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 Hopkinton, MA facility, 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. The facility is ISO 13485:2016 certified.
 

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


LakePharma provides two grades of plasmid DNA 

  GMP-Ready
(10 - 500 mg/batch)
GMP
(100 - 500 mg/batch)
Process Development: Transformation Assessment and Evaluation  
ISO Cleanroom Manufacturing
Single-Use Equipment and Materials
(Aseptic Connections)
Approved Batch Record
Standardized In-Process Control Tests  
Chromatographic Purification
Raw Materials Release
Manufacturing Summary Report  
Certificate of Analysis
(Full Panel Release Testing)
Client-Approved Change Control  

 

Additional Services Available Upon Request:

  • - Development work and engineering run prior to GMP production
  • - Specific process control and analytical method development
  • - Formulate to client-specific concentration
  • - Client-specific Master Batch Records

 

LakePharma also offers GMP biorepository services. Click here to learn more. 

Cat.# Service Name Timeline Size Price Quantity Request
Custom "GMP-Ready" Grade Plasmid DNA Manufacturing Service TBD 1 Request
Custom "GMP" Grade Plasmid DNA Manufacturing Service 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 inquiries@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 inquiries@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