Plasmid DNA Process
Development and Manufacturing
End-to-end cGMP plasmid DNA manufacturing from preclinical quantities through to commercial gram-scale batches Purpose-built within a dedicated Nucleic Acid Suite, with an integrated same-site pathway from pDNA through to mRNA synthesis, LNP encapsulation and drug product manufacturing.
Plasmid DNA Manufacturing Platform
Our dedicated Grade C (ISO 7) cGMP environment, physically separated from protein manufacturing suites and purpose-built for plasmid DNA and mRNA manufacturing at clinical and commercial scale.
Plasmid Design and Construct Optimization
We take your sequence or existing construct and optimize it for plasmid copy number, structural stability, and regulatory suitability.
Cell Banking and Host Strain Development
Master and working cell banks established from your optimized E. coli strain, fully characterized and documented for IND, CTN, and commercial filings.
Upstream Fermentation and Process Development
High cell density fed-batch fermentation optimized for maximal plasmid copy number and biomass yield at every scale.
Downstream Purification and Release Testing
Continuous cell lysis, clarification, CIM monolith chromatography, TFF, and sterile filtration validated for supercoiled fraction homogeneity and injectable-grade purity, with in-house GMP release testing for faster batch disposition.
Plasmid Development and Manufacturing
High cell density E. coli fermentation optimized for plasmid copy number and biomass yield.
Plasmid DNA for Every Application
Gene Therapy Vector Production
AAV rep/cap and GOI plasmids. Lentiviral transfer vector, packaging, and envelope plasmids. Transposon-based non-viral gene delivery vectors.
mRNA Template Supply
Linearized pDNA template for in vitro transcription, with an integrated same-site pathway to mRNA synthesis and LNP encapsulation.
DNA Vaccines
Antigen-encoding plasmid vectors for infectious disease, oncology, and personalized cancer vaccine programs.
CRISPR and Gene Editing
Cas9, base editing, and prime editing plasmid delivery systems for CRISPR-based gene editing programs.
End-to-End Support for Your pDNA Program
Explore the development and manufacturing services that underpin every plasmid DNA program at BioCina.
Cell Line Development
01
Where Your Biology Meets Our Expertise.
We develop robust, well characterized cell lines that support reliable expression and long-term manufacturing consistency throughout your program.
Process Development
02
Processes Designed to Grow With Your Program.
From bench to commercial scale, we develop bioprocesses built for reproducibility, regulatory confidence, and the long-term success of your therapy.
Analytical Development
03
Analytical Methods Built Around Your Program.
We develop, optimize and validate the analytical methods your program needs, from early characterization through to regulatory submission, with rigor at every step.
Tech Transfer
04
A Seamless Transition From Your Facilities to Ours.
We manage every aspect of technology transfer with complete documentation, thorough risk assessment, and your team integrated at every critical milestone.
cGMP Manufacturing
05
Where Programs Become Medicines.
We deliver GMP-compliant manufacturing across drug substance and drug product with the precision, consistency, and regulatory credibility every program deserves.
Did you know manufacturing in Australia could fund nearly half your program?
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Drug Substance Manufacturing Track Record
0+ years
of cGMP manufacturing experience
0
Critical Observations
3
BLA Submissions
0+
products manufactured
Ready to Start Your pDNA Program?
Every plasmid DNA program starts with a conversation. Our team is ready to understand your requirements and find the right path forward.