GMP Plasmid Manufacturing
Driven by a comprehensive quality assurance process, Creative Biolabs produces GMP plasmids in isolated ISO classified manufacturing kits to ensure the highest quality products. Our experience comes from our expertise in DNA vaccines, gene therapy and immunotherapy solutions.
Creative Biolabs’s full GMP fermentation capacity ranges from 10 to 1,000 liters, which allows us to offer a full range of plasmid production services ranging from early research to commercial supply. The types of plasmids we produce include the viral vector (Retro, Adeno, AAV, HSV, VLP), and non-viral vector (DNA, RNA, EP, GGun, Lipo).
Our DNA program meets global manufacturing standards and is fully monitored by our Quality Assurance (QA) team. We are able to provide GMP compliance certificates and GMP activity summary reports as well as quality assurance audits of completed documents. In addition, we also provide cell banking and comprehensive GMP certification to support client projects...
GMP Plasmid Manufacturing Process
The manufacturing process involves screening for optimal growth, E. coli master and working cell bank, development and engineering, shaking flask or high density fermentation, alkaline lysis, chromatographic purification, quality monitoring and process control.
Plasmid Quality Control Assays
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Assays
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Methods
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Purity
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UV Spectrophotometry
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Bioburden
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Bacteria, spores and fungi
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Appearance
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Visual inspection
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Concentration
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UV Spectrophotometry
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DNA Homogeneity
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Densitometry analysis
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Endotoxin
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Kinetic turbidimetric LAL
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Identity
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EtBr-stained AGE
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Mycoplasma Contamination
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Quantitative PCR
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pH
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Potentiometric
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Assays
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Methods
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Plasmid Identity
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Double-stranded primer-walking sequencing
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Residual Host Genomic DNA
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Quantitative PCR
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Residual Host Protein
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Micro BCA
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Residual Host RNA
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SYBR gold-stained agarose gel electrophoresis
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Restriction Digest
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EtBr-stained AGE
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Sterility
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USP <71>
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Sterility Validation
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USP <71>
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Volume in Container
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USP <1>
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Particle Matter in Injections
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USP <788>
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For more details, please feel free to contact us for project quotations and more detailed information.
For Research Use Only | Not For Clinical Use
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