From sequence to scalable biologics.
ArtProtein develops, scales, and characterizes complex biologics on our CHO-art and HEK-art expression platforms — from first stable clone through IND-ready documentation, for both human therapeutic and USDA 9CFR animal-health programs.
We support biologics programs across the full development lifecycle — from first stable clone to a regulatory-ready technical package.
Cell Line Development
Stable CHO/HEK cell lines engineered for multi-g/L productivity. Complete clone screening, productivity optimization, and monoclonality documentation for IND-ready programs.
Start a conversation →Process Development
DoE-driven upstream and downstream processes designed for reliable tech transfer. Scalable fed-batch, purification strategies, and robustness studies — built for regulatory filing.
Start a conversation →Analytical Development
Fit-for-purpose analytical methods and characterization packages aligned with regulatory expectations. Method development, product characterization, and comparability studies.
Start a conversation →Regulatory Documentation
CMC sections and supporting appendices for IND/IMPD submissions. Risk-based approach to qualification, development history reports, and pre-IND meeting support.
Start a conversation →A science-driven approach that takes your molecule from idea to IND-ready package.
Technical perspectives on biologics development from the ArtProtein team.
When selecting a production clone for your biologic, these five parameters determine whether you end up with a robust, scalable process or a development nightmare downstream.
Design of Experiments is not just a buzzword — it's the most efficient path to a robust, transferable upstream process. Here's how we apply it.
Preparing for your first IND submission? A practical checklist of the analytical data and documentation your CMC section will require.
Common questions from biotech teams evaluating a CDMO partner. For program-specific questions, start a conversation.
A biologics Contract Development and Manufacturing Organization develops and produces protein-based therapies on behalf of biotech and pharmaceutical companies. ArtProtein specializes in biologics expression across modalities — analyzing sequences and developability liabilities that affect expression, and designing processes purpose-built for each molecule.
Cell line development creates the stable producer cell line that will manufacture your biologic. The ArtProtein RapidClone workflow electroporates your construct into our CHO-art or HEK-art host, drives the population through kill-phase selection to recovery, and yields homogeneously expressing stable pools — typically within 3 weeks. Selected pools then undergo single-cell subcloning to identify the best-expressing clones, with monoclonality evidence and stability data delivered at 14–18 weeks total.
An IND-ready package documents everything regulators need to evaluate the manufactured product — from subclone identity confirmation through upstream and downstream process characterization, analytical method development, and any client-specific deliverables (stability, comparability, etc.). The package is structured to fit directly into your IND CMC section.
USDA 9CFR studies are required for biologics intended for veterinary or animal-health use — typically point-of-care products and anything regulated by the USDA Center for Veterinary Biologics (CVB-PEL). ArtProtein supports the full 9CFR pathway: study design and proposal drafting, the analytical testing itself, and the final report drafting for CVB-PEL submission.
CHO is the industry-standard host for large-scale biologics manufacturing — it scales well, has decades of regulatory precedent, and supports complex post-translational modifications. HEK is product-driven: certain molecules (some viral vectors, specific recombinant proteins requiring human-like glycosylation) express better in HEK. ArtProtein operates both — CHO-art for typical monoclonal antibodies and recombinant proteins, HEK-art when the molecule calls for it.
Whether you're at sequence stage or scaling an existing process, ArtProtein can help. Tell us about your program.