FDF / DRUG PRODUCTS BIOLOGICS SERVICES in North America
Contract Development and Manufacturing Organization (CDMO) with a focus on recombinant proteins and monoclonal antibodies (mAbs).
About the plant
Axio BioPharma is an AI-driven biomanufacturing company revolutionizing how monoclonal antibodies are developed and produced. Headquartered in Madison, WI, Axio combines high-throughput production with proprietary machine learning to predict optimal scalable manufacturing processes in hours - not years.
By accelerating development timelines and reducing costs, Axio enables biopharma innovators to bring life-saving therapies to market faster and more efficiently. With deep expertise in antibody manufacturing, protein purification, and bioinformatics, Axio supports a wide range of partners across research, diagnostics, and therapeutics with scalable, U.S.-based production and data-enhanced process design.
Certifications
Activity
- Abs (Antibodies), Peptide, protein, hormone & enzyme, Vaccines, FDF / DRUG PRODUCTS, BIOLOGICS, SERVICES manufacturing
Features
- Uses: Investigational, Preclinical, Phase I, Phase II, Human, Veterinary
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
- DEA: N/A
- BSL: 1, 2
- Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V04) Diagnostic agents
- Markets: FDA (USA), EMA (EU)
Batch Size / Reactor
- Small, Medium, Large, Batch, Fed-batch, Perfusion, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L, 2000 - 5000 L
Services
- Development services, Manufacturing services, Analytical / QC services, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Downstream, Cell line development, Cell banking, Non sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of product, Bioanalysis, Analytical methods transfer
