Curated News
By: NewsRamp Editorial Staff
July 29, 2024
AGC Biologics Seattle Achieves Major Milestone for Regulatory Compliance in 2024
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- AGC Biologics Seattle achieves new commercial milestone for regulatory compliance, supporting multiple product inspections and approvals, gaining competitive advantage.
- AGC Biologics Seattle campus completed a new commercial milestone for regulatory compliance, supporting multiple product inspections and approvals, utilizing cGMP manufacturing lines and state-of-the-art processes.
- AGC Biologics Seattle's new commercial milestone for regulatory compliance helps bring life-saving treatments for bladder cancer and macular degeneration to market, improving patient care and quality of life.
- AGC Biologics Seattle campus achieves significant commercial milestone for regulatory compliance with FDA, supporting new treatments for bladder cancer and macular degeneration.
Impact - Why it Matters
This news matters because it showcases the commitment of AGC Biologics to quality and regulatory compliance, benefiting the pharmaceutical industry and patients seeking new treatments. The successful inspection and approval of new products demonstrate the company's ability to support partners in bringing products from clinical stages to commercial approval, ultimately improving access to innovative therapies.
Summary
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced a new commercial milestone for regulatory compliance in 2024 at its Seattle Campus. The site supported a multi-product inspection with the FDA, resulting in two approved products for commercial production at the facility. These products include a fusion protein-based drug for treating bladder cancer and a monoclonal antibody for treating macular degeneration. AGC Biologics Seattle predicts delivering multiple batches per year for the biopharma partners that received the approvals and accommodating increases in future demand.
Source Statement
This curated news summary relied on this press release disributed by News Direct. Read the source press release here, AGC Biologics Seattle Achieves Major Milestone for Regulatory Compliance in 2024
