It is easy to get overwhelmed by the noise and constant movement in the biopharmaceutical space. With the transfer of data and information at its peak as a society, the science sector is no different. It can quickly become difficult to know who to trust and rely on to support your pre-clinical and clinical processes. Locating a source of consistency and dependability only becomes more and more vital as an asset matures.
Cell & Gene Therapy is no different, and oftentimes even more overwhelming, given its recent uptick and relevance as bioscience continues to advance. At K2bio, we believe in offering what is impactful, relevant, and readily needed by our market. That is the reason why we’ve chosen to offer Droplet Digital PCR (ddPCR). ddPCR is a quantitative PCR that creates and examines thousands of tiny oil-based droplets. Samples are partitioned into droplets prior to the PCR reaction and through partitioning, ddPCR can obtain a specific count of target DNA molecules, rather than approximating the quantity based on bulk fluorescence. Each droplet has PCR reactionary information for your analysis, enabling absolute quantification rather than the relative quantification utilized by real-time PCR.
Many are familiar with real-time PCR and how it functions in many clinical processes. Real-time PCR requires intricate sample preparation, as well as establishing a standard curve to obtain information about your sample. This process can be timely and introduces risk and potential inconsistencies related to pipetting techniques and day-to-day variations. Alternatively, with the ddPCR, sample preparation can be minimal and each sample is separated into thousands of singular droplets, which increases your statistical power without the need for a standard curve. ddPCR also allows for the detection of very low copy numbers of a specific target. This method of analysis helps to reduce time, variability between scientists, and provides a more controlled process for quantitative data.
If you have a low volume of sample, ddPCR is a great method to maximize the data incurred from what you have available. You can also multiplex the goal of this process, creating multiple targets to be gauged, as opposed to one. The ddPCR process is a quick and more granular selection, even with a small sample size.
ddPCR utilization within cell and gene therapy is relatively new, having entered the scene in the last couple of decades. Instrumentation and process advancements have picked up rapidly and even been employed in wastewater testing. Relevance in terms of Cell & Gene therapy has become increasingly potent in the last few years, and numerous companies have now employed the technology to optimize data collection and quantitative samples.
K2bio has carefully monitored ddPCR advancements and applications, ensuring that we are offering our industry the very best tools for sample analysis. We have been on the cutting edge of advancement in this area of the industry for several years now and are more than equipped to help you navigate assay development, if this is new for you, as well as optimize it in a way that works for you specifically, if you are more experienced in the overall process. If you’re unsure of how this may uniquely apply, ddPCR in actual application works impressively for quantifying genome editing events, detecting and quantifying residual plasmid or host-cell DNA, differentiating copies per genome, assessing genome integrity, precisely quantitating nucleic acids, absolute quantification for tittering and direct counting of rare events in complex background DNA. It has also been used to measure dose-dependent expression of transgene DNA for low, mid, and high ranges.
The relevance of ddPCR within the biopharma sector cannot be understated, nor can the range of other values we work diligently to provide each client. K2bio works on a collaborative level, working with you one-on-one to coordinate our processes with your precise goals. We work with you to evaluate what you truly need to reach your goals and offer a wealth of information on how to arrive there, if you desire any guidance in your journey.
ddPCR equipment is readily available at DNA core labs within academia but can be scarce in incubators and CRO’s. We offer access to these necessary tools to bring these tests to life for you and your sample. We employ state-of-the-art technology in a new field and make it readily available for you.
K2bio has found a way to work with biotechs in a very fluid and flexible manner. Many of the research projects that come to us are run by small groups of individuals, sometimes three or fewer. There are many ways that these projects can become ongoingly more complex and overwhelming to manage, and we take great pride in minimizing those challenges and being readily available to work with smaller companies, no matter where they are in their pipeline.
Having ddPCR available to our customers aligns perfectly with our company’s intention of bringing quality and efficient services to the market. In reference to this method, we accomplish this by providing a process that is faster, more accurate, more granular, and only uses a small sample size. Midsize biotech and smaller startups currently reaching the clinical phase of their trials are perfect candidates to work with us and allow us to optimize their processes and provide meaningful data.
With over 8,300 publications, ddPCR is still a growing application in the biopharma sector. At K2bio we will continue to analyze cutting-edge innovations and stay current with technologies that benefit the advancement of your ideas. You can find comfort when utilizing our services, knowing that you are interfacing with a company that is committed to a deeper understanding of how new applications can be applied to products in a way that drives quality, efficiency and value.