Perspective On: A Contract Lab

Contract labs perform scientific research and testing on one or more components of projects for external clients. Contracts can last anywhere from only a few weeks for a single, specific task to many years for extended projects. Taylor Technology Inc., a subsidiary of PharmaNet Development Group Inc., is a drug development contract research organization focused on bioanalysis, the measurement of potentially new chemicals or molecular entities (new treatments) in biological samples.

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Overcoming Technical Problems and Staying Current with Advances in the Field is Key

Contract labs perform scientific research and testing on one or more components of projects for external clients. Contracts can last anywhere from only a few weeks for a single, specific task to many years for extended projects. In every case, the ownership of the project resides with the client, and the work of the contract lab typically represents just one portion of the overall project.

Taylor Technology Inc., a subsidiary of PharmaNet Development Group Inc., is a drug development contract research organization focused on bioanalysis, the measurement of potentially new chemicals or molecular entities (new treatments) in biological samples. Based in Princeton, New Jersey, Taylor Technology works mainly for the pharmaceutical and biotechnology industries in North America, Europe, and Asia, and covers many facets of the work leading up to filing a New Drug Application for permission to market a new drug. That includes clinical stage research and work leading into pre-clinical stage research, such as animal testing.

Specifically, Taylor develops new analytical methods, performs the appropriate level of qualification or validation for each method, and then uses the method for analysis of our clients samples, says Richard M. LeLacheur, vice president at Taylor Technology.

We perform similar services for quantitation of biomarkers, endogenous substances that indicate through biochemical changes how a person is responding to a particular treatment. We can also conduct qualitative analysis, working to identify new, potentially unknown substances such as metabolites that may be present in the samples, he adds.

Traditionally, within larger pharmaceutical companies such work was done in house. However, there has been a shift in the industry as pharmaceutical organizations recognized that staffing for their peak needs was not cost effective. Therefore, they have been moving toward staffing only to needed capacity and contracting out some of the work.

Another reason pharmaceutical companies might outsource work is to utilize a specific expertise that their organization may not have. This is especially true for smaller pharmaceutical or biotechnology companies where a significant amount of early drug development work is performed. They generally have a much greater need to outsource because of lack of resources.

The majority of Taylors work is performed within a framework of regulatory compliance, or Good Laboratory Practice (GLP), required for later submission of results to regulatory bodies such as the U.S. Food and Drug Administration.

For drug discovery, early drug development, and some biomarker analysis, the regulatory framework may be reduced, LeLacheur explains.

Our work is performed using what are broadly described as immunochemistry techniques such as ELISA (Enzyme- Linked Immunosorbent Assay), or using mass spectrometry techniques such as LC-MS/MS and GC-MS/ MS. ELISA is a technique used with large molecules such as protein-based therapeutics to measure the presence of antibodies or antigens in a sample.

Lab structure

Taylor Technology employs about 130 people, 80 of whom are laboratory staff, working in a 55,000-squarefoot area. The remaining personnel work in quality assurance, data management, technical writing, and IT and computer systems support, and other departments.

The lab staff is divided into two primary operating groups: immunochemistry and mass spectrometry. Historically, this corresponded with analysis of large-molecule (protein, peptide) and small molecule therapeutics, respectively. This line recently has shifted significantly, and the mass spectrometry area now covers a range of both small- and large-molecule analyses.

Currently, four people report directly to me, LeLacheur says. These colleagues manage the mass spectrometry operations at Taylor, including both regulated and non-regulated analyses, and our data management/ technical writing team.

The mass spectrometry portion of Taylor has been in business for more than 15 years. On the immunochemistry side, weve been in business for only a few years, and the relative sizes reflect that, he explains. The mass spectrometry operation is still larger, while immunochemistry is growing much more rapidly.

The lab staff consists of chemists and biologists, and includes personnel from the pharmaceutical and biotechnology industries as well as veterans of other contract research organization (CRO) labs.

We have about 15 Ph.D.s on staff at Taylor, with backgrounds ranging from pure analytics to pharmacokinetics, explains LeLacheur, who holds a Ph.D. in environmental chemistry and has experience in environmental processes and analysis, including disinfection chemistry and determination of key pollutants.

We have about 15 Ph.D.s on staff at Taylor, with backgrounds ranging from pure analytics to pharmacokinetics, explains LeLacheur, who holds a Ph.D. in environmental chemistry and has experience in environmental processes and analysis, including disinfection chemistry and determination of key pollutants.

Well have people in the door before 7 a.m., well have people still here into the evening, LeLacheur says. So, while we dont formally define it as multiple shifts, we really encourage people to use hours that are appropriate to their project, appropriate to their deadline, and appropriate to the context of their own lives.

For early pharmaceutical discovery and development, the major effort is on the research and development phasethis includes method development in the lab and the appropriate qualification and validation subsequently required. The workload associated with early biomarker development is also focused on research and development.

Sample testing in early development takes relatively less effort and time. In later drug development, the situation is reversed, and large numbers of samples are typically analyzed, LeLacheur says. Overall, we expect to perform tens of thousands of analyses each month, and to qualify or validate dozens of methods.

Instrumentation

Bioanalysis requires significant sample handling. For this reason, LeLacheur’s lab utilizes more than a dozen robotic instruments, particularly for pipetting.

“We use fixed, 96-channel pipetting devices as well as more flexible systems to work with a variety of sample tube types,” he explains. “We generally find that semi-automated systems are most flexible and suit our needs; we have therefore avoided the expense and complexity of complete, unattended automation, but remain interested as new developments emerge.”

For final measurement and detection, the immunochemistry assays utilize a variety of spectrophotometric techniques, including absorbance, luminescence, electrochemiluminescence and fluorescence detectors from a variety of manufacturers.

