Tailored Manufacturing for Advanced Therapies
Cell and Gene Therapy represents a new paradigm in human health. It has the potential to resolve unmet medical needs and improve patients’ lives through effective and safe Advanced Therapeutic Medicinal Products (ATMPs).
Celonic, as a premium quality-driven biopharmaceutical CDMO, is now entering into the Cell and Gene Therapy services space. We are taking a key strategic step within this fast-growing industry by developing and commercializing Cell Therapy and Gene Therapy Products.
Celonic is currently building a state-of-the art GMP Manufacturing Facility for Gene Vectors and Cell Therapy at our site in Basel. We will offer capacities ranging from Process Development and Optimization up to early-commercialization, including Clinical Trial Manufacturing for Phase I, II and III.
Our Gene Vectors Services:
- Gene Vector Formulation Development*
- Process Development, Validation, Optimization and Scale-up
- Cell Line Development and Optimization
- Assay Development and Validation
- Analytical Services
- Regulatory Affairs Services*
- GMP Manufacturing: AAV, Lentiviral, Retroviral
- Aseptic Fill and Finish
- Storage and Logistics
* In collaboration with our sister company, ProJect Pharmaceutics GmbH
Tailored formulation development services for gene vectors
Streamlined stabilization concepts in formulation and process gateway which are optimized for maintained virus activity during long-term storage.
Formulation and lyophilization process development for live virus vaccines
Viral vectors widely used for gene transfer in e.g. cell and gene therapy, are a class of biologics of high structural complexity. Maintaining the native quaternary structure of the virus capsid and avoiding virus aggregation is key the for the virus to retain its full biological activity, even when exposed to stressful conditions prior to and during manufacturing. Therefore, streamlined stabilization concepts are required.
Celonic, in collaboration with ProJect Pharmaceutics GmbH, gateways the development of guideline-conforming quality-by-design based formulation and stabilization concepts. We use analytical high-throughput stability predictive technologies, virus forced degradation, thermal characterization, accelerated stability and definition of design space by process robustness testing.
The use of optimized formulations and dedicated pilot freeze dryers enables the design of tailored lyophilization cycles, both maximally robust and efficient, in order to maintain virus activity for safe distribution of viral vectors during long-term storage.
A deep understanding of the challenges when processing virus vaccines enables the development of smart formulations and manufacturing processes and thus safeguard the efficacy of the finished product and provide specific solutions for this group of highly complex products.