Costs, Sustainability, Support, Supply
All the vendors interviewed for this article mentioned cost containment as a driver for new filter and integrated systems development. Nobody likes to spend more money than they have to, but for high-priced biologic drugs the degree to which cost of goods actually matters is unclear. On the other hand streamlining processes (to simplify operations and improve quality) is an undisputed need. That’s an area where vendors with strong materials and engineering expertise can make a difference. “We are constantly brainstorming with customers on how to leverage our materials science expertise to help from the perspective of cost and process simplification,” says Walker.
Several vendors provide calculations demonstrating that disposable purification equipment saves time and money in the long run. Replacing an anion-exchange resin step with a membrane eliminates resin/column preparation and cleaning time, and reduces buffer volumes significantly. Membranes are now available bearing cation exchange, HIC, and affinity chemistries as well. Yet, many bioprocessors do not appreciate the economics.
EMD Millipore’s take on the cost-of-goods issue is to produce filtration products that are more efficient, not necessarily less expensive. “Customers are looking for efficiencies, and as an industry we must provide them,” says Carroll.
Today’s biotech companies, he explains, carry very low inventories, conduct production campaigns under short lead times, and expect a vendor to deliver customized systems practically “just-in-time.” As expected, timely delivery and customization work at odds. Working with the growing number of overseas biotech companies and contract manufacturers adds yet two other factors, distance and divergent regulations, to the equation.
Top companies continue to address sustainability concerns with single-use process equipment. Carroll admits that on the surface it seems counter-intuitive to connect single-use plastic products with environmentalism. “However, considering capital and energy requirements of the building and operating facilities based on multi-use equipment reveals that single-use approaches can be much more sustainable.” EMD recently instituted a filter take-back program, through which it turns waste plastic into new products.
The biopharmaceutical business has become globalized, and this has created issues of supply and support, according to Nick Hutchinson, market development manager for pharma and biotech at Parker Hannifin. “We find that customers value rapid responsiveness to technical inquiries, but also support for filter selection, sizing, and trouble-shooting.” At the same time, lean manufacturing initiatives are creating awareness for holding inventories low.
Parker Hannifin specializes in PTFE (Teflon) membranes for gas filtration, PES for liquids, and polypropylene fibers for prefiltration. PTFE is highly hydrophobic, but Hutchinson notes that his company has rendered the material hydrophilic through a chemical modification that he could not disclose. He has “reason to believe, based on success in ophthalmic markets,” that this material could be adapted to bioprocess filtration as well.
“Globalization has special significance for biosimilars, where cost of goods is likely to be a stronger driver than for originator molecules.”