Managers Need to Understand Existing Operational Capabilities and Requirements, Justify and Demonstrate Return on Investment, and Provide Detailed Implementation Plans

These days, laboratory operations are more visible than ever to management, whether they’re the organization’s shining star for profits or a capital expense black hole. If you are managing a lab and a budget, chances are you’ve gotten to know your organization’s purchasing and finance team—and they’ve gotten to know you—much better within the last year.

This increased visibility can be unnerving, especially for lab managers who have previously been more focused on the science than the business of the laboratory. Prepare for increased exposure and expectations of today’s management teams. Draw upon your experience and use the information at hand to confidently address budgetary, resource allocation, and other project management inquiries. Develop a strategy and a realistic implementation plan to enable your operations to meet or exceed your organization’s demands. Most important, deliver meaningful results. Position yourself so that your interactions across functions in the organization build your credentials rather than destroy your self-esteem.

Easier said than done. Begin by taking stock of your laboratory. Review your management’s expectations, factor in external influences that are out of your control, and determine how you’re going to deliver on your goals. Put yourself in a state of readiness so that you can recognize the short-term opportunities that will allow you to justify and drive a longer-term transformation of your laboratory into a strategic business asset—whether this means putting business systems in place to understand where to focus your efforts and assets or introducing forward-looking technology platforms to meet the needs of an ever-evolving business climate.

Get a clear picture of your current operations:
Assets and liabilities
Ongoing review of asset utilization and internal analytical process workflow is increasingly a way of life in the analytical laboratory. It’s necessary to plan strategic projects, justify capital requests, decommission assets, shift resources as necessary, and, in general, understand the facility’s operations.

Tools such as the Waters Empower™ 2 Business Intelligence Manager™ (BIM) provide a web-based dashboard software solution for rapid analysis of chromatography instrumentation performance data for faster, more qualified decisions on laboratory and business operations. Designed with proven business intelligence concepts that have been successful across many industries, the BIM allows lab managers and system administrators using Empower 2 Enterprise chromatography software to critically understand and exploit the strengths of their laboratories and identify areas that need added support.

As time passes, many laboratory technologies no longer provide a significant benefit to the laboratory—whether they are warehoused, sit unused on the lab bench, or consume more supplies and service time than is paid back in analytical impact. To determine the value of your facility’s technologies, take advantage of instrument vendors’ service and support organizations and asset management solutions. These services assist in evaluating where your technology is in its life cycle, so that you can intelligently decide when to decommission instruments or shift them to other departments where they’ll best achieve capacity utilization. If the technology no longer fits your organization’s needs, many times trade-in opportunities exist whereby you can get credit toward the purchase of a newer, more efficient or higher-capability model.

Embrace opportunities for change
The supply-side shortage of acetonitrile (ACN) has created an impetus for change in many laboratories. Even in facilities that are not directly impacted by this solvent shortage, the potential risk it poses to product supply and revenue generation is enough to catch the attention of senior management. With attention comes opportunity.

Savvy laboratory managers are leveraging the solvent shortage1 in conjunction with internal sustainability initiatives as a way to promote investment in technologies that not only minimize solvent consumption and disposal and their associated costs, but also improve laboratory productivity. Two technologies that have been cited by industry as tools that support greener laboratory operations are UltraPerformance LC® (UPLC®) and supercritical fluid chromatography (SFC).

By employing sub–2 μm particles, UPLC delivers more efficient chromatographic separations, enabling the instrument to use less solvent in shorter run times while maintaining or improving the performance achieved with traditional HPLC3 For example, the USP human insulin related-compounds assay consumes 20 mL of ACN per sample with a 68-minute run time by HPLC, whereas a UPLC separation of similar performance consumes 1.7 mL per sample with a 27-minute run time.4 This translates into a 92 percent decrease in acetonitrile consumption and a greater than 250 percent improvement in throughput. In a business environment where acetonitrile is being rationed and laboratory productivity is intensely monitored, this type of process improvement has been the basis of internal recognition awards for several of Waters’ customers by their own senior management teams.

Alternatively, using carbon dioxide as its primary solvent, SFC enables scientists to generate excellent chromatographic results, particularly for chiral and preparative separations. In a solvent-intensive application like preparative chromatography, SFC simultaneously reduces solvent costs and shortens drydown time for collected sample fractions.

Adopting alternative technologies is one approach a lab manager can take to address problematic external influences such as the solvent shortage. Adapting processes is another. With high-purity acetonitrile being prioritized for quality control, scientists in development laboratories find themselves in a position where methanol and other solvents are increasingly part of their method scouting and optimization protocols.

Where methods are being created or changed to use less acetonitrile, an opportunity is created for laboratory managers to modify existing method development and validation practices; for example, to make quality-by-design (QbD) part of the process. By introducing a design of experiment (DoE) approach into method development studies5,6,7, scientists can define a knowledge space where the impact of the chosen chromatographic parameters on separation performance is fully characterized. Once such a method is validated, operating within that design space provides chemists with a statistically defendable range of chromatographic parameters that can be used without having to invoke regulatory change control processes.

