Molecular Biology Services for Every Development Stage
In today’s rapidly evolving landscape of drug development, the challenge lies in efficiently harnessing the potential of nucleic acid therapeutics. With our comprehensive molecular biology testing, our experts will guide you through every stage of your drug development journey – from early discovery through clinical trials.
By leveraging state-of-the-art global facilities and expert teams, you gain the tools and insights needed to develop revolutionary viral, DNA, RNA, or cell-based therapies, ensuring precision, accuracy, and compliance with regulatory standards.
Molecular Biology Testing is Bridging the Gap
Within drug development, the gap between innovative potential and execution often feels overwhelming for researchers aiming to develop life-changing therapies. Many find themselves hindered by the intricate challenges of nucleic acid extraction and analysis, leading to frustration and lost opportunities.
Our molecular biology services are a transformative solution, offering tailored support and advanced technology to remove obstacles and streamline workflows. Now more than ever, the urgency for effective treatments has intensified, and we are here to ensure that every visionary idea has the best chance to flourish, bringing us closer to a future where medical breakthroughs are a reality.
eGuide: Bioanalysis from Early-Stage to Clinical Drug Development
Accounting for modality complexity, evolving regulatory expectations, and the critical importance of upfront planning, this eGuide explains how to identify risks early and align your bioanalytical strategy with the needs of your compound, your timeline, and your team.
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My first experience with Charles River was as a client, and what impressed me most was the commitment to troubleshooting and finding solutions. Collaboration is key—we ensure clear understanding of clients’ needs from the very first client meeting. With experience spanning discovery to clinical, our scientists manage every step in the drug development process. Globally harmonized sites across the US, Europe, and Canada deliver consistent quality, and recent automation investments make our processes even more cost-efficient."
Catherine Spickler, Associate Director of the Immunochemistry Department, Laval, Canada
Comprehensive Molecular Biology Services
Cell and gene therapy products, including nucleic acid therapeutics, are at the forefront of modern medicine. We have supported our partners in the development of many viral, plasmid, and cell-based drug products through our comprehensive molecular biology assays.
Expertise with Diverse Nucleic Acid Therapeutics
- Provide comprehensive and cutting-edge solutions for nucleic acid therapeutic development.
- Equipped to work with a variety of nucleic acids such as DNA, RNA, and modified oligonucleotides.
- Customized laboratories and specialized equipment for siRNA, mRNA, and gene therapy products.
- Handle all aspects of nucleic acid extraction, reagent preparation, and amplification/detection with precision and efficiency.
Real-Time Quantitative and Reverse Transcriptase PCR (qPCR, ddPCR)
- Assessments of nucleic acid therapeutics, including biodistribution/shedding studies and quantitation of the transgene mRNA for gene and cell therapies
- Gene expression analysis
- Cytokine mRNA profiling in immune response
- Biomarker assessment
- CYP mRNA induction
- Ex vivo mRNA profiling in liver
Molecular Biology Assays
- Reporter gene assays
- Genomic and plasmid DNA isolation
- Residual mammalian DNA detection by hybridization analysis
- Total RNA isolation
- Assay feasibility, development, and validation
- Biological sample analysis
- GLP/non-GLP study designs and reporting
Technical Capabilities Enabling Nucleic Acid Therapeutics
- QIAcube Connect®, QIAsymphony®, Promega Maxwell®
- Real-time quantitative PCR platforms capable of supporting multiple fluorescent chemistries
- QX One® ddPCR system (digital droplet PCR technology)
- Luminex®-based QuantiGene® system
- Bioluminescent reporter gene assays
- Allelic discrimination assays (TaqMan® probe chemistry)
Biodistribution/Shedding Studies
- Detailed biodistribution and shedding data required by regulatory authorities.
- Expertise in genomics for in vivo and ex vivo biodistribution studies.
- Thorough understanding of nucleic acid therapeutics and regulatory expectations.
- Ability to investigate a wide range of compounds (vaccines, cells, plasmids, viruses).
qPCR Validation Studies
- Detection system for qPCR, ddPCR, and gene-specific recovery procedures.
- Detect as little as five copies of gene or cell DNA in all tissue types.
- Additional molecular biology services for specialty areas such as DART.
- qPCR validation includes precision/accuracy, dynamic range, detection limit, inhibition monitoring, specificity, and selectivity.
Bioanalytical Strategies Unlocked: Innovative Approaches to PK, Immunogenicity, and Biomarkers
In this webinar, our scientific experts will walk you through real-world case studies that illustrate how innovative bioanalytical approaches can help you overcome common hurdles in pharmacokinetics (PK), immunogenicity, and biomarker applications.
Watch the Replay
How do I choose the right partner for my molecular biology testing?
Can your partner offer a comprehensive range of services for every stage of therapeutic development, guiding you through each step of your journey to the clinic?
Expertise Across Complex Modalities
You can rely on our unparalleled experience in the molecular biology analysis of complex modalities, including many viral, plasmid, and cell-based therapeutics. We bring real-world learnings to help you anticipate challenges and troubleshoot to keep your programs on track.
Global Regulatory Expertise
Our global laboratory footprint and in-house scientific advisory services ensure we can guide you through challenging and shifting global regulatory environments. You can seamlessly move from one development stage to the next, capturing the critical data you need.
Flexibility and Scalability to Suit Your Needs
By partnering with our molecular biology services teams, together we can create an analytical strategy that meets your needs using our experience of working with biotech and pharma clients of all sizes. Whether you need a small, niche solution or you need to scale your program, we can meet your evolving needs.
Frequently Asked Questions (FAQs) About Molecular Biology Services
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How do you ensure the quality and accuracy of your nucleic acid extraction and amplification processes?
Our state-of-the-art molecular biology services facilities treat quality and accuracy with the utmost importance. Our custom-designed laboratories have separate areas for each step of the extraction and amplification process to minimize the risk of cross-contamination.
Our team of highly trained experts follows strict protocols and procedures to ensure that every sample is processed accurately and efficiently. We also use advanced technology and equipment to perform rigorous quality control checks throughout the entire process.
We also conduct audits and reviews regularly to continuously improve our processes and maintain the highest standards of quality in our nucleic acid extraction and amplification services. You can rest assured knowing that your nucleic acid therapeutics are being developed with the highest level of precision and care.
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How do your custom-designed laboratories minimize cross-contamination during sample processing?
Our molecular biology services facilities have been carefully designed with separate and dedicated areas for sample processing, reagent preparation, and amplification/product detection. This means that each step of the process is carried out in a specific area to minimize the risk of cross-contamination between samples.
For example, our nucleic acid extraction process takes place in a designated laboratory with specialized equipment to ensure the purity and integrity of each sample. The reagents used in this process are prepared in a separate area to prevent any contamination from outside sources. Similarly, our amplification/product detection area is equipped with state-of-the-art technology and is kept completely sterile to prevent any interference from other samples.
By following these strict protocols and utilizing custom-designed laboratories, we can confidently guarantee that our molecular biology services provide accurate and reliable results without the risk of cross-contamination.