In today’s landscape, gene therapy offers us the broadest potential for novel medicines. Many challenges await to be uncovered on the journey to the clinic, from DNA, mRNA and microRNA to vaccine approaches to viral vector production and testing. At Eurofins Discovery, we are proud to cover the full spectrum of drug discovery research support, from early discovery through manufacturing support — allowing you to focus on critical innovations.
Our gene therapy specialists have navigated gene therapy IND submissions themselves, providing you with their experience and success in plasmid creation, transfection, small-scale viral particle production and quality control, and infectivity testing expertise that will put you on the critical path to the clinic.
At Eurofins Discovery, not only can we provide the extra hands behind the bench, our scientists help you assess cellular effects of direct nucleic acid therapeutics at all levels of cell physiology, ensuring the greatest chance of success. Once your biotherapeutic development is further along, our validated and qualified cGMP partners in the greater Eurofins Scientific network seamlessly transitions your assets and protocols into manufacturing and pre-clinical development. Whether your interests lie in allogeneic or autologous approaches choose from our wide array of ready-to-use assays and services or speak to a gene therapy discovery specialist to design a custom solution.
Custom Lab-scale AAV Viral Particle Production On-Demand
Adeno-associated viral (AAV) particles have become a vehicle-of-choice for many of today’s gene therapeutic approaches. As AAVs are not known to be responsible for any human pathologies, they are considered to be very safe options as gene delivery vehicles. AAV characteristics include extremely simple molecular biology that make it easy and efficient to insert target transgenes into their genomes. For plasmid design and creation, Eurofins Discovery will help you with custom synthesis and transfection into lab-scale production of AAV particle stocks and banking – readily accessible, well characterized, and quality controlled until you are ready to scale up into cGMP manufacturing.
Whether you have a plasmid ready to transition to viral particle production or need a custom plasmid designed, Eurofins Discovery is your complete solutions partner to collaborate to help you create one. Explore our qualified and validated partners for seamless technology transfer from a non-GLP to a cGMP environment.
AAV Particle Characterization and Qualification
Adeno-associated virus (AAV) particles have become a delivery system of choice for the gene therapy field due to their safety and simple natures. AAVs are also easy to load with your genetic payload and produce in bulk. However, even with such a simple system for gene delivery, problems can arise. Eurofins Discovery gene therapy specialists have the expertise to anticipate those challenges before they become problems.
Our successful method focuses powerful dynamic light scattering (DLS ), static light scattering (SLS ), and UV/vis technologies on tiny subsets of your viral particle samples. This enables our scientific experts to give you rapid information on capsid titers, capsid sizes, full/empty capsid ratios, any aggregation issues which might be present, and total protein and ssDNA concentrations. And our method ensures that your viral particle passes the test for development with a viral particle stability assessment measuring temperature, pH, and AAV tropisms in vitro. Contact our experts to learn more about viral targeting.
| Key Characterizations for Viral Particles | Description |
|---|---|
| Biophysical Characterization of AAV Particles | Particle size assessments, empty/full capsid determinations, nucleic acid and protein quantification |
| AAV Batch Assessments of Aggregation | Monitor viral particle aggregations on a batch-by-batch basis |
| AAV Stability Testing | Assess AAV particle stability under varying conditions of temperature, pHs, and different buffers |
| AAV Buffer Exchange | Ultra-efficient buffer exchanges into physiologically relevant buffers |
| AAV Targeting Verification | Test AAV viral particle cell-specific infectivities to ensure proper targeting |
Seamlessly Transition from Discovery to Development with Downstream cGMP
From discovery to development, we are with you every step of the way at Eurofins Discovery. Whether you need a custom assay developed and transferred to your manufacturer, or are looking for a cGMP facility to seamlessly transition your program, our contract research organization (CRO) provides a global network of qualified and validated partners to support you.
Among the benefits of utilizing our CRO is having an experienced team to help connect you to our own cGMP support teams, or to work with your choice of providers to accomplish technology transfer of any SOPs, protocols, or assays we have developed for you. We want to ensure that you have a seamless transition from the pre-clinical to clinical stages. Your success is our success! Connect with an expert to learn more.
