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class="content-sidebar-wrap"><main class="content"><article class="post-17079 post type-post status-publish format-standard has-post-thumbnail category-general category-pharmamfg category-product-news tag-biologics tag-dpcr tag-qpcr tag-qualtrak entry" aria-label="Streamline Biologics Development With qPCR and dPCR"><header class="entry-header"><h1 class="entry-title">Streamline Biologics Development With qPCR and dPCR</h1> <span class="post-info-author"> By <a href="https://www.thermofisher.com/blog/author/behind-the-bench-staff/" title="Posts by Behind The Bench Staff" rel="author">Behind The Bench Staff</a> </span> <span class="post-info-date"> 09.23.2022 </span> </header><div class="entry-content"><h2>Research, Development, & Manufacturing of Biologics</h2> <h3>A Process With Many Challenges</h3> <p>With the growing demand for biologics to treat and prevent human disease, including vaccines, cell and gene therapies, mAbs, and biosimilars<sup>1-3</sup>, manufacturers who can quickly deliver safe and effective products will be in the best position to leverage growth opportunities and capture biologics market share.</p> <p>However, researching, developing, and manufacturing biologics is an arduous and expensive process fraught with regulatory and supply chain challenges. It can take an average of 10 years and $2.6 billion to develop a new biologic medicine, and only 12% of candidates make it to market<sup>4</sup>. Others end up in “the valley of death”—the transition from laboratory to trial where candidates often fail.</p> <p>With such tremendous potential challenged by drastic implications for time and resources, commercial collaborators who provide advancements in efficiency, speed, quality, and regulatory support can help biologics manufacturers bridge the gap from basic research to clinical trials and manufacturing.</p> <h2>PCR Is an Essential Technology in Biologics Development and Manufacturing</h2> <h3>Simplify Your Workflows and Maximize Your Development Process</h3> <p>Detection and quantification of nucleic acid targets are essential in comprehensive quality control (QC) testing for a wide variety of biologics performance specifications. PCR methods such as quantitative real-time PCR (qPCR) and digital PCR (dPCR) are the gold standards for sensitive, specific detection and quantification of nucleic acid targets. They have become core technologies for delivering high-quality results throughout biologics development and biomanufacturing. Working with a provider who can simplify your workflows with a comprehensive qPCR technology ecosystem can be central to maximizing the speed and efficiency of your biologics development process.</p> <h2>A Comprehensive qPCR Ecosystem for End-to-End Biologics Development</h2> <p><img decoding="async" class="alignright wp-image-17095 size-full" style="background-color: #fff" title="QualTrak Comprehensive qPCR Ecosystem for End-to-End Biologics Development" src="https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/scientists-working-lab-qualtrak-biopharma-qpcr.jpg" alt="Scientists working in lab developing biologics with QualTrak PCR products." width="380" height="214" srcset="https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/scientists-working-lab-qualtrak-biopharma-qpcr.jpg 380w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/scientists-working-lab-qualtrak-biopharma-qpcr-300x169.jpg 300w" sizes="(max-width: 380px) 100vw, 380px" /><a title="QualTrak™ qPCR & dPCR Biopharma Ecosystem - Streamline development and simplify compliance" href="https://www.thermofisher.com/us/en/home/life-science/pcr/real-time-pcr/biopharma.html">Applied Biosystems™ QualTrak™ qPCR ecosystem for BioPharma</a> is a <strong>comprehensive suite of real-time PCR and digital PCR tools</strong> that have been curated to streamline biologics development from discovery through clinical trials and cGMP manufacturing. QualTrak offerings include a premium selection of QuantStudio instruments, optimized master mixes, predesigned and custom assays, and suggested workflows. To help ensure reproducibility and traceability in post-discovery phases of the pipeline, QualTrak workflows feature Taqpath master mixes and assays manufactured in an ISO 13485-certified and FDA-registered facility that adheres to the principles of current good manufacturing practices (cGMP).