GMP-Grade Plasmid DNA Manufacturing

LakePharma offers plasmid DNA cell line development, master cell bank manufacturing, and two grades of GMP plasmid DNA manufacturing at its microBiomanufacturing™ Center in Hopkinton, MA, conveniently located within close proximity to the Boston biotech hub.

LakePharma designs productive and efficient processes to manufacturing plasmid DNA in the cGMP facility. Plasmid DNA can be produced in batch sizes of milligram to multi-gram scale. Single-use technologies are also utilized to reduce potential cross-contamination issues. Together with vector construction services, LakePharma offers fully integrated solutions from vector design to manufacturing of non-GMP plasmid and fully compliant GMP-grade plasmid DNA. 
 

Integrated Vector Design & Manufacturing Services from LakePharma 

 

 

Key Highlights
 

Two GMP grades of plasmid DNA to meet your needs
Experienced, customer-focused teams to support your project
Single-use technologies to reduce potential cross-contaminations
Integrated platform technologies to deliver best-in-class materials for your drug development needs


Comparison of GMP Plasmid DNA Manufacturing Services 

  GMP-Standard GMP-Plus
Consistent manufacturing process:
    - Approved batch record
    - Standardized in-process control tests
    - Chromatographic purification
Quality oversight:
    - Raw material traceability
    - Manufacturing summary report
    - Certificate of Analysis
ISO cleanroom manufacturing
Single-use equipment and materials
Development work and engineering run prior to GMP production  
Specific process control and analytical method development  
Client-approved change control  
Formulate to client-specific concentration  
Client-specific Master Batch Records  

 

Cat.# Service Name Timeline Size Price Quantity Request
Custom Plasmid DNA GMP Manufacturing Standard TBD 1 Request
Custom Plasmid DNA GMP Manufacturing Plus TBD 1 Request

A typical project can consist of the following steps:

 

1. GMP cell line development or Master (Working) Cell Bank generation

2. GMP-grade plasmid DNA production

3. GMP plasmid DNA testing

 

For more information, please contact our specialist Matt Delaney at matt.delaney@lakepharma.com

Materials/information LakePharma needs at the start of the project:

 

1. Information on plasmid DNA and bacterial strains

2. Information on antibiotic resistance of the plasmid

3. Information on sequence or sequencing reference

 

For more information, please contact our specialist Matt Delaney at matt.delaney@lakepharma.com

Testing or Requirement Specification
Formulation Formulated in TE (Multi-compendial 10 mM Tris, 1.0 mM EDTA pH 8.0) and sterile filtered (0.2 µm) or per client request, stored/shipped frozen
Required Aliquots and Quantities Per client specification
Visual Appearance Clear, colorless and free of visible particles
Plasmid Identification (e.g. sequencing) Identical to reference sequence
Sterility (USP <71> Bacteriostasis/Fungistasis) No growth
Purity (260/280 ratio) 1.80 - 2.00
Concentration (UV spectrophotometry) 1.0 mg/mL ± 10% or per client request
DNA Homogeneity (densitometry of EtBr-stained agarose gel) > 80% supercoiled
Osmolality Report
pH Report
Identification (e.g. gel electrophoresis) Co-migrates with reference DNA or size confirmed against supercoiled markers
Mycoplasma (qPCR) Negative
Endotoxin (Kinetic LAL) <20 EU/mL
Residual Host Genomic DNA (qPCR) ≤ 5%
Residual Host Protein (Micro BCA) ≤ 1%
Residual Host RNA (SYBR Gold agarose gel electrophoresis, densitometry) ≤ 5%
Restriction Digest (EtBr-stained agarose gel) Matches reference pattern