Plasmid DNA Manufacturing Services
In the rapidly evolving advanced therapies ecosystem, speed and reliability in plasmid DNA manufacturing is crucial. Our team leverages the established eXpDNA™ plasmid manufacturing platform and in-house testing to deliver both custom and off-the-shelf plasmid solutions to streamline your critical starting materials supply. With industry-leading timelines and a focus on quality, partner with our CDMO experts to streamline plasmid production and accelerate your cell and gene therapy programs with confidence.
Safeguard Your Starting Materials with Plasmid DNA CDMO Solutions
To cater to the diverse demands of cell and gene therapy development, we provide a comprehensive suite of plasmid DNA manufacturing services to support preclinical research studies to clinical development and commercial supply. You can provide an existing plasmid for production or rely on us to generate a custom plasmid tailored to your precise requirements. Additionally, our team offers end-to-end scientific support, encompassing both upstream and downstream process development for every plasmid DNA production program.
Quality is the cornerstone of our service offerings, ensuring the highest quality cell banks and final purified plasmid DNA, therefore minimizing risk of cross-contamination. With more than two decades of experience at our plasmid DNA CDMO center of excellence, our team has developed a robust plug-and-play toolbox screening approach for challenging plasmid types, fully single-use processing methods, and established comprehensive testing and release to meet current regulatory requirements.
Ready to discuss an upcoming plasmid DNA manufacturing program?
Universal Plasmid Manufacturing Platform to Streamline the Development Pathway
Focused on standardization, speed and product quality, the eXpDNA™ plasmid production platform supports your program strategy, streamlining development and expediting production timelines to as little as five weeks.
To drive successful outcomes in cell and gene therapy development, we harness advanced filtration techniques, RNAse- and animal-free components, and extensive expertise to ensure your plasmid DNA meets the highest industry standards.
Plasmid DNA Production Process
From Research to Commercial: Which Plasmid Grade Suits Your Program?
Plasmid DNA CDMO Center of Excellence | Keele, UK
Frequently Asked Questions (FAQs) About Plasmid DNA Manufacturing Services
High Quality (HQ) plasmids offer a phase-appropriate, intermediate grade solution, designed for toxicology studies and early-phase clinical trials, our HQ plasmid manufacturing process adopts the principles of GMP according to EMA guidance for plasmid starting materials.
GMP, or Good Manufacturing Practice, grade plasmids adhere to the strictest regulatory standards, making them suitable for late-phase clinical trials and commercial therapeutic applications. They undergo rigorous quality assurance processes to meet all regulatory requirements.
Custom-made plasmids, on the other hand, are designed and manufactured to a client's specifications. This allows for greater flexibility in terms of sequence, configuration, and other unique requirements, ensuring a perfect fit for the intended application. Both options maintain high-quality standards, but the choice between them often depends on the project's specific needs and timelines.
Tell us about your program. Whether you need human immune and stem cell products or CDMO services that include process development, clinical manufacturing, or preparing for commercial scale, we are here to support you. Send us a message describing what you need, and we’ll connect you with the right team.
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