AGC Biologics Strengthens Portfolio with Latest FDA Commercial Approval at Copenhagen Facility CDMO expands commercial track record for biosimilar manufacturing
Copenhagen, Denmark
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August 28, 2024 12:05 AM Mountain Daylight Time
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced the newest milestone at its Copenhagen Campus, a U.S. Food and Drug Administration (FDA) commercial approval for a biosimilar indicated for psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. This is the latest commercial biosimilar approval for the global CDMO, and a new milestone for its Copenhagen site.
The expiration of patents for biologics products is driving new players to enter the biosimilar market and offer lower-cost alternatives for patients. Market value for this drug segment is expected to be more than $126 billion by 2032, a 17.6 percent CAGR between 2023 and 2032, according to a 2023 report. AGC Biologics offers key resources for biosimilar developers, such as flexible and scalable single-use manufacturing technology, the ability to scale production based on market demand, and strong expertise in managing quality control requirements needed to advance in each clinical phase. All these characteristics led to AGC Biologics’ Copenhagen site guiding this new product to FDA commercial approval.
“We have one of the most extensive single-use technology bioreactor networks in the world. This allows us to start with the 2,000 L scale for product launch and scale out and utilize added vessels to reach larger batch sizes of 4,000 L, 6,000 L, 8,000 L etc. based on product demand in later phases. Through this economies-of-scale production model, we increase production for biosimilars as demand grows, while saving costs for our partners,” said Christoph Winterhalter, Chief Business Officer, AGC Biologics. “When you combine this element with our scientific quality expertise that emphasizes finding the Quality Target Product Profile (QTPP) – we are one of the best CDMOs available to help biosimilar developers meet clinical and commercial goals.”
“This latest FDA achievement at our site demonstrates why we have been so successful,” notes Andrea Porchia, General Manager, AGC Biologics Copenhagen. “I continue to be impressed by this site and our team’s commitment to quality, productivity, and helping partners achieve their goals. We look forward to helping to produce this important treatment and providing patients in need with a new option to choose from other than what has been historically available.”
The new commercial approval in the U.S. for this product comes after the AGC Biologics Copenhagen site announced the completion and opening of a new manufacturing building at its site in June, which more than doubled its single-use bioreactor capacity. The new 19,000 m2 ultramodern building offers a larger manufacturing floor, expanded quality control and process development lab space, and added utilities to support all operations at the site.
AGC Biologics’ Copenhagen site core teams of scientists have more than 25 years of expertise in biopharmaceutical development and manufacturing, including seven commercial products brought to market. The site offers pre-clinical through commercial production for protein biologics services using mammalian and microbial systems and has a gold EcoVadis Sustainability Rating for its environmental, health, and sustainability practices.
To learn more about AGC Biologics’ protein biologics manufacturing site in Copenhagen, visit https://www.agcbio.com/facilities/copenhagen . For more information on the company’s end-to-end global CDMO services in Europe, Japan, and the U.S. visit www.agcbio.com.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.
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