Analytical Development Services
Delivering Tailored Solutions
Our analytical development group delivers tailored solutions to ensure your gene therapy program proceeds with precision and accuracy, from analytical method development and validation to clinical and cGMP manufacturing. Analytical development is the disciplined process of designing, optimizing, and implementing assays and measurements that characterize materials and products. It is important because it ensures data integrity, supports process control, and underpins decisions from research through commercial manufacturing, ultimately safeguarding safety, efficacy, and regulatory compliance.
Ensuring Safety and Efficacy
A critical aspect of gene therapy development is thorough analytical testing, which provides insight into raw material quality and supports process control during drug development and final drug product manufacturing. A crucial, but often overlooked, aspect is device compatibility testing, which ensures the final product can be delivered effectively without loss or degradation. Several key considerations form the basis of a right-sized analytical strategy. These include the main stages of analytical development: defining target product profiles and critical quality attributes, selecting and prioritizing assays, analytical method development, risk-based qualification, method transfer, and ongoing lifecycle management.
Determining the AAV dose via particle and genomic titers is challenging. Assays must be developed and validated early to minimize issues during scale-up and tech transfer. Both capsid and genomic titers require different technologies, introducing potential bias. Common analytical techniques used in analytical development for this purpose include qPCR/ddPCR for genomic titer, ELISA or mass spectrometry for capsid quantitation, and orthogonal assays to reduce bias.
DNA sequencing verifies a construct’s identity and integrity. Sanger sequencing offers quick turnaround for pass/fail analysis. In contrast, next-generation sequencing techniques, such as short-read sequencing, can uncover GC-rich and secondary structures and detect low-frequency variants. Likewise, long-read techniques can offer these insights plus the added capability of evaluating genomic integrity, an increasingly hot topic in the industry today. These are core techniques frequently applied during analytical development to confirm identity and assess variability.
Andelyn’s key asset is our AAV production database, which enables us to minimize the optimization required. We focus on preclinical analytics during development to anticipate cGMP quality control requirements through scale-up across in-process, release, stability, and comparability parameters. Analytical development services in this space include potency assay design, vector genome integrity assessment, and impurity profiling.
We focus on preclinical analytics during development to anticipate cGMP quality control requirements through scale-up across in-process, release, stability, and comparability parameters.
Method Development
The stringent analytical requirements for viral vectors in gene therapy ensure product integrity and regulatory compliance. Analytical development plays a pivotal role in addressing complex challenges ranging from assay variability to evolving regulatory requirements. Decades of experience and a deep understanding of the critical analytical tests and analytical methods enable consistent delivery of safe, consistent, and high-purity products. Analytical method development encompasses selecting appropriate technologies (e.g., HPLC/UPLC, capillary electrophoresis, AUC, ELISA, qPCR/ddPCR, cell-based potency assays), defining acceptance criteria, and optimizing conditions to achieve specificity, sensitivity, linearity, accuracy, and robustness.
Our analytical development services are supported by our state-of-the-art facilities, Andelyn Development Center (ADC) and Andelyn Corporate Center (ACC), ensuring that we meet and surpass the highest standards of quality and safety. Analytical development also differs from method validation: while analytical method development focuses on building and optimizing the assay, method validation formally demonstrates, with predefined protocols and statistics, that the assay meets performance requirements for its intended use.
Method Validation
Method validation has been integral to our development process and manufacturing operations. As we scale up to commercial manufacturing operations, we meticulously adapt assays from the method development process to meet the rigorous standards of large-scale cGMP production of both plasmids and viral vectors. Validation establishes parameters such as accuracy, precision, specificity, detection limits, quantitation limits, linearity, range, and robustness after analytical method development is complete.
Our adaptive approach converts existing R&D assays and also creates new analytical test methods as needed to ensure accuracy and reliability. We recognize the importance of demonstrating comparability over the lifespan of our products, which is why our quality control team remains dedicated to conducting GMP analytics that support our clinical trials and manufacturing phase production. These efforts not only maintain consistency in our materials and across process development but also ensure that our assays meet regulatory requirements and deliver reliable results throughout the pharmaceutical development and product development lifecycle. Analytical development services further include ongoing method lifecycle management, periodic review, and continuous improvement.
We also focus on the identity, purity, and critical quality attributes of every drug substance and drug product, ensuring precision across all development processes. In designing experiments for analytical development, we employ risk assessments, design of experiments (DoE), robustness challenges, and orthogonal confirmation to ensure methods are fit-for-purpose and resilient to variability.
Navigating Analytical Requirements for cGMP Viral Vectors
Our team ensures that large-scale drug substances meet rigorous testing methods and release testing standards across all stages of manufacturing. Analytical development underpins in-process control, release, stability, and comparability, while analytical method development supports effective tech transfer and scalability.
Andelyn Development Center
Explore the heart of innovation at the Andelyn Development Center (ADC), where meticulous process development and advanced analytical capabilities converge. As the cornerstone of Andelyn’s capabilities, ADC expands horizons and meets the evolving demands of our clients through comprehensive analytical development services and robust support for analytical method development.