</p> <p><strong>QualTrak qPCR and dPCR</strong> products are highly <strong>specific</strong>, <strong>sensitive</strong>, <strong>accurate</strong>, and <strong>reproducible qPCR analysis </strong>technologies that can be used to validate key nucleic acid sequences for transgene and vector assembly, quantification of mRNA expression, identification of cell culture contamination, and more. They enable investigations into antigen identification and screening, biomarker identification, pathogen biology, therapeutic efficacy, safety, and host response at each step of mAb, vaccine, gene therapeutics or cell therapeutics development from discovery through clinical trials. QualTrak solutions are also essential tools for collecting QC data to demonstrate compliance with regulatory requirements for genetic consistency, reliability, and regulatory conformity in nucleic acid and cell line therapeutic development. Once regulatory agencies have approved a biologic for a specific bioprocess, qPCR or dPCR can also be used to maintain product performance through manufacturing quality control and adherence to established lot-release criteria.</p> <h3>QuantStudio Instrumentation Enables Smarter Workflows</h3> <h4>Advanced Features Maximize Efficiency</h4> <p><img decoding="async" class="aligncenter wp-image-17090 size-large" style="background-color: #fff" title="QuantStudio Instrumentation Enables Smarter Workflows" src="https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Biopharma-QS7Pro-1930x1086-1-1024x576.png" alt="Scientist in clean room suit and mask using QuantStudio instrument." width="760" height="428" srcset="https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Biopharma-QS7Pro-1930x1086-1-1024x576.png 1024w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Biopharma-QS7Pro-1930x1086-1-300x169.png 300w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Biopharma-QS7Pro-1930x1086-1-768x432.png 768w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Biopharma-QS7Pro-1930x1086-1-1536x864.png 1536w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Biopharma-QS7Pro-1930x1086-1.png 1930w" sizes="(max-width: 760px) 100vw, 760px" /><a title="QuantStudio 6 and 7 Pro Real-Time PCR Systems" href="https://www.thermofisher.com/us/en/home/life-science/pcr/real-time-pcr/real-time-pcr-instruments/quantstudio-systems/models/quantstudio-6-7-pro.html" target="_blank" rel="noopener">Applied Biosystems™ QuantStudio™ 7 Pro Real-Time PCR Systems</a> help improve user experience with <strong>smarter workflows to speed biologics research and innovation</strong>. High-throughput, automation-ready instruments also reduce error-prone manual tasks and enable full-time unattended operation to maximize consistency, efficiency, and productivity throughout the biologics development process. QuantStudio system software also has features that enable compliance with 21 CFR Part 11 to efficiently digitize and secure your data.</p> <h5>Ease of Use</h5> <p>With QuantStudio 7 Pro, exceptional advancements in user control and ease-of-use deliver a new level of productivity. Interchangeable blocks help increase throughput and assay flexibility, while voice commands, hands-free operation, remote instrument access, push-button help access, and automatic facial authentication offer greater security and more efficient troubleshooting.</p> <h5>Thermal Cycling</h5> <p>The quality of a PCR instrument’s thermal cycling and blocks is a core aspect to effectively pairing excellent assay consistency with high throughput. To this end, most QuantStudio real-time PCR systems incorporate industry-leading Applied Biosystems™ VeriFlex™ temperature control technology to give users the utmost command over thermal cycling. VeriFlex blocks offer high accuracy (set point vs. actual temperature) and precise temperature zones for reliable and rapid determination of optimal annealing temperatures and data collection.</p> <h5>Reproducibility</h5> <p>QuantStudio 7 Pro instruments also offer exceptional reproducibility, demonstrating minimal well-to-well and instrument-to-instrument variation to help ensure data concordance across runs. With these advanced features, QuantStudio instruments are primed to accelerate critical nucleic-acid-based investigations in your biologics program, all while minimizing labor-intensive steps and maximizing user efficiency.