Take Pains to Harvest and Clarify Painlessly

As biomanufacturers optimize cell cultures and bioreactors to improve yields and productivity, they are creating challenges downstream. With ever rising cell titers, harvesting the cells and purifying products becomes more intricate.

“Separation and purification of a biopharmaceutical may involve 15–20 processing steps. It’s complex and expensive,” notes Karen Albertson, global life science business director, 3M Separation and Purification Sciences.

3M’s goal is to make the separation process as straightforward as possible, starting upstream with harvesting and ending downstream with chromatography and sterilization. “When we stand back and look at the process, we’re focused on simplifying the whole train of events to improve speed, yields, and productivity,” Albertson says. “Each step you can remove automatically yields productivity improvements.” Likewise, optimizing the process even by 5% can be worth millions of dollars to a company.

Manufacturing is in 3M’s DNA

“We are a manufacturer, so we understand manufacturing. We know our products need to work not just in a manufacturing environment, but also in a lab environment,” Albertson points out. In addition to performing as intended, the products must be ergonomic, easy to use, safe, and trustworthy.

The 3M Zeta Plus™ encapsulated system for filtration is one example of how that understanding translates to products. Placed upstream of the 3M Emphaze™ AEX hybrid purifier, Zeta Plus filter capsules can be loaded horizontally at waist level in the Zeta Plus encapsulated system production holder, then pivot to a vertical orientation to save space and run multiple capsule columns in tandem, she explains. “We designed the system to be user-friendly, use space efficiently, and reduce waste,” Albertson says. The filtration system is designed for adsorptive depth filtration, cell culture clarification, and microbial reduction filtration.

“Our products are designed to work together to be more efficient, but we also recognize that everyone is doing something slightly different. So, if you have issues, call us,” she suggests. “We’re happy to have our application engineers optimize your platform with you.”

Strength through cross-fertilization

To succeed in the ever-changing and increasingly competitive biotech market, 3M’s biopharmaceutical purification business leverages the company’s fundamental strengths. “We’re a materials science company at our core,” Albertson declares. “Therefore, we have a lot of tools in our toolbox.”

3M’s strengths include:

• Technology platforms. “We have 46 platforms throughout the company that help us differentiate ourselves in the total market, beyond biopharma,” Albertson maintains.
• Manufacturing capabilities. “We manufacturer about 95% of our products ourselves and 100% of our biopharma products.”
• A global footprint. “We have R&D, manufacturing, and sales facilities throughout the world.”
• The 3M brand. “Our brand is personal for us,” she emphasizes. “For me, 3M means innovation, quality, and trustworthiness. The ability to help companies bring new drugs to market to improve lives is pretty powerful. That makes coming to work easy, because we know our work maters.”

The strength of the parent company enables the 3M Separation and Purification Sciences division to draw on capabilities and technologies from throughout the entire company to create new solutions. The Emphaze AEX hybrid purifier is one example. “We pulled core capabilities in nonwovens, surface modification, membranes, and our ligand library and introduced the resulting purifier a few years ago,” Albertson recalls. 3M literature describes the technology as “a novel anion exchange nonwoven media and a fine particle, reduction membrane.”

Because the Emphaze AEX hybrid purifier separates particles based on both charge and size, it can be applied to clarification and chromatography steps. It removes cell debris, DNA, and host cell proteins (HCPs) in aqueous solutions to boost separation efficiency and downstream productivity. In 2018, new capsules that extend the operating capability were introduced. Further expansions are likely.

A history of innovation

When university business programs discuss innovation, 116-year-old 3M inevitably is discussed. Long before “innovation” became a buzzword, 3M championed it. “All employees, regardless of their function or level within the company, are expected to innovate,” Albertson insists. Employees can devote 15% of their time away from their assigned tasks so that they may investigate new, better ways of doing things. (That culture resulted in—among other products—the Post-it^® note, which was revolutionary at the time.)

“We have a culture of picking up the phone or walking into somebody’s workspace to bounce ideas around,” she says, but there’s also a formal component. It includes 3M’s innovation centers, virtual communities, and technical forums, as well as structured gatherings that bring together experts from throughout the company to address formal challenges focused around solving specific problems. “It would just be wrong to get a phone call asking for insights and to not provide them,” relates Albertson. “It’s just expected.”

Biosciences: A new endeavor

This division is the outgrowth of 3M’s 2005 acquisition of CUNO, an expert in liquid filtration, and the 2015 addition of Membrana, a provider of membrane, ultrafiltration, and gas transfer in the life science, electronic, industrial, and specialty segments. “We really feel there are a lot of opportunities in purification, so forming this division plays to our fundamental strengths,” Albertson asserts. “This also helps us bring disruptive products to the market, which helps life sciences, environmental, and industrial clients become more successful.”

Integrating any company after it has been acquired is always a challenge, she admits, “but it’s satisfying to see the energy and passion in the division. The excitement in the business is infectious.”

3M Separation and Purification Sciences is becoming more well known in biotech. The division is young and is working closely with customers to discern their needs. “There are a lot of opportunities to grow,” Albertson notes.

Right now, “we’re known for our harvest and clarification products,” Albertson points out, “and it’s premature to discuss other upcoming products,” but the company is actively working with customers to identify their pain points. “People are very transparent about their challenges in dealing with the harvest from higher titers from bioreactors.” It’s logical, therefore, to expect 3M to develop solutions designed to improve yield and productivity in that area.

The 3M Separation and Purification Sciences division is involved in environmental and industrial endeavors, too. Those applications provide the division with myriad opportunities to explore and, given its culture of creativity, to innovate for bioprocessing.