Isolation Processes & Separation Technologies
BioTechLogic has experience managing pre-qualification and optimization studies for isolation processes and separation technologies. We have managed laboratory scale processes and large-scale processes up to 30,000 L scale. Our experience includes the development and validation of the following:
- Precipitation
- Centrifugation
- Microfiltration
- Depth Filtration
- Cell Disruption (microfluidization, homogenization)
- Periplasmic Extraction
BioTechLogic accomplishments include:
- Pre-Qualification activities for an antibody fragment produced at 10,000 L scale
- RNA oligonucleotide synthesis process validated and FDA-approved for the second synthetically produced oligonucleotide
- NDA approval and MAA positive opinion of a Growth Hormone Receptor Antagonist
Isolation Processes Validation
BioTechLogic has expertise in managing all stages of process validation, including isolation process validation, and proven experience in presenting the approach, the results, and the conclusions of a successful validation to global regulatory agencies.
