PROCESS DEVELOPMENT AND GMP MANUFACTURING
Emerging cell and gene therapies require streamlining of viral vector development, production and processing to unlock their full potential. Celonic now provides expertise and capabilities in process development, scale-up and analytical method development for GMP and non-GMP viral vectors production.
Viral-vector-based gene therapies give patients with inherited single-gene defects, cancers and other previously untreatable diseases new options for safe and effective treatment. A number of cell and gene therapies have successfully moved from bench to bedside, thanks to considerable improvements in efficacy and safety. Scalable, cost-effective and compliant manufacturing will drive continued success of these advanced therapies.
Leveraging its more than two decades of experience in GMP manufacturing, Celonic supports clients from early phase clinical development through to commercial-scale manufacturing of viral vectors.
Our state-of-the-art viral vector capabilities include:
- Diverse viral vector and cell line platforms
- Multi-scale, high-throughput transient cell line transfection
- Adherent- and suspension-based USP development
- Flexible and project-specific equipment for DSP development
- Comprehensive analytical development