Monoclonal antibodies (mAbs) form an important therapeutic agent for the treatment of several diseases.[1] Recent technological efforts in the pharmaceutical industry have focused on increasing the versatility and efficiency of biomanufacturing systems for the production of mAbs. To do this, technological advances that enable quicker process times and more flexibility for a wide range of production situations, including lower batch sizes and multi-product facilities, are necessary. Downstream chromatography purification is a vital phase in the biomanufacturing process, and it is time and resource-expensive. Resin-based affinity chromatography technologies are widely used for the purification of desired products. However, they often need specialized equipment, lengthy setup periods, poor flow rates, and limited yield. For example, Protein A chromatography resins have long been used in the purification of monoclonal antibodies despite the associated limitations. While recent high-capacity Protein A resins have made great advances, there is still a need for alternate solutions to suit areas where improved efficiency and adaptability are required, particularly in terms of cycle time and handling.
Fiber-based protein A purification offers an alternative to these chromatographic resins. In conventional resins such as Protein A resins, mass transfer of target proteins is hindered by its diffusion. Diffusion within the porous structure leads to a flow-rate-limited operation, which offers a key hurdle to boosting purification productivity as increased contact time is required for better affinity. Instead, in the Fibre chromatography technology, fibre structure is very open to promoting mass transfer without diffusion, similar to membrane and monolith technologies, but it also generates a high surface area.[2] This is due to the additive process in manufacturing called electrospinning that uses electric force to draw charged threads of polymer solutions to narrow fibers with diameters in the order of a few hundred nanometers. [3] Fibre’s unusual properties enable it to achieve binding capacities of more than 30 mg/mL in seconds rather than minutes, as with standard resin-based chromatography. Because of the high flow rates and binding capabilities, it is possible to reduce process times and use quick cycling to reduce the amount of fibre adsorbent required. This allows for purifying cycles of roughly 5 minutes, rather than approximately 3 hours achieving about >35 fold increase in the speed of the process.[4, 5] When compared to resin-based chromatography, each of these approaches results in up to a 20-fold improvement in productivity. The fibro technique allows for the purification of up to 500 grams of mAb per litre of adsorbent per hour. In comparison, resin-based chromatography generally produces about 25 grams per litre per hour. Sartobind® nano, HiTrap Fibro™, and HiScreen Fibro™ are a few examples of fibre-based protein A purification technologies that can function at shorter residence durations, which decreases cycle times dramatically.
The membrane chromatography professionals from Cytiva, Sartorius, and many other users from the biopharmaceutical industry of India would be attending Biosimilar Workshop 2023 in Goa and if you wish to join, please visit www.biosimilarworkshop.com
Registration link:
https://bit.ly/Registration2023GOA
Visit Website:
For more information:
- https://www.cytivalifesciences.com/en/us/solutions/bioprocessing/products-and-solutions/downstream-bioprocessing/fibro-chromatography
- https://www.sartorius.com/en/products/process-chromatography/chromatography-consumables/chromatography-membranes/sartobind-rapid-a
Author: Mr. Ranjeet Desai (Research Scholar, Institute of Chemical Technology, Mumbai, India)
References:
1. Lyu X, Zhao Q, Hui J, et al (2022) The global landscape of approved antibody therapies. Antib Ther 5:233–257
2. Ghosh R (2002) Protein separation using membrane chromatography: opportunities and challenges. J Chromatogr A 952:13–27
3. Fu Q, Duan C, Yan Z, Si Y, Liu L, Yu J, Ding B (2018) Electrospun nanofibrous composite materials: a versatile platform for high-efficiency protein adsorption and separation. Compos Commun 8:92–100
4. Boi C, Dimartino S, Sarti GC (2008) Performance of a New Protein A Affinity Membrane for the Primary Recovery of Antibodies. Biotechnol Prog 24:640–647
5. Fibro mAb chromatography scaleup | Cytiva. https://www.cytivalifesciences.com/en/us/solutions/bioprocessing/knowledge-center/fibro-mab-chromatography-scaleup. Accessed 6 Dec 2022
