PROCESS DEVELOPMENT AND GMP MANUFACTURING
As cell therapies gain traction as a promising new therapeutic modality, emphasis is on robust and reliable scale-up to ensure their clinical and commercial success. Celonic offers expertise and capabilities in cell therapy development and manufacturing – from process development and optimization up to commercialization, including GMP manufacturing for human clinical trials.
Regulatory approval of two patient-derived cell therapies for hematologic malignancies marked the beginning of a new era for cancer and other hard-to-treat diseases. Such transformational cell therapies require a highly controlled production strategy combining single-use technologies with automation, process monitoring and control, to deliver consistent batches with high efficiency.
PRODUCTION PLATFORM SELECTION AND PROCESS DEVELOPMENT
Celonic’s extensive experience in process validation, process optimization and scale-up enable it to offer comprehensive cell therapy development services covering a wide range of cell types. Our cell therapy capabilities include:
- Adherent- and suspension-based cell processing
- Viral vector production and transduction for genetically engineered cell therapies
- Customized process development using flexible and project-specific equipment and instrumentation
- Closed processes with process automation provide cost-effective, consistent and robust scale-up
GMP MANUFACTURING
Celonic has provided biotherapeutic developers with the manufacture of their complex biologics for well over two decades. This expertise, combined with newly established processes and facilities for cell, as well as gene therapies, makes it possible for us to enable cell therapy innovators to serve broader patient populations.
Celonic continues to expand its existing cell and gene therapy production capabilities with an additional 90,000 ft2 state-of-the-art facility in Stein, Switzerland. Given the ever-evolving requirements of compliant cell therapy manufacturing, we offer developers maximum flexibility through tailored business models, flexible suite ownerships and rapid, modular facility expansion.
DRUG PRODUCT FILL AND FINISH
Celonic’s integrated, novel cell therapy offering includes Fill and Finish manufacturing services. Leveraging decades of experience in formulated-liquid drug product Fill and Finish, our team delivers GMP cell therapy product solutions for its clients.
ANALYTICAL METHOD DEVELOPMENT AND QUALITY CONTROL
Celonic’s analytical scientists understand the unique quality requirements of various cell therapies. Our team works in collaboration with its clients to develop tailored analytical methods and quality control (QC) testing solutions for our partner’s breakthrough cell therapies.
The analytical development and QC testing capabilities include:
Cell characterization and safety testing
Purity and potency testing
Release testing and characterization
LET’S GET STARTED
We understand what it takes to bring breakthrough cell therapies to patients in need.
Get in touch with our team.