Company: ARWR
Filing Date: 2025-01-29
Form Type: ARS
Source: 0001628280-25-002866
Chunk: 57

Company: ARROWHEAD PHARMACEUTICALS, INC.
Filing Date: 2025-01-29
Form: ARS
Chunk 57
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 are located in Pasadena, California. The Company further recently expanded its footprint with a new manufacturing and laboratory facility to manufacture drug substance (API) under current Good Manufacturing Practices (GMP) in Verona, Wisconsin. Research and Development Facilities The Company operates research laboratory facilities in San Diego, California and Madison, Wisconsin, where its pre-clinical research and development activities, including the discovery and early development of RNAi therapeutics, take place. A summary is provided below: • State-of-the-art laboratories with supporting office space that comprise more than 251,000 total square feet; • Cell culture laboratories; • Complete animal facilities; • Animal efficacy models for numerous diseases, including cardio metabolic, viral, liver, skeletal muscle, ocular, central nervous system (CNS), metabolic, obesity and lung diseases; • Animal safety screening and assessment; • Clinical pathology laboratories and in-house histopathology capabilities; • Drug metabolism and pharmacokinetics (DMPK), bioanalytical, biodistribution, and clearance assessment and methodology capabilities; • Primate colony housed at the Wisconsin National Primate Research Center, an affiliate of the University of Wisconsin, and at other contract research organizations (CROs); • Pharmacodynamic method development and analysis and translational biomarker development capabilities; • Conventional and confocal microscopy, flow cytometry, Luminex platform, qRT-PCR and clinical chemistry analytics; and • Oligonucleotide, peptide, antibody, and small molecule discovery, synthesis, and analytics capabilities (for example, HPLC, NMR, and LCMS). GMP Manufacturing and Related Development Laboratory Facility The Company also recently expanded into a new, state-of-the-art GMP manufacturing facility in Verona, Wisconsin that includes related laboratories and office space to support chemistry, manufacturing, and controls (CMC) and quality activities. A summary is provided below: • State-of-the-art, custom-designed GMP oligonucleotide manufacturing facility with related support laboratories for process development and analytical development, comprising approximately 300,000 total square feet; • Full certificate of occupancy for laboratory, office & manufacturing spaces obtained August 2024; • Full analytical chemistry capabilities including method development and validation, transfer of methods, and support of in-process and final product analysis; • Drug product formulation development capabilities; • In-house capabilities to release GMP drug substance and finished drug product; • Multiple equipment scales for oligonucleotide manufacturing with maximum capacity to manufacture hundreds of kilograms of GMP drug substance annually; and • Drug substance manufacturing capabilities to