Stand A1
DINAMIQS is an established European CDMO whose core business is focused on the manufacturing of AAV gene therapy vectors.
We provide a comprehensive and integrated range of services:
- Process development trough scalable upstream and robust purification processes
- Manufacturing
- Analytical development and quality control testing
Our 2 facilities are located in Schlieren-Zurich Bio-Technopark, Switzerland: A Fully operational state-of-the-art R&D facility (13,000 sq ft) dedicated to process development, manufacturing up to 50L scale and analytical testing. A 2*500L scale GMP facility (26,000 sq ft) is currently being fitted out.
Our team brings decades of development, adaptation of processes to large-scale bioreactor systems and manufacturing expertise on a variety of AAV serotypes, including novel engineered capsids, to customize your program and fulfill your in vitro and in vivo needs.
Our manufacturing platform is based on transient transfection of HEK293 cells, followed by customized state-of-the-art upstream and downstream processes. Based on our experience in developing scalable manufacturing processes for multiple AAV products, we are aiming to be a strong, collaborative partner proposing customized development and manufacturing program such as:
- Technology transfer (if needed)
- Manufacturing at flask scale
- Transition development in 2L-4L scale bioreactors. This step allows to collect initial yield and purity data specific to the construct. Potential upstream and downstream process development are identified for future scale-up
- Optimization of upstream process
- Selection and optimization of downstream process
- Formulation of drug product (DP)
- Scale-up-up development in 50L bioreactors based on previous stages. The material supplied can be used to complete research studies and perform preclinical studies such as GLP-compliant toxicology-biodistribution studies
- Implementation of assays and quality control testing required for release of batches
Aligned with GMP regulations, our manufacturing approaches will provide your research with high quality vectors and minimal changes moving forward to your clinical applications. This de-risk and accelerate timelines to produce your clinical material, reducing the time from gene to clinic.
Each of your projects will benefit from a designated project manager and a cross-functional team of technical and scientific experts with defined roles to effectively meet your objectives.
