The choice of chromatography resins plays a significant role in reducing downstream costs. GMP contract manufacturer Avid Bioservices (www.avidbio.com) has been investigating anion exchange membrane adsorbers (from Pall or Sartorius) and hydroxyapatite resins to replace more expensive anion exchange chromatography in polishing operations. Hydroxyapatite is an old medium that is attracting attention these days because it operates in mixed mode (cation exchange and affinity, for example).
At the capture stage, Avid (and many other companies) are eager for alternatives to protein A affinity resins, which cost more than $10,000 per liter. Cation exchange, anion exchange, and hydroxyapatite can all be used to capture monoclonal antibodies provided the harvest is prepared for these columns, notes Richard Richieri, svp, manufacturing and bioprocess development at Avid, “But when you’re stuck you’re stuck—when you have to use protein A, you use it.”
Agility is becoming increasingly important in biomanufacturing, particularly for contract manufacturers, notes Eric Grund, Ph.D., director for Fast Trak Biopharma Services at GE Healthcare (www.gehealthcare.com). “They will need to start up manufacturing and switch products and scales depending on difficult-to-predict incoming demands.”
GE serves the need for agility through plug-and-play technologies like its ReadyToProcess™ disposable filters, available in either crossflow or normal flow. The benefits accrue, says Dr. Grund, not only from disposability, but from the ability to start up a new process or switch from one product to another “in a few hours rather than days,” and to serve a trend that he calls “capacity on demand.”
The idea, he says, can save on facility and infrastructure costs as well, as new processes can be built into simple, versatile, multipurpose facilities rather than dedicated plants.
Some GE purification products that serve the new paradigm of agility and on-demand processing include the Capto™ line of media, which is now well established and covers affinity chromatography (MabSelect, Capto Blue) and several ion exchangers (Capto Q, Capto S, Capti DEAE, Capto MMC, and Capto Adhere multimodal anion exchanger).
ReadyToProcess is a growing portfolio of plug-and-play solutions for bioprocessing that includes Wave bioreactors, depth and hollow-fiber crossflow filters, connecting devices, and flow paths. “The focus here is on genuine readiness for use, avoiding nonvalue-adding operations like wetting, rinsing, and cleaning as far as possible,” adds Dr. Grund.