From sequence design to GMP-grade plasmid DNA – an end-to-end CDMO partner for gene and cell therapy, mRNA platforms, and DNA vaccine programs.
Get a Free Plasmid Project EvaluationPlasmid DNA is a critical starting material for AAV/LV manufacturing, IVT mRNA production, DNA vaccines, and a broad range of gene and cell therapies, yet many programs stall due to low yields, poor supercoiled percentage, high endotoxin levels, or lack of GMP-ready documentation. Fragmented vendors and late-stage process changes can further delay IND/CTA filings and scale-up. Creative Biolabs offers an integrated plasmid CDMO platform that connects strain and strain bank establishment, plasmid process development, and comprehensive plasmid quality studies under a unified quality system, allowing you to engage exactly where you need support while keeping a clear path from research-grade material to cGMP plasmid DNA for clinical trials.
We address key plasmid manufacturing pains:
Three interconnected modules – strain & strain bank establishment, plasmid process development, and plasmid quality study – designed to support programs from discovery through clinical supply.
Clear, phase-gated milestones linking strain banks, process development, and quality studies into GMP-ready plasmid supply.
Discuss indication, plasmid use (AAV/LV, mRNA, DNA vaccine), required grade, scale, and timelines.
Select and optimize host strains, establish MCB/WCB, and secure a stable foundation for plasmid production.
Develop robust fermentation, lysis, and purification processes that are scalable to GMP.
Execute GMP batches with full analytical release, documentation, and regulatory support.
Plan re-supply, stability, and process improvements as your program advances through the clinic.
Clarify plasmid use, grade, and scale requirements; outline a phase-appropriate CMC plan.
Select and bank host strains that deliver high-yield, high-quality plasmid DNA.
Build and stress-test upstream and downstream processes ready for GMP transfer.
Produce clinical-grade plasmid DNA with full analytical release and documentation.
Support stability, comparability, and re-supply throughout clinical development.
| Stage | Services | Key Technologies & Readouts |
|---|---|---|
| Inquiry & Feasibility | Initial assessment of indication, plasmid type, target grade (research, preclinical, GMP), and required quantities. High-level risk, timeline, and regulatory strategy discussion. | Sequence liability review; backbone and selection marker assessment; preliminary CMC roadmap. |
| Strain & Strain Bank Establishment | Host strain selection, engineering if needed, and establishment of MCB/WCB to support robust plasmid production. | Strain screening; plasmid stability testing; bank characterization and documentation. |
| Plasmid Process Development | Optimization of fermentation, alkaline lysis, clarification, and downstream purification for yield and quality. | Fed-batch/high-cell-density fermentation; DoE/QbD; chromatography and TFF optimization; in-process controls. |
| GMP Manufacturing & QC Release | Execution of GMP plasmid runs with full analytical package and documentation for clinical use. | % supercoiled, impurity panels, endotoxin/bioburden; method qualification/validation; batch records, CoA/CoO. |
| Ongoing Supply & Lifecycle Management | Stability monitoring, comparability, and re-supply planning as programs move across phases and regions. | Stability studies (real-time/accelerated); comparability protocols; process improvement and tech transfer support. |
Phase-appropriate plasmid DNA for gene therapy, mRNA platforms, DNA vaccines, and genome editing applications.
Helper, packaging, and transfer plasmids that underpin robust viral vector production.
Templates and expression plasmids tailored for immunization and IVT workflows.
Plasmids for CRISPR/Cas systems, base/prime editors, and other editing tools.
Robust microbial hosts and scalable processes tuned for plasmid DNA production.
Fit-for-purpose plasmid grades and packaging options that evolve with your program from discovery to clinical stages.
Rapid, cost-effective plasmid lots for discovery, screening, and early proof-of-concept studies.
Enhanced control of impurities and documentation suitable for tox and GLP studies.
Plasmids manufactured under cGMP with full batch records, CoA/CoO, and regulatory support for clinical use.
Synchronized production and release of multi-plasmid sets for AAV, LV, and complex gene therapy platforms.
Flexible container types, fill volumes, and configurations to match your manufacturing workflows.
Buffer and stabilizer optimization, frozen and liquid formats, and stability programs tailored to your needs.
Our plasmid CDMO platform operates under a cGMP-aligned Quality Management System, embedding QbD principles, data integrity (ALCOA+), and phase-appropriate controls throughout development and manufacturing. Dedicated QA/QC teams oversee bank qualification, process validation, and analytical method lifecycle management.
Analytical packages are tailored to plasmid use and clinical phase, typically including identity and sequence confirmation, % supercoiled, residual RNA, host cell DNA and protein, endotoxin, bioburden/sterility, and topology characterization. We provide audit-ready documentation, support for IND/IMPD/CTA dossiers, and regulatory interactions as your program advances.
Biotech and pharma teams trust us to deliver consistent plasmid supply for AAV/LV, mRNA, and DNA vaccine programs.
“Our AAV program had struggled with low plasmid yield and inconsistent % supercoiled at another vendor. The Creative Biolabs team rebuilt the fermentation and lysis process, and within the first engineering run we exceeded our target yield with >90% supercoiled and endotoxin comfortably within our specs. That de-risked our entire CMC timeline.”
“We needed synchronized GMP plasmid lots for a 4-plasmid lentiviral package. Creative Biolabs coordinated strain banking, process development, and analytics such that all four plasmids were released together with aligned documentation. Our IND reviewers had no additional questions on the plasmid section.”
“Their plasmid quality study package was extremely comprehensive. The reports clearly laid out % supercoiled, impurity levels, and stability data in a way our internal QA and regulatory teams could immediately plug into the dossier. We felt confident relying on them as a long-term plasmid CDMO partner.”
Quick answers on plasmid grades, % supercoiled specifications, multi-plasmid packages, and timelines.
We typically offer research-grade, preclinical/GLP-supporting, and cGMP plasmid DNA. Each grade is differentiated by level of process control, impurity limits, documentation depth, and suitability for specific study types (discovery, tox, clinical). We can help map your current and future needs to the most appropriate grade.
We design processes to maximize the proportion of supercoiled plasmid DNA and can support target specifications aligned with your application and phase. During feasibility and process development, we discuss realistic % supercoiled ranges and how they link to downstream viral vector or IVT performance.
Yes. We routinely produce and release multi-plasmid sets for AAV and LV programs. Module-based scheduling helps align strain banks, process runs, and quality studies so that all required plasmids are released within the same time window, with harmonized documentation bundles.
We can start from your existing plasmid sequence and process or develop a new platform from scratch. For tech transfer, we review current batch records, analytics, and performance to define a practical transfer and optimization plan that maintains critical CQAs while improving robustness where needed.
Timelines vary with complexity and number of plasmids, but a phase-appropriate plan often includes strain and strain bank establishment, process development, engineering runs, and GMP production. We outline realistic, phase-gated timelines during the initial feasibility discussion and highlight options to parallelize workstreams where possible.
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