Downstream Process Development
Purification
In any development program, the establishment of a high-yield, scalable, and cost-efficient purification process holds pivotal importance. Our team of scientists has successfully devised dependable, reproducible, and robust processes tailored for biologics. Utilizing an array of chromatographic techniques, we craft comprehensive purification sequences that span from initial harvest to final polishing stages. These methods are applied across diverse sources, including tissues/organs, cell paste, and conditioned media. At CuriRx, our guiding principle involves formulating processes that combine optimal efficiency and scalability, adhering to industry standards and approved methodologies.
We meticulously develop viral inactivation and clearance measures to ensure the safety and quality of the material intended for further processing into the drug product. These steps are designed to guarantee that the process yields safe and suitable materials for downstream processing.
Once a purification process is created, we delve into conducting robustness studies to ascertain acceptable process parameters. Additionally, our team focuses on the comprehensive characterization and profiling of impurities, enhancing our understanding of the process and serving as a reference point during scale-up endeavors.
Among our frequently employed chromatographic techniques are:
- Affinity Chromatography
- Ion-Exchange Chromatography – encompassing both cation exchange and anion exchange
- Gel Filtration / Size-Exclusion Chromatography
- Hydrophobic Interaction Chromatography
Other Services
- Resin screening
- Chromatography development and optimization
- Filtration (TFF and depth filters) development and sizing
- Bulk formulation development
- Viral clearance and inactivation steps development
- Downstream process Characterization
Selected major assets
- 1xAKTA pure: 0.001 – 25mL/min
- 1xAKTA Prime Plus: 0.1 – 50mL/min
- 1xAKTA Pilot: 0.1 – 800mL/min
- Centrifuge and depth filtration
- 4xUF/DF
