2026-10-13T05:46:17Z https://api.figshare.com/v2/oai

oai:figshare.com:article/33981499 2026-09-24T10:56:58Z category_140 portal_316 item_type_3 month_year_09_2026

Supplementary file 1_Further optimization of an ADMA Biologic's proprietary manufacturing process to ensure removal of impurities associated with thrombosis risk in IVIG products.docx Kaitlin Kestenberg (25103548) Laura Holler (25103551) Paul O’Grady (25103554) Rebecca Avila (25103557) Miranda Capra (25103560) Adam Grossman (2374111) Cardiology Factor XIa immunoglobulin primary immunodeficiency safety thrombosis <p>Thromboembolic events (TEEs) are a rare, but serious adverse event for patients receiving immunoglobulin therapy. Patient and product-specific risk factors can increase the risk for these adverse events. To reduce this risk, ADMA has further optimized the manufacturing process of intravenous immunoglobulin (IVIG) products to remove impurities that may precipitate these events. Key attributes were tested in three lots of ADMA's IVIG products from the further optimized process. Across the three lots analyzed, quantification values for each parameter tested were at or below the limit. Since the commercial release of ADMA's IVIG products produced using the further optimized manufacturing process, ADMA's post-marketing pharmacovigilance surveillance and the FDA Adverse Event Reporting System has received zero reported cases of TEEs from July 1, 2025 to July 31, 2026. ADMA's further optimized manufacturing process ensures removal of impurities while also ensuring high recovery of immunoglobulin from source material.</p> 2026-09-24T10:56:58Z Dataset Dataset 10.3389/fcvm.2026.1874074.s001 https://figshare.com/articles/dataset/Supplementary_file_1_Further_optimization_of_an_ADMA_Biologic_s_proprietary_manufacturing_process_to_ensure_removal_of_impurities_associated_with_thrombosis_risk_in_IVIG_products_docx/33981499 CC BY 4.0