The mass spectrometry group primarily relies on triple quadrupole instruments coupled with either gas chromatography or liquid chromatography.

“The mass spectrometry field continues to advance, and we are moving toward more high-resolution mass spectrometry (HRMS) systems—whether they are triple quad or true HRMS devices such as those based on Orbitrap technology—for improved specificity, sensitivity, and throughput,” LeLacheur says. “Similarly, we utilize and remain interested in developments of high-speed chromatography, including ultra high-performance liquid chromatography.”

Inventory, maintenance and hiring

When biological samples are received, a dedicated sample management team, whose job includes detailed inventory, notifies clients and team members of sample arrival and initiates electronic information tracking for each one.

“We utilize a specialized laboratory information management system developed and validated at Taylor specifically for management of a bioanalytical laboratory,” LeLacheur explains.

For maintaining lab supplies, Taylor utilizes a “just-in-time” principle— supplies are ordered as they start to be depleted—in order to minimize internal inventory without ever limiting operations. This strategy saves both space and money

“We both work directly with vendors and leverage our larger corporate relationships in obtaining and managing key supplies,” LeLacheur says.

Maintenance of laboratory equipment is primarily performed in house, even for the most complex analytical systems.

“We have an exceptional level of internal knowledge and experience, and draw upon talented personnel from IT, electrical engineering, and applications chemistry backgrounds to achieve and maintain the high performance required from sophisticated laboratory equipment such as triple quadrupole mass spectrometers and robotics,” LeLacheur explains.

Hiring is managed locally at Taylor, coordinated through an internal human resources staff. Relevant operations personnel conduct interviews with potential colleagues. For example, chemists will interview chemists and QA auditors will interview QA auditors. Taylor management uses this method to ensure that the current staff is deeply invested in selecting candidates and training their new colleagues.

Turnover is very low at Taylor. Even those who leave to go elsewhere have been known to return. LeLacheur happens to be one such employee: “I worked at Taylor in the 1990s and returned several years ago. The actual work and science may be similar to other laboratories, but the culture in this company is very supportive and very unique.”

Key challenges and solutions

The essence of the business at Taylor Technology may be more scientific and research-oriented than some of the more routine testing laboratories where the work tends to be similar each day. Therefore, LeLacheur and his staff are often faced with very difficult technical problems that can prevent the staff from making progress. During such times, morale can become an issue.

“Most experienced managers know how to keep their heads while all those around them might have a tendency to lose theirs,” LeLacheur says. “This helps bring in a little perspective and perhaps keeps everyone grounded.”

Those hard moments, LeLacheur notes, can also be used as teaching moments. “So it’s important to get people to realize that a research challenge is a learning opportunity that helps us grow, and ultimately it’s going to work to the benefit of our client to work through these problems.”

Having been through such experiences many times, LeLacheur encourages his staff to relax during difficult periods, work through problems, stay in very close contact with the client, and then ultimately see the project through to success.

“Success in bioanalysis, especially regulated bioanalysis, requires a focus on and mastery of details; success of the overall business makes me lift my head up from the daily details to make sure we check on where we’re going and how we’re getting there,” LeLacheur says. “My job presents me with the continual challenge of integrating the big and small pictures.”

In addition to helping his team technically, LeLacheur and the management team help boost morale at the workplace by organizing fun events during which the employees can enjoy the lighter side of Taylor Technology and PharmaNet.

“For example, we just had a large corporate-level picnic for families, with lots of entertainment and great food,” LeLacheur says, “and we have Pie Day later this week—Pie Day is just what it sounds like, we bring in a ton of really good pies from a local orchard/bakery, and just use it as an excuse to interrupt the day. We do it almost annually as a fall harvest kind of thing.”

In addition to a summer party and a holiday event, Taylor organizes other events aimed at improving techniques in the lab, facilitating internal communications, and raising the spirits of employees. For example, the lab is shut down about once a month for something called a training day, when everyone gets together for formal sessions about new standard operating procedures and informal sessions where the staff can discuss new developments within the industry.

“We have a big meeting with catered food to open the day, and we create very light-hearted moments. We update company news, and we give awards—typically called ABCDs (Above and Beyond the Call of Duty)—to people who have really risen to the task on behalf of a client through late nights, weekends, and so forth,” LeLacheur says.

Staying current

Because of the research and development aspect of Taylor, it’s imperative for the staff to stay current with advances in the field. For this reason, the management ensures that appropriate personnel attend relevant workshops and conferences covering both the scientific and regulatory aspects of bioanalysis.

“There are a number of conferences that we from Taylor attend regularly,” LeLacheur says. “This includes some of the big, industry-standard conferences such as the American Society for Mass Spectrometry, Biotechnology Industry Organization, and some of the smaller, more focused meetings.

“We try to get a lot of people out to conferences, not just management but also our technical leaders, our bench chemists, our QA auditors. We want to let people get out, hear what’s happening in the industry, and listen for new, emerging technologies,” Le- Lacheur explains.

Another way to stay ahead of the field is through clients, who themselves are also trying to stay current and find ways to improve.

“Collectively, between our experiences and their experiences, by drawing upon our combined expertise, we really start to see emerging technologies earlier,” LeLacheur says. “Everybody who is in touch with clients, everybody who is circulating at conferences, is bringing home information about what’s new.

“Maintaining the scientific and regulatory expertise of our staff is critical to the on-time delivery of the highest-quality results to our clients. We work daily to keep Taylor an exceptional place to work and to make the right investments for our staff and clients.”

Published In

The Next Level Magazine Issue Cover
The Next Level

Published: November 1, 2009

Cover Story

Movin' Up

With a good strategy and excellent execution, lab managers can take their careers to the next level, increasing their job satisfaction and fattening their wallets as well.