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Plasmid cGMP Manufacturing

PackGene provides GMP-grade plasmid manufacturing services for cloning, amplification, and purification of plasmid vectors to support subsequent GMP-grade AAV production as well as other applications. Our new segregated ISO-classified plasmid manufacturing suite (1000m²) is fully operational as of September 2021. We provide GMP-grade plasmid vector cloning, amplification and purification services and cover large-scale fermentation, material isolation, full traceability documentation control and comprehensive quality control assays.

Interested in our Plasmid One-Stop solution services?    Contact us for a free consultation or Request a quote.

Plasmid  Production Service

PackGene’s plasmid production allows for the use of existing plasmids provided by the customer, as well as the reconstitution of plasmids using PackGene’s proprietary vector backbone. We also provide complete upstream and downstream process development support for specific plasmid production.

Plasmid Manufacturing Facilities

PackGene’s cGMP fermentation scale ranges from 50L to 200L with single use fermentation units. GMP plasmids are wholly separated from other plasmids and plasmid-bearing materials by physical barriers to maintain separate and clean production conditions.

After each production batch is completed we clean and maintenance the entire facility room. This includes thoroughly cleaning surfaces and all non-disposable equipment prior to the start of the next GMP plasmid production run. In addition to this cleaning regimen, and we use disposable materials for most critical procedures to significantly reduce the chance of contamination.

GMP Plasmid Manufacturing Workflow

Plasmid Non-GMP Process

Plasmid cGMP Product Advantages:

  • Bacteria Bank Generation
  • Single-use fermentation (50L to 200L)
  • Ultra-filtration & AKTA ready purification system
  • Quality Inspection
  • Batch record, manufacturing summary report, CoA

Plasmid Quality Control (or customized based on specific process)

Category Items Method
General Characterization Appearance Visual inspection
pH pH meter
Identity Restriction Digest Agarose gel electrophoresis
Plasmid Sequence Sanger Sequencing
Content DNA Concentration UV spectrophotometry(A260)
Purity UV Purity A260/A280 ratio
DNA Homogeneity HPLC
Impurity Residual Host Cell DNA qPCR
Residual Host Cell RNA Agarose gel electrophoresis
Residual Host Cell Protein ELISA
Residual Kanamycin ELISA
Safety Endotoxin LAL
Sterility Test Direct Inoculation Method

PackGene’s Advantages:

  • Designed with Quality by Design (QbD) concept and optimization
  • Clean environment in accordance with C+A standards
  • Isolated vector production line to completely avoid cross-contamination
  • GMP-compliant pilot production cycle can as fast as 1-2 months
  • Single-use technology and water supply to ensure throurough cleaning between batches