This regulatory flexibility can pay significant dividends downstream as methods are transferred to different laboratories and where unforeseen changes in materials and processes occur. In the past, DoE approaches were limited to individuals who had access to statisticians for appropriate study design and whose laboratories had the analytical capacity to run the relatively large sample sets required. Commercially available DoE software, such as FusionAE™ from S-Matrix® and the highly efficient, fast chromatographic separations provided by UPLC, now make the DoE approach tenable for more laboratories.

Build a strong platform for the future
Technology standardization has much to offer laboratory management: efficiencies in operator training, standard operating procedure (SOP) maintenance, service and support, purchasing decisions, and technology transfer. On the flip side, many scientists shudder at the thought of being confined to a predefined, standardized solution to their application challenge. Platform technologies introduce flexibility to standardization. Built from the core facets of the standardized technology, these platforms allow scientists to customize components to achieve specialized tasks.

Take, for example, UPLC. This liquid chromatography platform technology first manifested itself in the ACQUITY UPLC® system and its bridged ethylene hybrid (BEH) columns, launched in 2004 by Waters with the core functionality needed to support mainstream LC separations. Since its launch, the UPLC platform has expanded to include the nanoACQUITY UPLC® system, which adapts the hardware and columns to support sample-limited and two-dimensional applications such as those encountered in life science laboratories. For scientists exploring the use of chip-based technologies with mass spectrometry, the TRIZAIC™ UPLC® system with nanoTile™ technology brings simplified user interaction and increased consistency to nanoscale separations.

Further evolution of the UPLC platform is evident in its open architecture UPLC configuration and user interface that supports walk-up sample analysis and quantification. The platform even extends to the manufacturing floor, in the PATROL™ UPLC® process analyzer for online and atline analysis of production processes. UPLC also transcends typical vendor boundaries, with the ACQUITY UPLC and nanoACQUITY UPLC systems being controlled by many key suppliers’ chromatography and mass spectrometry (MS) software packages. This provides access to UPLC for scientists who have already standardized on a specific data management platform. In addition, expansion of UPLC column offerings and specialized application kits broadens the platform’s use to include separation of amino acids, peptides, oligonucleotides, aflatoxins, and perfluorinated compounds, to name a few.

The platform concept is not limited to chromatography. Due to the individual design of their ionization sources, switching among mass spectrometers can require different optimization settings, in particular the ionization and fragmentation parameters. With the Xevo™ MS platform from Waters, scientists can efficiently move between a tandem quadrupole and timeof- flight MS with the Xevo TQ and Xevo QTof, respectively, and expect the same ionization settings to transfer between the instruments. Moreover, tools such as IntelliStart™ automate system setup and optimization steps, removing the subjective influence of individual chemists and increasing the accessibility of these instruments to more analysts.

As organizations move toward lean operation, where any unnecessary step is stripped from a process, platform technologies are a natural fit. They provide a base level of consistency that facilitates servicing, training, and procurement while offering the versatility necessary to accomplish business-critical tasks.

Source smart and make your investments deliver
Today’s business environment is making everyone work and invest smarter. In the laboratory, this may mean stretching available capital by purchasing used instrumentation. Some original equipment manufacturers offer certified pre-owned instruments for sale at a significant discount. These systems are refurbished by certified technicians using ISO-documented processes. Whether you purchase new or used technology, once your capital is spent, the expectation is that you will demonstrate results. Whom you source the necessary equipment from is as strategic a decision as what equipment you buy.

The value of every technology investment is dependent on the implementation. How often is an instrument purchased and then not used to its full potential? Or worse, it sits idle on the lab bench—misused, misunderstood, or abandoned completely. Often this is the result of insufficient training, education, and application support services either at the time of purchase or throughout the technology’s lifetime in the laboratory. By not availing your laboratory of these services from the technology vendor, instruments can languish in an obscure corner of the laboratory, never fully achieving the promise of the technology or delivering the expected return on investment.

This is a period of simultaneous challenge and opportunity for lab managers. Laboratory transformation and investment are taking place, but not without a comprehensive understanding of existing operational capabilities and requirements, justification and demonstration of return on investment, and detailed implementation plans. Leverage today’s short-term business challenges as an opportunity to transform your laboratory into one of your organization’s greatest assets.

References:

1. “A Solvent Dries Up,” Alex Tullo. Chemical & Engineering News, 86(47), November 24, 2008.

2. Green Analytical Chemistry at Pfizer. Mark Harding. British Pharmaceutical Conference, September 2008.

3. ACQUITY UltraPerformance LC by Design. Waters System Technology Note, 720000880EN.

3. Transfer of the USP Human Insulin-Related Compounds HPLC Method to the ACQUITY UPLC System. Tanya Jenkins and Patricia McConville. Waters Application Note, 720001396, 2005.

5. “A Quality-by-Design Methodology for Rapid LC Method Development, Part I.” Ira Krull, Michael Swartz, Joseph Turpin, Patrick H. Lukulay, and Richard Verseput. LCGC North America, December 2008.

6. “A Quality-by-Design Methodology for Rapid LC Method Development, Part II.” Ira Krull, Michael Swartz, Joseph Turpin, Patrick H. Lukulay, and Richard Verseput. LCGC North America, January 2009.

7. “A Quality-by-Design Methodology for Rapid LC Method Development, Part III.” Michael Swartz, Ira Krull, Joseph Turpin, Patrick H. Lukulay, and Richard Verseput. LCGC North America, April 2009.