To say that the cell therapy market is exciting may be an understatement. Sophisticated cell therapies can propel a manufacturer to great success, significantly improve a patient’s health and quality of life, and even usher in a beneficial paradigm shift in the approach to healthcare.
These aspirations are noble indeed, but to transition abstract notions into quantifiable, commercialized realities– especially when using complex and often fickle cells – requires a concrete strategy. This is where Quality by Design (QbD) principles are highly relevant. The U.S. Food and Drug Administration (FDA) encourages use of these principles as a framework to guide plans when progressing cell therapies from research to production scale and commercialization.
QbD is encapsulated as the combination of deep product knowledge, process control, and risk mitigation to ensure consistent and high quality. These principles may be applied whether for allogenic therapies that rely on scale up to mass produce a single cell type for treating multiple patients, or for autologous therapies that utilize a scale out with small cell batches manufactured for individual patients. Additionally, QbD integrates well with detailed current good manufacturing practice (cGMP) requirements and other regulatory guidelines.
While planning and scaling for commercialization using QbD principles can seem as complex and multi-faceted as a cell’s behavior and phenotype, you are not alone.Thermo Scientific™ offers cell therapy solutions that apply QbD principles and adhere to cGMP standards for use in your cell therapy workflow. In addition to advanced features that support cell and gene therapy needs, this laboratory equipment comes with tools to minimize the precious time you spend on scaling challenges while remaining compliant with regulatory requirements.
- Forma™ Steri-Cult™ CO2 Incubators – CTS Series combine high volume culturing and ultimate contamination control with factory acceptance testing (FAT) and IQ/OQ documentation critical to validation along with field service
- HeraSafe 2030i Biological Safety Cabinets – CTS Series maximize sample protection and user safety; and a comprehensive, time-saving validation package supports your peace of mind
- Sorvall™ X4 R Pro Centrifuges – CTS Series are an essential separation tool for today’s rapid-fire discoveries, while FAT documentation and validation services get you up and running fast.
- CryoMed™ Controlled-Rate Freezers – CTS Series* offer a patented LN2 delivery system to deftly prepare cell and gene therapy products for ultra-cold and cryopreservation storage.
The cell therapy commercialization process, including application of QbD principles, doesn’t have to be daunting. In fact, it can be made easier by relying on cell therapy solutions and expert advice from ThermoScientific. Careful planning now eases the path from research through production and commercialization so that you can make a noble difference in the world.
*Availability: CTS series only in North America, standard model world-wide.