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GMP Plasmid

  • cGMP plasmid production up to 200L, with flexible scaling for any project size.
  • Strict contamination control by isolated production lines and advanced single-use technology.
  • 10+ years of expert plasmid manufacturing, with comprehensive process and technical support.
Plasmid.Preparation

  • Plasmids are crucial DNA tools for a wide range of therapeutic modalities, including gene and cell therapies (GCT), mRNA and DNA vaccines, and nucleic acid drug programs. As a leading CDMO for plasmid manufacturing, PackGene delivers a truly one-stop solution for GMP plasmid projects—supporting biopharma innovators from research to clinical development and commercial launch.

    Our GMP plasmid capabilities include:

    • Bacteria Banking: Secure, traceable master and working cell banks for consistent plasmid production.
    • Process Development & Optimization: Custom scalable workflows to deliver high-yield and high-purity plasmid DNA, suitable for regulatory submissions and clinical use.
    • Analytical Methodology Development: Comprehensive in-house QC testing for identity, purity, potency, residuals, and endotoxin—fully FDA/EMA/ICH compliant.
    • GMP Plasmid Manufacturing: Dedicated cleanroom suites for clinical-grade plasmid supply meeting strict regulatory standards.
    • Plasmid Stability Testing: Full stability study design and execution for batch release and long-term storage.
    • Document Preparation: Complete set of regulatory documents, batch records, and quality certificates for IND, CTA, and BLA submissions.

    With PackGene’s integrated GMP plasmid manufacturing services, you gain reliable, cost-effective GMP plasmid supply, technical expertise, and regulatory support tailored for gene therapy, cell therapy, vaccine development, and nucleic acid drugs.

GMP Plasmids Manufacturing
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Key Benefits

  • Productivity

    Two independent cGMP plasmid production lines support scalable plasmid DNA manufacturing up to 200L — ideal for both clinical trial supply and commercial programs.

  • Quality

    Isolated production suites, advanced cleaning procedures, and strict use of disposable materials ensure complete avoidance of cross-contamination, delivering consistently pure, regulatory-grade plasmids.

  • Flexibility

    Multiple plasmid production scales (pilot to large volume) and grades (research, NHP, GMP) allow tailored solutions to meet your project requirements efficiently and cost-effectively.

  • Expertise

    PackGene’s specialized plasmid manufacturing team brings over 10 years of experience in high-yield, clinical-grade plasmid DNA production, ensuring technical excellence and robust regulatory compliance.

  • Advanced equipment

    Industry-leading single-use technology is deployed in both upstream and downstream processing. All fill & finish operations are performed under VHP (Vaporized Hydrogen Peroxide) isolators for maximum safety and sterility.

Service Details

Service-Offerings

GMP Plasmid Manufacturing Facility

PackGene is a world-leading GMP plasmid manufacturer, with state-of-the-art facilities purpose-built for the highest standards of cGMP plasmid DNA production. Our 1,300 sq ft Process Development (PD) lab serves as the innovation hub for advanced R&D in plasmid process development, optimization, and scale-up.

Our impressive 11,000 sq ft GMP manufacturing suite is equipped with advanced fermenters ranging from 5L to 200L – enabling batch sizes, high-yield runs, and manufacturing of up to 100g per batch. With the capacity to produce more than 1,000g of GMP-grade plasmid DNA annually, PackGene is ready to meet the supply needs of the most ambitious clinical and commercial gene therapy, cell therapy, and vaccine projects.

Supporting this output is a dedicated, expert team of ~40 staff decades of combined experience in AAV plasmid preparation and GMP operations. We maintain seamless, uninterrupted production with 24/7 shift operations- ensuring the reliability, quality, and scalability our partners require

PackGene’s commitment is to deliver top-quality plasmids —produced, tested, and released under strict regulatory compliance— to advance cell and gene therapy research, clinical development, and commercial innovation.

lab

Performance

  • Scalability

    PackGene’s ongoing optimization of GMP plasmid production processes ensures exceptional scalability—delivering consistent , high-yield batch production for every project. Our advanced fermentation and purification workflows support seamless scale-up from research to clinical and commercial lots, driving reliable batch-to-batch yield and recovery rates for GMP plasmid DNA manufacturing.

    Service-Offerings

     

  • Batch-to-batch consistency

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Confidentiality Commitment from PackGene:

The information you submit here will be kept strictly confidential. Packgene will not disclose to any third party or related personnel, and it will only be used for project evaluation and progress reports according to the requests from submitter under confidentiality conditions.

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