BioTechLogic has experience managing pre-qualification and optimization studies for isolation 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