CDMO Cell and Gene Therapy Solution
Process and Analytical Development, Tech Transfer, Quality Control, GMP Manufacturing and Product Release
Our facility provides end-to-end, versatile services, enabling small to large scale production, all within a single location.
Process and Analytical Development, Scale up and Industrialisation
CELLforCURE by SEQENS development team works hand in hand with R&D customer teams to bring processes and analytics to GMP sustainable standard.
CELLforCURE by SEQENS CMC approach includes :
CELLforCURE by SEQENS development team welcomes R&D customer team on site to strengthen collaboration.
CELLforCURE by SEQENS development lab is designed to facilitate transition to GMP manufacturing lines.
CELLforCURE by SEQENS CMC approach includes :
- Process scale up
- Equipment testing and qualification
- Key quality attribute definition and qualification
- IND and regulatory submission support
CELLforCURE by SEQENS development team welcomes R&D customer team on site to strengthen collaboration.
CELLforCURE by SEQENS development lab is designed to facilitate transition to GMP manufacturing lines.
Technology Transfer Strategy
CELLforCURE by SEQENS “One Stop Shop” approach delivers significant efficiency gains and operational synergies, aiming at ensuring strong reliability and time saving.
Enhanced training and expertise of the project team ensure consistency and reliability, with the goal of accelerating the transfer time.
- Same equipment in both Development and GMP areas
- One single team handles projects from Tech Transfer to GMP production
Enhanced training and expertise of the project team ensure consistency and reliability, with the goal of accelerating the transfer time.
Extensive internalization of Quality Control for optimal reliability and speed
CELLforCURE by SEQENS is equipped with state-of-the-art equipment allowing for a wide range of in-house controls for raw materials, starting products, intermediates, and finished products.
- In-process controls, such as cell counts, phenotypes
- Environmental monitoring sampling and analysis (particulate and microbiological)
- Release testing : sterility, identity, purity and potency