Hao Wang, Ph.D., Senior Director, BioanalysisThe challenges faced in bioanalysis are similar to those that impact the pharmaceutical industry as a whole. As a result, companies are increasingly drawn to the bioanalytical testing services market, searching for CROs and service providers that offer robust methods, rapid turnaround times, and protocols and procedures proven to deliver results that comply with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). Moreover, the increasing demand for supporting novel, specialized, disease-centric therapeutics has further boosted the need for a bioanalytical and ADME partner who can truly enhance the drug development process while providing the comprehensive data packages and expert guidance necessary to address stringent regulatory requirements. Outsourcing of bioanalytical services, particularly in the Asia-Pacific (APAC) region, is rapidly accelerating due to the emergence of many new small and mid-size pharmaceutical companies.
Amidst the increasing competition within the APAC region, particularly in the local China market, one company is known for innovative bioanalytical services – Q² Solutions. As a recognized leader with one of the world’s largest and most respected laboratory networks, Q2 Solutions offers global bioanalytical and ADME laboratory services across the product development continuum. Using advanced techniques, innovative solutions, customized deliverables and processes, and delivery excellence, Q2 Solutions supports many of the world’s largest pharmaceutical, specialty pharmaceutical, and biotechnology companies.
Q2 Solutions has emerged as a leading clinical trial laboratory service organization in APAC, empowering its clients with an extensive service offering that includes bioanalytical, genomics, vaccines, flow cytometry, anatomic pathology, companion diagnostics, and central laboratory services, including biospecimen and consent management solutions. Dr. Hao Wang, Senior Director of Bioanalysis at Q2 Solutions’ Beijing, China facility, is helping to tailor innovative solutions for customers by providing the high-quality, regulatory-compliant data that are required to drive informed decisions and regulatory filings. “At Q2 Solutions, our work is rooted in research, grounded in collaboration, and guided by our passion to turn the hope of patients and caregivers around the world into the help they need,” states Dr. Wang.
Drawing on 15 years of experience working with pharmaceutical companies and CROs, Dr. Wang notes that the frontiers of drug development are constantly changing, as new drug modalities raise the challenge for bioanalytical method development and validation. As such, bioanalytical scientists must understand an agent’s physical-chemical properties, its target, and MOA to develop a robust/reliable fit-for-purpose method. “In order to stay ahead of the competition in APAC, especially in the domestic China market, pharmaceutical companies require more comprehensive testing platforms. For instance, cell and gene therapies not only need traditional ELISA or MSD platforms, but also need flow cytometry and NGS platforms,” he adds. Q2 Solutions can serve as a reliable bioanalytical and ADME partner in this space, providing cost-effective solutions without compromising quality or delivery timelines.
Accelerating and Enhancing Discovery, Preclinical, and Clinical Programs
Q2 Solutions employs rigorous bioanalytical method development and validation strategies, statistical analyses, and scientific writing to ensure that all analytical methods are reliable, robust, and in compliance with regulatory requirements. rom in vitro ADME screening, discovery, and development for metabolite identification to DMPK services and regulatory validation, Q² Solutions enables its clients to seamlessly navigate their large-scale clinical studies. FQ2 Solutions is often approached by Chinese customers who wish to conduct global clinical trials and submit NDA applications in China, the US, and/or Europe but lack access to resources or testing services to facilitate the filings in the US or Europe.
At Q2 Solutions, our work is rooted in research, grounded in collaboration, and guided by our passion for turning the hope of patients and caregivers around the world into the help they need
Q² Solutions’ Beijing facility includes a state-of-the-art, custom-built expanded LC-MS/ MS laboratory with a growing instrumentation fleet that includes Sciex 5500 and 6500+ mass spectrometers. Large-molecule analysis services are conducted in a newly expanded laboratory that includes MSD SQ120 electrochemiluminescence plate readers, SpectraMax absorbance and multimode plate readers, PCR capabilities, an Ella multi-plex biomarker reader, and a BioTek Cytation 5. As part of its large-molecule services, Q2 Solutions also supports bioassays in a newly-constructed, dedicated cell laboratory. Although biomarker testing is often performed under CAP certification within the central laboratory services, Q² Solutions’ bioanalytical services also supports PK/safety studies under a GxP quality system for both small and large molecule therapeutics. Q² Solutions also provides services for vaccine studies that include ELISA and virus neutralization assays, with plans to install a CTL system for ELISPOT capability.
