Innovative Biotech Company Supports Cell and Gene Therapy Development with Plasmid DNA Manufacturing
Anemocyte offers plasmid DNA (pDNA) manufacturing covering R&D, High Quality and GMP needs providing solutions that support every stage of therapy development while ensuring rigorous quality and traceability.
With the rapid developments in advanced therapies, pDNA is critical in producing viral vectors, ex vivo cell therapies, in vivo gene therapies, and vaccines. Anemocyte’s comprehensive offering is designed to meet the unique needs of these therapies, with a focus on delivering pDNA at the right quality level for each phase of development, helping to optimize both cost and production timelines.
Tailored Plasmid DNA Grades for Every Stage
Anemocyte offers three distinct pDNA quality grades, each aligned with specific development and regulatory requirements:
- R&D Grade: Produced under ISO 9001:2015 standards in badge-controlled areas, R&D-grade pDNA is suitable for early-stage research and discovery. The production of R&D Grade pDNA focuses on speed and cost-efficiency, making it ideal for preclinical research.
- High-Quality (HQ) Grade: Designed for use in toxicology studies and early clinical stages, HQ-grade pDNA offers improved quality, with full traceability of raw materials and production in dedicated clean rooms following GMP guidelines. It includes comprehensive documentation such as Certificates of Analysis and TSE/BSE statements.
- GMP Grade: For advanced clinical and commercial applications, GMP-grade pDNA is produced under strict regulatory standards in segregated clean rooms. Each batch comes with full documentation for regulatory filings, including batch-specific audits and extensive quality controls such as microbial and particle monitoring during the filling process.
Flexible Manufacturing and Global Reach
Anemocyte’s facility spans 500 sqm of dedicated production and quality control space. This facility includes segregated clean rooms and areas designed for buffer preparation, upstream, downstream processing, and final filling, ensuring strict contamination control and compliance with GMP standards. Anemocyte’s strategic location allows easy access to international logistics, supported by three nearby airports, facilitating efficient global distribution.
Anemocyte offers flexible manufacturing capabilities, with batch sizes ranging from small-scale (1 mg) to large-scale multigram production, depending on client needs. The company also offers plasmid construct design services.
Commitment to Quality and Cross-Contamination Control
To ensure the highest levels of product purity and safety, Anemocyte employs strict cross-contamination controls. The facility uses single-use systems all along the production steps. Comprehensive in-process controls and regular environmental monitoring ensure that each batch meets rigorous quality standards.
Anemocyte’s testing services include restriction enzyme analysis, DNA sequencing, HPLC for homogeneity, and bacterial endotoxin testing. All processes are animal-origin free, with certified raw materials to ensure compliance with regulatory expectations regarding TSE/BSE.
The Importance of Supercoiled form of pDNA
At every quality level, the form of pDNA is crucial for its performance. Anemocyte focuses on optimizing the supercoiled form of pDNA, which is preferred for its higher transfection efficiency and greater stability compared to linear or relaxed forms. This structural integrity ensures better uptake by cells, particularly in therapeutic and clinical applications.
Conclusion
Anemocyte provides a full spectrum of plasmid DNA production services, from R&D-Grade to GMP-Grade, supporting each phase of therapy development. With a commitment to quality, flexibility, and sustanability, Anemocyte is a trusted partner for plasmid DNA manufacturing, ensuring the right quality level for each application. Whether for early-stage research or advanced clinical trials, Anemocyte’s tailored plasmid DNA solutions offer the scalability and regulatory compliance necessary to advance innovative therapies.