</p> <h3>dPCR Delivers Ultra-Sensitive and Precise Quantitation of Nucleic Acids</h3> <p><strong>Digital PCR (dPCR)</strong> has emerged as a powerful tool for <strong>accurate</strong> and <strong>precise quantification of nucleic acids</strong> without the need for reference samples or standard curves. <a title="QuantStudio Absolute Q Digital PCR System" href="https://www.thermofisher.com/us/en/home/life-science/pcr/digital-pcr/quantstudio-absolute-q-system.html" target="_blank" rel="noopener">Applied Biosystems™ QuantStudio™ Absolute Q™ Digital PCR System</a> uses a unique microfluidic array plate (MAP) technology that delivers powerful quantitation with straightforward operation. MAP technology automates the compartmentalization of PCR reactions into 20,000 microchambers with a best-in-class coefficient of variation (CV) of <1%. Unlike emulsion or other droplet-based methods used to compartmentalize reactions, MAP technology delivers reagents to the microchambers through distribution channels that provide excellent precision and consistency. The QuantStudio Absolute Q system analyzes more than 95% of the loaded sample, ensuring highly accurate digital PCR results with less wasted sample and reagents.<img loading="lazy" decoding="async" class="aligncenter wp-image-17081 size-full" style="background-color: #fff" title="dPCR Delivers Ultra-Sensitive and Precise Quantitation of Nucleic Acids" src="https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Absolute-Q-0104-650x600-1.jpg" alt="Applied Biosystems Absolute Q digital PCR system" width="650" height="600" srcset="https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Absolute-Q-0104-650x600-1.jpg 650w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Absolute-Q-0104-650x600-1-300x277.jpg 300w" sizes="(max-width: 650px) 100vw, 650px" /></p> <h3>TaqMan and TaqPath Products Support qPCR Applications From Research to Commercial Manufacturing</h3> <p>For discovery research qPCR applications, <a title="TaqMan Real-Time PCR Master Mixes" href="https://www.thermofisher.com/us/en/home/life-science/pcr/real-time-pcr/real-time-pcr-reagents/taqman-real-time-master-mixes.html" target="_blank" rel="noopener">Applied Biosystems ™ TaqMan™ Master Mixes</a> and <a title="TaqMan Real-Time PCR Assays" href="https://www.thermofisher.com/us/en/home/life-science/pcr/real-time-pcr/real-time-pcr-assays.html" target="_blank" rel="noopener">Applied Biosystems™ TaqMan™ Assays</a> offer trusted performance with high specificity, flexibility, and consistency.</p> <p>For post-discovery phases of the pipeline, <a title="TaqPath qPCR and RT-qPCR Master Mixes" href="https://www.thermofisher.com/us/en/home/clinical/diagnostic-development/molecular-diagnostic-test-development/consumables-reagents-clinical-reagents/taqpath-qpcr-master-mixes.html" target="_blank" rel="noopener">Applied Biosystems™ TaqPath™ Master Mixes</a> and <a title="TaqPath Assays and Probes in Biopharma" href="https://www.thermofisher.com/us/en/home/life-science/pcr/real-time-pcr/biopharma/taqpath-assays-probes.html" target="_blank" rel="noopener">Applied Biosystems™ TaqPath Assays and Probes</a> build on the trusted performance of TaqMan products to offer the increased support, traceability, and documentation required for late-stage development, clinical trials, and commercial manufacturing. These products are manufactured in an ISO 13485-certified and FDA-registered facility that adheres to the principles of cGMP for ultimate reliability. TaqPath master mixes are tested to the most rigorous analytical and functional lot release QC in the industry to deliver exceptional lot-to-lot consistency and include easily accessible support documentation, including:</p> <ul> <li>Lot-specific Certificate of Analysis with QC data</li> <li>Site QMS certification</li> <li>Product Stability Declaration</li> <li>Animal-free Origin Declaration</li> <li>Product Statement of Quality</li> <li>Change notification</li> <li>Supply questionnaire</li> <li>MSDS for REACH compliance</li> </ul> <h4>TaqPath Master Mixes – Reliable and Accurate</h4> <p>TaqPath master mixes deliver uncompromising reliability and accuracy even in the presence of inhibitors commonly found in biopharma samples. For added assurance, these products also help control for common sources of variability, including passive references to compensate for small fluorescence fluctuations, inhibitor tolerance controls sample-to-sample variability, and uracil-N-glycosylase (UNG) prevents carryover contamination.</p> <p>TaqPath master mixes are optimized to support a range of applications. Maximize productivity in high-throughput genotyping and CNV assays with sensitive and reproducible detection of up to four DNA targets in a single multiplex qPCR reaction using <a title="TaqPath ProAmp Master Mixes" href="https://www.thermofisher.com/us/en/home/life-science/pcr/real-time-pcr/real-time-pcr-reagents/taqman-real-time-master-mixes/taqpath-proamp-master-mixes.html" target="_blank" rel="noopener">>Applied Biosystems™ TaqPath™ ProAmp™ Multiplex Master Mix.