supply and tech transfer.
Upstream development & scale-up
Process development in scale-down models (deep-well plates, shake flasks, small bioreactors) with translation into process-controlled bioreactors at bench and larger scales, using DoE-driven optimization.
Purification & early analytics
Lab-scale purification schemes and basic analytical panels (titer, purity, aggregation and key attributes) structured so results can be reused in CMC and tech-transfer documentation.
Tech transfer support
Process descriptions, control strategies, and development reports prepared for GMP partners, plus structured handover packages and support during engineering runs as needed.