BioPharma’s World-Class Bioanalytical Laboratory: ‘Always Ready’ for the Next Project
An ‘Always Ready’ Approach is BioPharma’s key method for its Bioanalytical Laboratories
With its boutique bioanalytical laboratory, BioPharma specializes in small molecule bioanalysis with more than 200 biological assays for a variety of therapeutic products. The lab team of 25 staff members is overseen by Dr. Nicola Hughes, the Vice President of Bioanalytical Laboratory Operations for BioPharma Services.
The bioanalytical lab team consists of three groups who handle R&D, validation and production. They utilize LC-MS/MS analysis and possess nine SCIEX LC-MS instruments, four API 4000s and five QTRAP 5500 systems.
The scope of Bioanalysis and Bioanalytical Services offered at BioPharma include:
- Method feasibility
- Method development (GLP and non-GLP) and validation
- Method transfers
- Bioanalysis of biological samples from BE/BA studies and clinical PK studies
- Bioanalysis to support nonclinical toxicokinetic studies in all animal matrices
As with the rest of the BioPharma Services staff, Hughes and her team have high standards, not only for themselves but also for the studies they conduct on behalf of clients.
According to Hughes, “Our clients rely on us to deliver a high-quality product. That’s why we have repeat customers. Because many of them are driven at least partially by pricing and a tight timeline, we strive to keep our costs down but never compromise on quality. Also, when clients come to visit, they get the sense of the unity of our lab team and the trust between us.”
The BioPharma bioanalysis lab employees know their clients put a lot of emphasis and capital into their drug program, so those high standards they have ensured there aren’t any surprises when they go to run a study. They routinely achieve 98 percent passing batches and a method reproducibility of greater than 99 percent. Often, the studies they conduct reach 100 percent reproducibility.
“For every method we apply to a bioanalysis study to support a clinical trial, we have to demonstrate the reproducibility of that method,” notes Hughes. “My team understands my expectations and takes a lot of pride in their work. BioPharma is a package, and the lab is a very important part of it.”
Part of Hughes’ leadership is dealing with the ever-increasing number of annual validations. The 100 or so bioanalysis and clinical studies BioPharma works on each year are always on different drugs, and more than half of them require the development and validation of new methods along with the use of existing validation assays. A similar challenge is meeting changing regulatory requirements by bringing older methods up to current standards.
Making Teamwork a Priority
How do Hughes and the rest of the BioPharma staff routinely deliver an exceptional product to clients? Teamwork.
“More than anything, it’s the people, the team,” says Hughes. “We have a high level of scientific knowledge, from our junior bench-level chemist to our principal research scientists and up, and we invest in each employee. If one of our team members struggles, it’s very easy for that individual to get assistance from his or her co-workers.
“I’m regularly chatting with my staff to let them know they’re valued and encourage them to give me feedback if they see something that can be improved. Plus, our interdepartmental relationships are very strong.”
Not a lot gets by “Detective Hughes,” the affectionate nickname bestowed on her by her team thanks to her keen eye and ability to quickly solve problems.
“If something’s not quite right, I’m able to swiftly devise a solution, translate it to the team and get them working on corrective and preventive actions,” explains Hughes. “I also can step in if necessary to create a well-designed and written course of action to resolve any type of issue and then rely on my team to execute it.”
Hughes has been an integral part of the BioPharma team since 2016 and boasts more than 20 years of research experience and proven leadership skills. In addition to her love of science, she possesses a strong background in drug metabolism and clinical pharmacology, which enables her to expeditiously determine any pain points that might be an issue for a bioanalytical method and take them into consideration when developing it.
After procuring her Ph.D. in biochemistry, Hughes started out in a research and development (R&D) role and advanced up the career ladder to work in more senior positions. Renzo DiCarlo, CEO of BioPharma Services, reached out to her when he was looking to add some more scientific rigor to his bioanalytical laboratory team. She didn’t come alone, though.
“I actually brought in 10 individuals with me to BioPharma, including a skilled study director and R&D staff,” shares Hughes. “Along with the staff that was already in place, we formed what we call our ‘BioPharma Super Team.’”
What’s in the near future for the bioanalytical team at BioPharma? As Hughes reveals, “Last year, we had an exceptionally good year, and it looks like 2021 is turning out to be even better. We’re just always ready to take on the next project!”
BioPharma has built a full suite of clinical solutions from Phase I to BE/BA services to assist our clients’ clinical drug development programs. We invite you to come and experience the true BioPharma service: our people, our culture and our community. Contact us to learn more.
About BioPharma Services Inc.
BioPharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Bioanalytical Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Data Management and Medical Writing.
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