</a> Or solidify quality control testing with ultra low-level detection of bacterial, fungal, mammalian, and viral DNA using <a title="TaqPath BactoPure Molecular Diagnostics" href="https://www.thermofisher.com/us/en/home/clinical/diagnostic-development/molecular-diagnostic-test-development/consumables-reagents-clinical-reagents/taqpath-qpcr-master-mixes/taqpath-bactopure.html" target="_blank" rel="noopener">Applied Biosystems™ TaqPath™ BactoPure™ Microbial Detection Master Mix</a>. This master mix is ultra-pure to remove background DNA, thereby enabling down to single-copy detection of low-level targets – even in the presence of PCR inhibitors. TaqPath BactoPure generates reliable data over a wide linear dynamic range to enable accurate detection in low- and high-DNA-concentration samples and delivers exceptional lot-to-lot performance.</p> <p><img loading="lazy" decoding="async" class="aligncenter wp-image-17089 size-large" style="background-color: #fff" title="Applied Biosystems QualTrak qPCR Ecosystem for BioPharma" src="https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Bactopure-Biopharma-1930x1086-1-1024x576.png" alt="Applied Biosystems Bactopure product box in a laboratory being used by scientists in clean room suits and masks." width="760" height="428" srcset="https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Bactopure-Biopharma-1930x1086-1-1024x576.png 1024w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Bactopure-Biopharma-1930x1086-1-300x169.png 300w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Bactopure-Biopharma-1930x1086-1-768x432.png 768w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Bactopure-Biopharma-1930x1086-1-1536x864.png 1536w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Bactopure-Biopharma-1930x1086-1.png 1930w" sizes="(max-width: 760px) 100vw, 760px" /></p> <h4>TaqMan Assays – Maximize Productivity – Predesigned or Customized</h4> <p>Maximize productivity with exactly the assays you need. TaqMan assays are available either predesigned for maximum convenience or customized with your unique markers. Predesigned and custom assay formats can also increase the reproducibility and speed of your qPCR analysis. By working with a proven vendor of customized assays used in biologics development, you can reduce or eliminate assay development and validation time and be sure that consistency is inherent to the assay. Elevate plate tracking and data security with radio-frequency identification (RFID) plate tagging on <a title="TaqMan Array Plates with RFID - One simple step gets you to your data faster" href="https://www.thermofisher.com/us/en/home/life-science/pcr/real-time-pcr/real-time-pcr-assays/taqman-gene-expression/96-well-taqman-gene-expression-assays/taqman-array-plates-rfid.html" target="_blank" rel="noopener">Applied Biosystems™ TaqMan™ Array plates</a> on the QuantStudio 7 Pro System. Plate layout and assay information are automatically transferred, followed by seamless transfer of assay data to your EDS file.</p> <h2>The QualTrak Ecosystem Supports Regulatory Compliance</h2> <p>As interest and opportunity for mAb, vaccine, cell and gene therapies, and biosimilars grow, the complexity of associated regulatory requirements grows. The rapidly expanding capabilities and applications for biologics mean that the regulatory environment is changing rapidly.</p> <p>Biologics manufacturers are no different from chemical-pharmaceutical manufacturers in needing to <strong>demonstrate compliance with regulatory specifications</strong> for efficacy, safety, bioburden, monitoring, sterility, detection, and identification of impurities, and long-term stability.</p> <p>For biologics manufacturers, adhering to requirements through product development and long-term use demands the utmost consistency and data integrity in usage, production, and storage. Robust quality management systems encompassing the full biologics development process from raw materials to final manufacturing are essential to ensure strategy aligned with cGMP guidelines for design, monitoring, and control of manufacturing processes and facilities. Commercial partners must uphold the utmost commitment to data integrity in service-level agreements (SLAs) and laboratory information management system (LIMS)-integrated software.