CLINICAL SUPPLY MANUFACTURING ARTICLES
Luxturna Maker Spark Therapeutics' Flexible Platform Approach
The company proved the concept by bringing to market its AAV-based gene therapy for an inherited form of vision loss.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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Explore the unique capabilities at a Vancouver, Canada site for clinical-scale manufacture of lipid nanoparticles (LNPs).
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Examine how the next generation of therapies is disrupting supply chain logistics and explore solutions for the complexities within cell and gene therapies.
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While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.
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While cell and gene therapies are bringing new hope to patients experiencing rare and serious diseases, uncover how they're disrupting the biopharma market in new and challenging ways.
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An inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases.
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As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.
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Adopt an integrated development strategy to streamline the path from early development to the clinic, ensuring timely clinical supply while reducing delays, risk, and inefficiencies.