Therapeutic Pipeline
Consultative Assay Services from Discovery to Clinical.
Ensure that the therapies of tomorrow are designed safely today.
Early-Stage R&D
Comprehensive Assay Solutions for Advanced Genomic Research
Visualize small targets and create custom multiplexed data sets that suit your research goals. Our scientists will partner with you to create custom assay and probe designs for superior execution and imaging analysis.
Structural Variant Baseline
Establish a robust baseline for detecting structural variants in your samples. Our sophisticated techniques ensure precise identification and characterization of large genomic rearrangements, aiding in the understanding of genetic diversity and disease mechanisms.
Vector Comparison
Optimize your research by comparing different vectors for gene delivery. Our detailed vector comparison analysis evaluates efficiency, integration patterns, and overall performance, helping you select the best vector for your experimental needs.
Edit Modality
Understand the impact of different editing modalities on your genomic experiments. Whether using CRISPR, TALENs, or other gene-editing tools, we provide comprehensive assessments to ensure accurate and effective genetic modifications.
DNA Damage Assessment
Ensure the integrity of your genetic material with our DNA damage assessment services. We utilize cutting-edge techniques to detect and quantify DNA damage, providing crucial insights into the effects of environmental factors, chemical agents, and genetic engineering.
Delivery Optimization
Maximize the efficiency of your gene delivery systems. Our delivery optimization services focus on enhancing the precision and effectiveness of your delivery methods, ensuring that your genetic material reaches the desired targets with minimal off-target effects.
Pivotal Batch Analysis
Gain critical insights with our pivotal batch analysis services. We perform thorough analyses of key batches in your production or experimental pipeline, ensuring consistency, reliability, and high-quality results.
Partner with us to elevate your research with customized, high-precision assay solutions designed to meet the unique challenges of your scientific endeavors.
Clinical R&D
Advanced Solutions for Cell Therapy and Genomic Editing
Our extensive expertise in genomics and cell therapy enables us to provide comprehensive solutions tailored to your research needs. From donor qualification to precise transgene mapping, we offer a wide range of services designed to ensure the success of your projects.
Donor Qualification
Ensure the highest quality starting material with our rigorous donor qualification processes. We assess donor suitability based on genetic markers, health status, and other critical factors to provide you with reliable and consistent sources for your cell therapy and research projects.
Baseline Structural Variance
Establish a clear baseline for structural variance in your genetic samples. Our detailed analysis identifies and characterizes structural variations, providing crucial insights into genetic diversity, disease mechanisms, and the potential impact of therapeutic interventions.
Cell Therapy Pipeline Development
Accelerate your cell therapy projects with our end-to-end pipeline development services. From initial concept through to clinical application, we support every stage of your development process, ensuring robust, reproducible, and regulatory-compliant outcomes.
Editing Method Variability
Optimize your gene editing strategies by understanding the variability between different editing methods. We provide comprehensive assessments of various gene-editing tools, including CRISPR, TALENs, and ZFNs, to ensure accurate, efficient, and safe genetic modifications.
On- and Off-Target Edit Sites
Achieve precise gene editing with our on- and off-target site analysis. We meticulously evaluate the specificity of your gene editing efforts, identifying unintended off-target effects and confirming the accuracy of on-target modifications to enhance the reliability of your results.
Transgene Mapping
Map your transgenes with precision using our state-of-the-art techniques. Our transgene mapping services provide detailed insights into the integration sites, copy number, and stability of your transgenes, ensuring successful and predictable expression in your research and therapeutic applications.
Partner with us to leverage our expertise in genomics and cell therapy, and take your research to new heights with customized, high-precision solutions designed to meet the unique challenges of your scientific endeavors.
Initial New Drug (IND) Filings
Comprehensive Solutions for IND Filings: Ensuring Success in Drug Development
Navigating the complexities of IND filings requires precision, reliability, and expert insights. Our specialized services are designed to support every aspect of your IND filing process, from engineering batch expansion to detailed structural variation assessments. Explore our tailored solutions below:
Engineering Batch Expansion
Achieve optimal scalability with our engineering batch expansion services. We provide comprehensive support to expand your batches efficiently, ensuring consistency and quality across all production stages. Our approach minimizes variability and maximizes the reliability of your engineered products.
Performance Variability
Mitigate risks with our thorough performance variability assessments. We analyze the performance of your therapeutic products under various conditions to identify potential inconsistencies. This ensures that your product meets the stringent requirements necessary for IND approval and clinical success.
Stability
Guarantee the longevity and efficacy of your products with our stability testing services. We conduct rigorous stability studies to determine the shelf-life and storage conditions of your products, providing you with the data needed to ensure consistent performance throughout their lifecycle.
Custom Reporting
Streamline your IND filing process with our custom reporting solutions. We generate detailed, regulatory-compliant reports tailored to your specific requirements, providing clear and comprehensive documentation to support your IND submissions and regulatory communications.
Transgene Mapping
Enhance the predictability and safety of your gene therapies with our precise transgene mapping services. We offer detailed analyses of transgene integration sites, copy number, and expression stability, ensuring your therapeutic genes are accurately and safely incorporated.
Structural Variation Assessment
Understand the genetic landscape of your products with our structural variation assessment services. We identify and characterize structural variants within your engineered cells, providing crucial insights into genetic stability and potential impacts on therapeutic efficacy and safety.
Partner with us to navigate the intricacies of IND filings with confidence. Our expert team and advanced technologies are dedicated to supporting your drug development journey, ensuring your products meet the highest standards of quality and regulatory compliance.
Clinical I, II, III
Comprehensive QC Batch Testing for Clinical Trials
Ensuring the safety and efficacy of your therapeutics at every clinical phase is crucial for successful drug development. Our specialized services for QC batch testing, structural variant evaluation, and genomic integrity testing provide the robust data needed to support your clinical trials from Phase I through Phase III. Explore our tailored solutions below:
QC Batch Testing
Guarantee the quality and consistency of your therapeutic products with our rigorous QC batch testing services. We conduct comprehensive testing on each batch to ensure they meet the highest standards of purity, potency, and safety.
Structural Variant Evaluation
Understanding the structural variants in your genomic material is essential for ensuring the safety and effectiveness of your therapeutics. Our structural variant evaluation services provide in-depth analysis to identify and characterize all types of genomic rearrangements, such as:
- Insertions and Deletions:Detecting the presence of additional or missing genetic material.
- Copy Number Variations:Assessing changes in the number of copies of particular genes or genomic regions.
- Translocations:Identifying abnormal rearrangements of genetic material between different chromosomes.
- Inversions:Detecting segments of DNA that are reversed within the genome.
By thoroughly evaluating these structural variants, we help you understand their potential impact on your therapeutic products and ensure they meet regulatory standards.
Genomic Integrity Testing
Maintaining the genomic integrity of your therapeutic products is critical for ensuring their safety and efficacy. Our genomic integrity testing services offer comprehensive assessments to detect and quantify genetic stability, including:
- Off-Target Effects: Evaluating unintended genetic modifications resulting from gene-editing technologies.
- Genomic Stability: Monitoring the consistency of the genomic material over time and across different batches to ensure long-term reliability.
- Detailed Custom Reporting: Providing a pair-wise comparison between your wild type and treated cells.
By providing detailed insights into the genomic integrity of your products, we help you mitigate risks and ensure compliance with regulatory requirements.