Northern Biomolecular Services
One-Stop Shop Biomolecular Analysis Services

Northern Biomolecular Services (NBS) is a contract research organization (CRO), specializing in advanced molecular biological techniques. Using real-time quantitative polymerase chain reaction (qPCR), reverse transcription qPCR (RT-qPCR), and digital PCR (dPCR) quantification, NBS provides a comprehensive solution for assay development, qualification, validation, and sample analysis. These methods adhere to FDA guidance and regulatory compliance while generating the highest quality data for their sponsors.

NBS supports the development of mRNA, gene, and cell therapy drug products by working with their sponsors to determine the biodistribution, persistence, gene expression, and elimination by analyzing samples collected from preclinical animal studies and vector shedding clinical trials. Ever since NBS’s launch in late 2019, the company has expanded its GLP-compliant facility at an incredible speed to meet the market’s needs.

NBS’s main objective is to effectively address and mitigate safety concerns, aiding the advancement of gene and cell therapy products. NBS has established robust methods to extract DNA and RNA from various tissues, biofluids, and vector shedding samples. (RT-)qPCR analyses are used to examine the extracted DNA and RNA and identify the presence and quantity of vector genomes and vector-derived gene expression, respectively. These analyses help assess the distribution and persistence of the therapeutic products within treated animal tissues. By analyzing vector genome presence, quantity, and gene expression patterns, NBS contributes to understanding the safety and effectiveness of mRNA, gene, and cell therapy products before advancing to clinical trials.

Safety consideration for gene therapy products involves potentially spreading the gene therapy product, such as recombinant adeno-associated virus (rAAV) vector, from dosed patients and animals into the environment. NBS analyzed feces, urine, saliva, semen, and/or other secreta samples collected from clinical trials and preclinical animal studies to detect the presence of vector DNA. This process provides critical data to support the development of these therapeutic products and ensure the safety of patients and the environment.

“Our strength is our team of experienced staff with extensive knowledge in developing and validating various cell and gene therapy testing methods to enhance sponsor therapeutics studies,” states Roy French, Director of Laboratory Science at NBS.

The company’s scientists, researchers, and lab technicians can also handle diverse samples and perform assays under various conditions while delivering high-quality data.

Notably, NBS’s Research Scientist, Kristin Bell, developed a dual purification approach for extraction of DNA and RNA from the same tissue lysate, which offers a great value to the gene therapy researchers. This trendsetting procedure enables close correlation between vector genome quantity and associated vector-derived gene expression within the same tissues, allowing cleaner and more accurate data processing while consuming less precious animal tissues.

Most laboratories today debate the use of traditional qPCR versus dPCR instrumentation for biodistribution and gene expression analysis in cell and gene therapy product studies. NBS has combined the two laboratory instruments and intertwined the best of qPCR and dPCR.

“We use dPCR for accurate determination of the concentrations of DNA/RNA standards, and then (RT )qPCR with the digital PCR-titer standards to help with a higher throughput sample analysis,” says Haiyan Ma, PhD, Director of Science at NBS. The strategy not only improves preclinical and clinical sample analysis accuracy, but also provides sponsors with the satisfaction of overcoming two obstacles—time limits and financial considerations.

NBS scientists have accumulated extensive experience in the gene therapy field since 2008. This knowledge plays a role in the overall study design when sponsors choose NBS as their CRO. For example, thoughtful consideration is taken during the design of primers and TaqMan probes to the target specific sequences within their test material. Scientists perform comprehensive research to ensure the developed primer/probe set is specific to the target sequence with specificity in not only the relevant study-specific species, but other animals including humans.

This approach empowers their sponsors to save time and quickly release pharmaceutical products. Since cost is a factor, the heightened operations allow sponsors to secure additional funding sooner. The commitment to supporting sponsors throughout the drug development journey—from the initial discovery phase to clinical trials—is yet another way NBS ensures a seamless and cost-efficient process.

NBS’s biomolecular analysis, data-driven techniques, and collaborative approach enable sponsors to identify efficient study design initiation and project outcomes. Sponsors can use the data to make well-informed decisions and confidently move toward the best result as NBS’ solutions portfolio is built on market research, customer feedback, industry expertise, and strategic planning. Its solutions are process-driven, with clearly defined objectives and a commitment to continual sponsor support.

The company offers unmatched expertise through a customized and sponsor-centric approach, proven results, comprehensive sponsor support, quality data, and a focus on building long-term partnerships. These factors collectively make the CRO an ideal choice for potential sponsors seeking a partner to help develop targeted treatments and cures for unmet medical needs. The efficient time management and fostering of a collaboration culture empower its sponsors to overcome time constraints by expediting scheduling and financial considerations through competitive pricing.

Through its team of industry-leading scientists, including experts such as Ma and Bell, NBS is on the cusp of expanding its services array by increasing its capacity and capabilities. The company remains dedicated to providing exceptional services to meet the growing need for its cell and gene therapy expertise. NBS has extended its services by offering to include protein sample analysis, utilizing enzyme-linked immunoassays (ELISA) and Meso Scale Discovery (MSD) assays. The company’s work culture directly influences the quality of its services and sponsor satisfaction, making it a reputable and sought-after partner in the biomolecular services industry.