In the ever-changing world of pharmaceutical research and development, the search for novel therapeutics hinges on the efficient utilization of biological samples. Without good quality samples with maintained integrity, there can be no accurate or reproducible data to be scrutinized by governing bodies such as the Food and Drug administration (FDA). As a leading provider of biobanking services that offers a comprehensive suite of solutions tailored to the diverse needs of researchers, Sampled’s Global Integrated Analytical Biorepository (GIAB) is poised to help researchers store their precious samples appropriately.
In this article we will look at how safe and correct storage of samples is crucial from the nascent stages of drug discovery to post-market surveillance and how Sampled’s biorepository services can play a pivotal role in advancing medical breakthroughs.
1. Role of biobanking in early Research and Development:
In the initial stages of drug discovery, researchers must rely on access to high-quality biological specimens to unravel the underlying mechanisms of diseases and identify potential therapeutic targets. Sampled’s biobanking infrastructure serves as a vital resource, enabling researchers to securely store and access a diverse array of samples, including:
- DNA/RNA
- Whole blood
- Serum
- Saliva
- Urine
- Stool
- Hair
- Cell pellets
- Protein Samples
By providing centralized storage facilities equipped with state-of-the-art preservation technologies, Sampled empowers researchers to accelerate the pace of discovery and validation of novel drug candidates as well as biomarker discovery. Furthermore, our secure facilities are monitored 24 hours a day, all year round with multiple backup power generators to ensure their security and integrity.
2. Preclinical Testing:
As drug candidates progress through preclinical testing, the demand for well-characterized biological samples becomes increasingly critical. Sampled holds both CAP and CLIA licenses so that our biorepository sample storage services facilitate the procurement and distribution of meticulously annotated specimens, thereby streamlining preclinical studies and enhancing the reproducibility of research outcomes. Additionally, by offering customizable sample management and biobanking solutions, Sampled enables researchers to optimize experimental protocols and improve the predictive value of preclinical models, ultimately reducing the risk of late-stage drug failures.
3. Clinical Trials:
Throughout the clinical trial phase, the availability of high-quality biospecimens is indispensable for assessing drug safety, efficacy, and pharmacokinetics. Sampled’s expertise in sample collection, processing, and biosample storage ensures compliance with stringent regulatory requirements while maintaining sample integrity and traceability. By leveraging Sampled’s comprehensive biobanking infrastructure, pharmaceutical companies can mitigate the logistical challenges associated with multi-site clinical trials, streamline sample logistics, and enhance data quality, thereby expediting the development timeline and reducing costs.
The ability to package, transport and store samples in a systematic and highly structured manner by following best practices gives researchers the confidence that their sample’s integrity is intact which means the data generated from them is accurate and reproducible. Furthermore, our ability to scale to meet your sample storage needs through every stage of your clinical trial means that you can focus on what matters most instead of setting up a new, or expanding an existing, biorepository.
4. Post-Market Surveillance:
Even after a drug/therapeutic has been approved for market release, the need for continuous monitoring of safety and efficacy remains paramount. Sampled’s biobanking services extend beyond the realm of drug development and supports post-market surveillance initiatives aimed at detecting adverse drug reactions, monitoring long-term outcomes, and evaluating real-world effectiveness. By establishing longitudinal sample collections linked to comprehensive clinical data, Sampled empowers researchers to conduct retrospective analyses and identify emerging safety signals, thereby safeguarding public health and informing regulatory decision-making.
Similarly, another consideration to be made for pharmaceuticals is how their archived or legacy sample collections (perhaps through acquisitions or donations) are processed and stored. It is crucial that your documenting and SOPs for storing multiple sample collections is standardized across the entire collection so that sample integrity is prioritized but also so that they are categorized correctly. Failure to properly organize and maintain high uniform storage conditions can result in some sample collections being lost, mislabeled or destroyed by mistake.
In conclusion, Sampled’s biobanking services represent a cornerstone of the drug discovery pipeline, offering versatile solutions that span multiple stages of pharmaceutical research and development. By providing researchers with access to a wide range of storage solutions from ambient storage to -196°C Liquid Nitrogen tanks, coupled with robust infrastructure and tailored support services, Sampled accelerates the pace of innovation and fosters collaboration across the biomedical community. As the search for transformative therapies continues, Sampled remains committed to advancing precision medicine and driving the next wave of scientific breakthroughs.
If you would like to learn more about our Biobanking services, speak to one of our experts today