In addition, Q2 Solutions provides centralized lab testing, kit manufacturing, clinical sample management and logistics, project management services, database set-up, and procurement services. The company also specializes in specimen collection services in China, offering local kitting services in Beijing to facilitate collaboration between clinical sites and testing facilities and ensure that samples are delivered on time. “Our kitting facility serves the entire APAC region. Moreover, China-based kitting eliminates delays with customs and potential hurdles with importing kits. We offer a three-day average transit time for regular orders in China,” says Dr. Wang. When it comes to delivering biorepository services, Q2 Solutions leverages more than two decades of experience in centralized Sample Management & Storage (SMAS) capabilities in the US, UK, and China to provide clients with a global standard storage system.
Q² Solutions’ extensive scientific experience coupled with end-to-end laboratory solutions has made it an undisputable global leader in laboratory testing. “We serve many of the largest pharmaceutical, specialty pharmaceutical and biotechnology companies in North America, South America, Europe and Asia with scalable expertise and innovative solutions. We not only have the technology, systems, and processes to support your routine and complex projects, but we have more than 20 years of experience and industry leading knowledge to provide key insights into the development of your product,” notes Dr. Wang. In addition toits global footprint, prominent reputation, and unsurpassed history in the bioanalytical industry, Q2 Solutions is unique in that it harmonizes services between its r US and China-based laboratories. “We share the same SOPs, use the same model of instruments and data process to ensure any data generated in either lab will be reliable and comparable; this is needed for global studies in which samples are analyzed in different labs,” states Dr. Wang. “However, on the other hand, due to some differences between US FDA, EMA and China local regulatory agency (NMPA), we do make some changes to make sure studies conducted in China meet NMPA requirements.”
With bioanalytical, vaccine, central laboratory, and genomic services all available at a single location in Beijing, Q2 Solutions proudly offers clients a full-service, next-generation bioanalytical package.
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We not only have the technology, systems, and processes to support your routine and complex projects, but we have more than 20 years of experience and industry leading knowledge to provide key insights into the development of your product
Supporting Rapid and Reliable Biopharmaceutical Drug Development Efforts
With more than28 years of bioanalytical experience, Q² Solutions has supported hundreds of therapeutic programs, celebrating numerous successes along the way. Dr. Wang cites a recent success story involving a chimeric antigen receptor T cell (CAR-T) therapy. This particular agent was a first of its kind to be licensed in China and thus posed unique development challenges. . Although the assay for this agent was initially developed at a competing laboratory in the US, the client ultimately transferred the assay to Q² Solutions’ Beijing facility based on our long-standing reputation for scientific excellence and innovative solutions. Q² Solutions resolved logistical and technical challenges to enable a reliable bioanalytical method to support this drug program. “Our scientists were invested in optimizing the method using new reagents, and successfully established a new method to measure the anti-drug antibody. This CAR-T drug is now in the final stage to be approved by NMPA,” extols Dr. Wang.
On another occasion, Q² Solutions facilitated the registration process for a global pharmaceutical company’s approved drug. In this instance, the company unknowingly sought to register an approved agent in China without following Bioequivalence guidance recently issued by NMPA, thus resulting in a rejected application. The client reached out to Q² Solutions who in turn quickly helped to revise supplemental documentation per NMPA guidance and aided in resubmitting the application to the agency. Reflecting on this experience, Dr. Wang was pleased to note that,“[The application] passed without any issue the second time, and the drug was approved in 2020. The sponsor was extremely appreciative of the support and expertise provided by us.”
For a CRO with a strong value proposition, rich industry expertise, and unique capabilities in place, the future looks bright for Q2 Solutions. With the increasing demand for clinical trial laboratory services that include bioanalytical testing, Q2 Solutions is well positioned in the Chinese market. Q² Solutions continues to invest capital in its Beijing laboratory, including a recent investment focused around instrumentation and increasing the laboratory’s footprint, all of which will reap successes for its clients. The CRO looks forward to investing more than $1.8 million to purchase additional state-of-the-art equipment while also doubling the number of staff in 2021, enhancing its analytical capabilities and capacity for throughput.
Q2 Solutions has emerged as a bioanalytical services leader in China that can provide full service laboratory testing in one location, thereby reducing overall costs and ensuring timely execution of clinical trials. With the support of its strategic partners and customers, some of whom are the world’s largest biopharmaceutical companies, Q2 Solutions continues to provide comprehensive laboratory services to facilitate local and global studies. Dr. Wang summarizes Q2 Solutions’ commitment to provide comprehensive bioanalytical solutions by noting, “Whatever their needs, however complex the problem, we stand ready to partner with our biopharma clients to develop the solution. Our experience in supporting complex trials with cutting-edge laboratory solutions is exceptional, but most importantly, we are motivated by the work that needs to done – because it’s not just a clinical trial, it’s someone’s life. Every day, we are turning hope into help.”
