
ABOUT ANDELYN BIOSCIENCES
Andelyn is pioneering solutions that turn hope into reality as a biopharmaceutical CDMO. Capabilities span viral vector and vaccine process and analytical development, small to large scale adherent and suspension based GMP drug substance manufacturing up to 2000L, and finished drug product manufacturing services located in Columbus, OH USA.
Having 25+ years of experience with viral vector and vaccine manufacturing, Andelyn offers its clients direct access to globally recognized thought leaders with troubleshooting / characterization expertise and GMP material produced for over 75+ worldwide clinical trials. In addition to producing over 400+ cGMP clinical batches and 2000+ research grade productions, Andelyn currently provides research and tox grade plasmids with an additional offering of GMP plasmid manufacturing (early 2022), advanced quality systems, full regulatory support, semi-automated to automated fill stations, and supply chain vertical integration.
Its state-of-the-art 185,000 sq ft commercial manufacturing facility will expand capacity across 16+ production suites for customization of new programs and tech transferred programs as of July 2022, offering clinical through commercial-scale capabilities that will help accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients.
FEATURED ARTICLES
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When it comes to furthering AAV's potential in the wider biopharmaceutical pipeline, partnering with a CDMO that can foment an optimal analytical and manufacturing strategy is crucial.
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Unlike traditional drugs, AAV therapies require extensive characterization and testing, demanding varying degrees of analysis at each stage of development.
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AAV has become an increasingly popular vector for gene therapy applications, yet ongoing challenges related to process and analytical development often require significant expertise to navigate.
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Wade Macedone, Chief Operating Officer at Andelyn Biosciences, talks about how process improvement and operational excellence play an important role in the future of cell and gene therapies.
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Reliability issues continue to persist in GMP manufacturing for the cell and gene space. Learn how companies are focusing on reliability and predictability to further advance this innovative therapy.
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Securing the right plasmid for an application can be a complex endeavor. Core to this is selecting a supplier with the quality assurance protocols and GMPs to facilitate optimized plasmid production.
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To ensure that your adeno-associated virus (AAV) therapy reaches patients as soon as possible, begin your relationship with an experienced AAV manufacturer early in the development journey.
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Gene therapy is the process of replacing damaged or unhealthy genetic material with new material for treating diseases and conditions. Discover the manufacturing process including steps and timelines.
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The keys to success are establishing appropriate strategies and fundamental testing, expecting additional regulatory requests, preparing for assay variability, and ensuring comparability study preparation.
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Manufacturers with proven expertise in areas like viral vector production and analytics are needed now more than ever to get breakthrough, deliverable gene editing therapies to patients.
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Since the early 1990s, gene therapy has revolutionized medicine. In the coming years, it will continue to become more relevant in the treatment and cure of some of the most severe diseases and disorders.
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Due to its therapeutic impact on a wide range of diseases and disorders, adeno-associated virus (AAV) gene therapy is one of the most promising advances in modern medicine.
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Achieving optimized, scalable suspension processes for adeno-associated virus (AAV)-based therapeutics comes with a number of technical and business challenges.
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Viral vectors are essential for delivering corrected genetic information to faulty genes within affected cells and are at the heart of the gene therapy process.
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A clear path for establishing equivalency is needed to facilitate more rapid advances in the gene therapy field and ultimately to enable lower-cost gene therapies that reach patients faster than ever.
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Ensuring optimal yield for engineered viral vectors early in a process is crucial to ensuring their eventual commercial viability and broader patient accessibility.
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cGMP outlines safety procedures for every basic part of production – defining what needs to be done to keep products safe, operate machinery properly, validate processes, and maintain consistent procedures.
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A CDMO with in-house plasmid manufacturing capabilities can help companies accelerate timelines and ensure material availability, ultimately saving time and money throughout their product life cycle.
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Adaptability is crucial for developers as they upscale the production of viral vectors. Explore the benefits of using suspension cell lines and why adherent cell culture shouldn’t be left behind.
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Many challenges can stall an advanced therapy’s development. The vast majority of them are tied to inadequate preclinical planning and partner vetting.
CONTACT INFORMATION
Andelyn Biosciences
1180 Arthur E. Adams Drive
Columbus, OH 43221
UNITED STATES
Phone: (844) 228-2366