The staff at BioTechLogic has expertise in the purification processes – PEGylated and non-PEGylated proteins, antibody fragments, oligonucleotides and blood products. We have developed work processes, provided on-site manufacturing support and designed process steps using the following purification technology expertise:
- Laboratory and industrial-scale liquid chromatography
- High-pressure liquid chromatography
- Rotary evaporation
- Sterile filtration
BioTechLogic has experience in the design of unit operations. We provide knowledge and experience using various equipment and operating procedures, and consider validation requirements in the decision-making process.
BioTechLogic purification processes 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 solid support system validated and FDA approved for the first synthetically produced oligonucleotide
- NDA approval and MAA positive opinion of a Growth Hormone Receptor Antagonist
Purification Process Validation
BioTechLogic has expertise in managing all stages of process validation, including purification process validation, and proven experience in presenting the approach, the results, and the conclusions of a successful validation to global regulatory agencies.