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CMC Expertise Accelerating Biologics Development for 20 Years and Counting

Working with my co-founders, colleagues, and clients on many fascinating projects over the last twenty years has been an honor. From the founding of the firm with former Pfizer colleagues until today, we have specialized in supporting the CMC and regulatory programs...

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.