January 1, 2014 (Vol. 34, No. 1)

Gail Dutton

Malvern’s Development Process Is Driven by Small, Independent Entrepreneurial Division

Moore’s Law says, roughly, that processing power doubles every two years. While physicists say we’re pushing the limits of that law now, the point remains that scientific advances are increasing at an accelerating pace and that analytical instrument makers must be exceptionally nimble to keep up.

Fast-moving industries like biopharma face unprecedented analytical challenges that need immediate solutions. “The culture of innovation and agility have different requirements than volume manufacturing. Needs change at a tremendous pace. The trick is connecting what’s possible with what’s needed,” remarks E. Neil Lewis, Ph.D., CTO of Malvern Instruments. “We want to solve analytical bottlenecks, and you can’t do that through surveys when people don’t necessarily yet know what it is they want an instrument to do.”

The global Bioscience Development Initiative is Malvern’s approach to this frenetic pace of development. Malvern created an entrepreneurial division behind a firewall within the company. “This relatively small team of people looks at new and emerging unmet analytical needs and accesses and develops technology that meets those needs in short order,” Dr. Lewis says.

The team partners with senior executives in big pharma and small startups, as well as with academics and leaders in other industries. “Our engineers and scientists work with them as partners—not as customers—to bring their insights into our development process,” Dr. Lewis continues. “They discuss high level challenges, exchange ideas, gain early access to emerging technologies, and look at prototypes until an instrument is fit for purpose.”

The Malvern Instruments Viscosizer 200 system measures viscosity and performs molecular sizing analysis on sample formulations as small as a few microliters.

Partner Perspective

By absorbing input from its many contacts, Malvern broadens its own perspective, forming a more comprehensive view of the analytics landscape. In addition, communicating with outside experts stimulates action more readily than traditional, in-house deliberations.

“We could have done what we’re doing—developing advanced instruments—with a large engineering and manufacturing team. But with that approach, a lot of the capabilities bog down. Rapid development is not always well served in traditional models. ‘Agile’ methods can’t just be dropped in,” Dr. Lewis stresses.

In a sense, Malvern’s nimble approach is a return to the company’s early days. The company was founded in the late 1960s in the United Kingdom—“by a couple of guys who were working on particle measurement and characterization,” Dr. Lewis confides. Since then, the company has grown to become a major player in materials and biophysical characterization with a suite of technologies and an international presence. And now, anything but complacent, Malvern is counting on its development initiative to help it transform leading-edge innovations into commercialized products.

“With respect to the biopharmaceutical business, we focus on the preformulation and formulation part of the development process,” Dr. Lewis explains. “We work with companies that have promising new candidate molecules and provide them with new analytical tools that enable them to be turned into deliverable products. Many molecules start out with promising therapeutic properties, but have poor stability, can’t be formulated, or have other issues. Because this is a bottleneck for the industry, we attack that part of the workflow.”

The objective, Dr. Lewis says, “is not just answering the engineering ‘what’ and ‘how’ questions but—most importantly—the ‘why.’ Why is this particular analytical measurement important? What is the problem to be solved? Why do you need to know?” Once those questions are answered, the appropriate tool will become evident.

New Systems, New Horizons

The first product developed through the Bioscience Development Initiative was launched in the summer of 2013. Called the Viscosizer 200, it performs viscosity measurement and molecular sizing on sample formulations as small as a few microliters.

It features UV area imaging, and—unlike traditional microcapillary instruments—a dual-pass capillary system with two detection windows. Because size and viscosity analyses depend on time-based changes that occur between the two windows, this system eliminates errors associated with imprecise sample injection times. It was developed through a collaboration with a small British company.

A prototype instrument for protein structure analysis is also in development. “It measures whether the protein is in the monomeric state and stable, and whether it’s in the native folded state,” Dr. Lewis says. “This replaces the need for separate instruments to measure light scattering, calorimetry, and circular dichroism, making it particularly valuable for samples of limited quantities. All of the instruments we’re developing are applicable in our other business segments as well as in biosciences,” Dr. Lewis adds.

As Malvern has evolved from an instrument company focused on particle sizing to one now offering a broad portfolio of analytical solutions and a growing presence in the bioscience arena, collaborations and acquisitions have been a key part of Malvern’s plan.

Most recently, in September 2013, Malvern acquired NanoSight, a specialist in visualizing, measuring, and characterizing nanoparticles. NanoSight’s systems are closely aligned with Malvern’s Zetasizer family of instruments, so this acquisition extends Malvern’s solutions in the biosciences and for the characterization of other nanomaterials.

“This collaborative model aligned with a nimble product development team is a significant part of our strategy for growth into all of the markets we serve,” asserts Dr. Lewis.

Malvern Instruments

Location: Enigma Business Park, Grovewood Road, Malvern, Worcestershire WR14 1XZ, United Kingdom

Phone: +44 (0) 1684 892456

Website: www.malvern.com

Principal: Paul Walker, Managing Director

Number of Employees: 730

Focus: Malvern provides materials and biophysical characterization technology. Its Bioscience Development Initiative, based in Columbia, MD, focuses on biopharma’s formulation and development requirements.