Plasmid DNA Manufacturing Services
Andelyn Biosciences has more than 20 years of experience in cell and gene therapy manufacturing. We possess the capability and capacity to manufacture batches of plasmids in any size depending on client specifications – from small trials to clinical-scale plasmid production.
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In all of our manufacturing, we emphasize GMP compliance, and follow best practices for upstream production and downstream purification development, as well as material segregation, large-scale fermentation, and much more.
All products are created with full traceability and document control to ensure they meet customer specifications – and with rigorous quality control testing, we ensure our customers only get high-grade plasmids that will meet their specific needs.
At Andelyn Biosciences, our stellar track record, end-to-end approach cGMP plasmid development and manufacturing, and dedication to product quality and reliability make us the best choice for production.
From small test batches to large-scale, plasmid DNA manufacturing, we can handle projects of all sizes, complexities, and requirements. To learn more and get started, contact us online to speak to one of our experts and discuss your unique needs in further detail.
Plasmid Production CoreOur Plasmid Production Core uses state-of-the-art tools and technology that allows you to rapidly scale plasmid manufacturing, providing you with shorter overall lead times and more flexibility in manufacturing timelines. We can accommodate changes in schedule and scale easily, ensuring your project goes off without a hitch.
The production facility comprises of laboratory space reserved for plasmid manufacturing for research grade productions and for IND-enabling toxicology productions along with AAV vector cloning capabilities.
Production scales can range from small scale 5-25mg preps up to large scale 100-500mg preps. Scales are determined by the amount of bacteria (liters) grown. For large-scale preps, the amount is determined in increments of 12L.
Critical materials used for Plasmid Production Core are single-use, disposable and are defined and specified prior to production. Materials used conform to USP/NF guidelines where appropriate. All materials used are recorded in solution preparation forms or on plasmid batch records.
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