Synthesis, Fermentation and Cell Culture Processes
The staff at BioTechLogic has over 30 years experience managing and executing microbial fermentation, mammalian cell culture and oligonucleotide synthesis processes for the production of biopharmaceutical products. Our experience ranges from laboratory scale to production at large scale, including multiple expression systems and synthesis technologies. BioTechLogic accomplishments include:
- Multiple biopharmaceutical IND filings (cytokines, proteins, antibody fragments) at 10 L to 10,000 L scale
- Pre-Qualification activities for an antibody fragment produced at 10,000 L scale
- RNA oligonucleotide synthesis process performed on a solid support system validated and FDA-approved for the first synthetically produced oligonucleotide
- Oligonucleotide Synthesis validation at 100 to 300 mmol in manufacturing
- NDA approval and MAA positive opinion of a Growth Hormone Receptor Antagonist
BioTechLogic can design, develop and validate synthesis, fermentation and culture processes needed to produce biopharmaceutical products.
Synthesis, Fermentation and Cell Culture Process Validation
BioTechLogic has expertise in managing all stages of process validation, including synthesis, fermentation and cell culture process validation, and proven experience in presenting the approach, the results, and the conclusions of a successful validation to global regulatory agencies.