Celonic’s 2021 Milestones – Looking Beyond the Pandemic
In 2021, we saw glimpses of a post-pandemic era coming into view with multiple vaccines approved and safely administered to millions around the world. For our team at Celonic, it has been a year of rising up to extraordinary challenges – adapting technologies and processes to develop and manufacture newer modalities like mRNA, bringing the new Heidelberg commercial manufacturing facility expansion into operation, and planning the expansion of our cell and gene therapy (CGT) capabilities at our new site in Stein, Switzerland.
Celonic’s latest offering – mRNA process development and GMP manufacturing
mRNA is a revolutionary therapeutic platform already changing the way we treat and prevent diseases. Its cost-effectiveness, ease of manufacture, and ability to target ‘yet-to-be-drugged’ pathways make it a unique modality capable of transforming the standard of care for many diseases. Celonic’s state-of-the-art modular mRNA GMP manufacturing facilities in Heidelberg and Stein comprise five production lines capable of producing up to a kilogram of mRNA. We offer GMP-compliant process development and scalable clinical to commercial manufacturing of mRNA drug substance (DS) for therapeutics and vaccines, complete with in-house analytical solutions.
State-of-the-art commercial facility in Heidelberg
In mid-2021, we expanded our commercial manufacturing capabilities by opening our newest facility at our Heidelberg site. The site offers more than 10,600 sqm with commercial manufacturing capacities of > 6,000 L. With this expansion, our Heidelberg facility is fully equipped to offer clinical and commercial manufacturing for biopharmaceuticals in phase III clinical trials or with regulatory approval.
Boosting our CGT services with an upcoming world-class facility in Stein, Switzerland
Earlier this year, Celonic announced a long-term lease agreement for a world-class production site and office space spanning 8,500 sqm at the Novartis-operated Life Science Park Rheintal in Stein, Switzerland. We will establish multiple modular independent production suites for mRNAs, viral vectors, cell therapies, and extracellular vesicles (EVs) to support clients from early clinical trials through commercialization. The facility will comprise 14 production lines, offices, and laboratories for process development, method development, quality control, and logistics.
With these major milestones achieved in 2021, Celonic is looking forward to a new year of continuing focus on excellence in delivering outstanding services to our clients and life-saving therapeutics to patients around the world.