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Plasmid DNA contract manufacturing
cGMP for clinical trials
FIT Biotech offers aseptic manufacturing of plasmid DNA using a characterized Cell Bank System. The company obtained a manufacturing license from the Finnish National Agency of Medicines at the end of year 2000. This attests to the high level of quality of our current GMP manufacturing area.
Aseptic manufacturing conditions are ensured by up-to-date design and monitoring of the clean room and the HVAC system, effective cleaning and maintenance program of the facility and the equipment, and by an environmental monitoring program. The processes and methods used are robust, well documented and validated.
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Batch scale 10 - 100 mg |
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Aseptic preparation and manufacturing
- Fermentation process in Class 10 000
- Purification and filling in Class 100
- QA/QC analyses of identity, homogeneity and impurity
- Additional analyses upon request
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Full documentation package for regulatory purposes is available upon request. |
Complete Master Batch Records are provided to the customer as a part of the contract manufacturing service.
Production for non-clinical use
FIT Biotech also offers GLP grade plasmid DNA manufacturing services.
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Plasmid production according to GLP |
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From small scale (10 - 100 mg) up to 1000 mg a batch |
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QA/QC analyses for identity, homogeneity and impurity |
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Additional analyses and full documentation package for regulatory purposes upon request |
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