Eurofins CDMO has the required expertise to support pDNA projects from early development stage until large-scale GMP plasmid production.
Strain and clone selection are critical steps in the pDNA manufacturing process as they can substantially influence the yield, quality and scalability of the final product.
Custom plasmids can be tailored to the specific requirements of a project. This includes selecting appropriate promotors, antibiotic resistance markers, codon optimisation, etc.
During strain selection, the choice of the host organism will be investigated to obtain the best results in terms of genetic stability, and the ability to support high-density cultures to enhance productivity.
Following the strain selection, a screening is performed to identify clones exhibiting the best plasmid stability, productivity and absence of undesired mutations. Upon selection of the best clone, a Research Cell Bank (RCB) will be produced. According to the specific project requirements, such RCB can also be the starting point for further banking activities, up to the manufacturing of a fully characterised, GMP grade, Master and Working Cell Bank (MCB, WCB).
In the process development phase, the aim is to create a robust, scalable, and economically viable process to deliver high quality plasmid DNA meeting to regulatory standards.
Using a parallel bioreactor system, fermentation conditions including growth media, temperature, pH, aeration and agitation can be optimised to maximise cell growth and pDNA yield. Downstream processing involves the purification and isolation of plasmid DNA from the cellular components and contaminants produced during the upstream fermentation process to meet the set quality requirements.
At every stage, critical process parameters will be identified and optimised to find the best balance between quality and yield. To this end, analytical methods will be employed to continuously monitor quality attributes during manufacturing.
As an economical alternative to GMP grade manufacturing, we developed an efficient plasmid DNA manufacturing platform that can be used to produce plasmid DNA within short timelines in a research-grade setting. The process is designed to meet the QbD principles and will allow a seamless transition of the project to GMP.
The process entails:
Deliverables:
Either starting from the materials provided by our customers, or starting from the materials generated with the previously describer development activities, Eurofins CDMO offers a comprehensive suite of services tailored for the production of plasmid DNA under strict GMP regulations.
E.coli cell banking services for master (MCB) and working (WCB) cell banks
Storage in temperature-controlled GMP warehouse
GMP grade plasmid production
Using complete single use process from USP until DSP
From mg to g scale
Qualified equipment in Grade C environment
Quality control for MCB, in-process testing, plasmid release and characterization
Incoming QC of raw materials
Assay qualification
Stability testing
QP release and full documentation
QA reviewed batch record documents
Certificate of conformity
TSE/BSE certificate
Certificate of analysis