</p> <p><img loading="lazy" decoding="async" class="aligncenter wp-image-17087 size-large" style="background-color: #fff" title="QualTrak Ecosystem is Full-Featured and Supports Regulatory Compliance" src="https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Biopharma-Scientist-Portal-1930x1086-1-1024x576.png" alt="Scientist in clean room suit and mask sitting at work table with computer logged into portal" width="760" height="428" srcset="https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Biopharma-Scientist-Portal-1930x1086-1-1024x576.png 1024w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Biopharma-Scientist-Portal-1930x1086-1-300x169.png 300w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Biopharma-Scientist-Portal-1930x1086-1-768x432.png 768w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Biopharma-Scientist-Portal-1930x1086-1-1536x864.png 1536w, https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2022/09/Biopharma-Scientist-Portal-1930x1086-1.png 1930w" sizes="(max-width: 760px) 100vw, 760px" /></p> <h3>QualTrak Suite Designed to Support cGMP, CFR 21 Part 11 Compliance</h3> <p>In addition to being manufactured under the principles of GMP, the complete QualTrak suite of master mixes, predesigned and custom assays, and software are designed, built, and formulated to support cGMP compliance. All QualTrak qPCR and dPCR instruments and software tools are also assist with CFR 21 Part 11–compliance.</p> <h4>Documentation and Support</h4> <p>A partner that is up-to-date and can provide you with the most current compliance documentation is key to a streamlined manufacturing process. We enable our partners with consistent, ongoing regulatory support by providing the most current compliance documentation for all QualTrak products throughout the PCR workflow and instrument <a title="Instrument Hardware Qualification Services" href="https://www.thermofisher.com/us/en/home/products-and-services/services/instrument-qualification-services/compliance-and-validation/instrument-iq-oq-ipv.html" target="_blank" rel="noopener">IQ/OQ/IPV support services</a>.</p> <h3>Assure Uninterrupted qPCR and dPCR Operations With a Reliable Supply Chain</h3> <p>Maximize your biologics operational strategy options with a global and diversified supply chain. Supply chain continuity is a critical component of ensuring uninterrupted PCR operation to contribute to a successful biologics program. We source the goods and services that comprise all QualTrak products worldwide, providing you with resilience against damaging circumstances such as cyberattacks, adverse weather events, geopolitical events, and pandemics. Our risk management programs map and monitor our supply chain networks to minimize risk based on supplier performance, geographic exposure, and environmental practices. Working with a partner who provides demonstrated supply chain robustness can ensure your biologics manufacturing operation is resilient and scalable to meet your evolving demands.</p> <h2>Work With the Optimal Partner to Ensure High-Performance qPCR for Your Biologics Development</h2> <p>Fast-track your mAb, vaccine, cell and gene therapies, or biosimilars development program. Together, the innovative and user-friendly <strong>QualTrak qPCR and dPCR</strong> instrumentation, predesigned and custom assays, and optimized master mixes encompass a complete ecosystem that can help you overcome hurdles in biologic therapeutics development. A partner who is there to maximize PCR workflow productivity and efficiency from discovery through development, manufacturing, and clinical trials can help you drive an investigational candidate to the finish line quickly.</p> <p> </p> <p> </p> <p>—</p> <h2>References</h2> <ol> <li>Lu RM, Hwang YC, Liu IJ, et. al. (2020). Development of therapeutic antibodies for the treatment of diseases. <em>Journal of Biomedical Science </em>27(1).</li> <li>Chen Y, Monnard A, Santos da Silva J (7 June 2021). “An inflection point for biosimilars.” <em>McKinsey & Company.</em></li> <li>Global Cell and Gene Therapy Market Report 2020: Market to recover and grow at a CAGR of 24.1% in 2023. (7 January 2020) <em>Business Wire.</em></li> <li>Campbell H (26 August 2015). “Video & infographic: Developing a new drug is actually harder than rocket science,” <em>PhRMA</em>.</li> </ol> <p>TaqPath Products are For Laboratory Use Only. TaqMan Products and QuanStudio 7 Pro Systems, and QuantStudio Absolute Q products are for Research Use Only.</p> <p>© 2022 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. 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