Analytical Development
Delivering Tailored Solutions
Our analytical development group delivers tailored solutions to ensure your gene therapy program proceeds with precision and accuracy, from method development to validation.
Ensuring Safety and Efficacy
A critical aspect of AAV development is thorough analytical testing which provides insight into raw material quality and ensures process control during development and manufacturing of the final product. A crucial, but often overlooked, aspect is device compatibility testing ensuring the final product can be effectively delivered without loss or degradation. There are a number of key considerations in AAV that form the basis of a right-sized analytical strategy. These include:
Determining AAV dose via particle and genomic titer is a challenge. Assays must be developed early to minimize issues during scale-up and tech transfer. Both capsid and genomic titers require different technologies, introducing potential bias.
DNA sequencing verifies a construct’s identity and integrity. Sanger sequencing offers a quick turnaround for pass/fail analysis, while next-generation sequencing techniques, such as short-read sequencing, can enable the ability to 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.
Andelyn’s key asset is our AAV production database allowing us to minimize the amount of optimization needed.
We focus on preclinical analytics during development in order to anticipate GMP 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 adherence to regulatory standards. Analytical development plays a pivotal role in addressing complex challenges ranging from assay variability to evolving regulatory expectations. Decades of experience and a deep understanding of the critical assays and analytics enable consistent delivery of safe, consistent and high-purity products.
Our analytical development services are supported at 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.
Method Validation
Method validation has been integral to our development and manufacturing processes. As we scale up to manufacturing operations, we meticulously adapt assays from the development stage to meet the rigorous standards of large-scale GMP production of both plasmids and viral vectors.
Our adaptive approach converts existing R&D assays but also creates new 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 and manufacturing phase production. These efforts not only maintain consistency in our material and processes but also ensure that our assays meet regulatory requirements and deliver reliable results throughout the manufacturing process.
Navigating Analytical Requirements for GMP Viral Vectors
The analytical requirements for viral vectors used to deliver gene therapies are complex and constantly evolving. Learn about the keys to success for establishing appropriate strategies.
Andelyn Development Center
Explore the heart of innovation at the Andelyn Development Center (ADC), where groundbreaking research, 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.