For the December issue of Life Science Leader, Natalie Holles, president and COO of Audentes Therapeutics, answered a question about the future of biopharma manufacturing by calling 2020 and beyond the “coming of age” for current Good Manufacturing Practice (cGMP) production for cell and gene therapies.
She continued, “As the field evolves toward unified best practices for production and purification systems, analytical methods and other elements of large-scale cGMP manufacturing, the development path for future cell and gene therapies will become smoother, faster and hopefully more successful, to the benefit of patients and families living with devastating diseases.” (Source)
Is the cell therapy community truly witnessing cGMP manufacturing come of age? Signs point to yes. For one, changes in the treatment approval process have had significant implications for cGMP standards.
With provisions for Fast Track, Accelerated Approval and other nontraditional drug and therapy approvals in the U.S. Food and Drug Administration’s (FDA) Federal Food, Drug and Cosmetic Act, immunotherapies that once required a dozen years from concept to FDA OK are now being approved in just a handful. The specificity of treatment techniques opens the doors for customized treatments for orphan diseases. Conditions such as retinal pigmentosa and blood and skin diseases, once incurable, are now able to be treated by recent advances in cell therapy. The approvals are only coming more quickly; just look at last winter’s fast-track approvals of treatments for sickle cell disease and mantle cell lymphoma.
But the recent enormous advances that may make these conditions a burden of the past haven’t slackened the cGMP requirements biopharma manufacturers need to meet and document to ensure validation and certification. Working against the clock for approval means that documentation needs to be produced and codified faster than even a few years ago, when the cGMP standards were developed.
If you’re a small lab vying for grants to keep your work going, the stakes can be even higher.
Thermo Fisher recognizes the enormous pressure researchers face in both maintaining their adherence to cGMP standards and producing documentation ensuring that products are safe, pure and effective. Because of this, we partner with biopharma manufacturers to guide them through meeting and maintaining compliance with standards. Our proven performance in critical operations for cell culture, separation and beyond helps researchers confidently expand their ability to start up rapidly.
Here are a few ways Thermo Fisher focuses on simplifying cGMP compliance:
- Our equipment throughout the workflow is manufactured within an ISO 13485 environment for reliability and includes IQ/OQ documentation to support rigorous validation.
- Recent enhancements to our equipment improve cleanability and ease of use to better fit with cGMP standards and clean-room demands.
- We offer field compliance services in all geographies with trained service team members to ensure rapid startup, including installation setup and connections.
- We offer temperature mapping to support PQ and record keeping as well as field calibration for CO2 temperature and RH. Temperature Mapping Reports and Calibration Certificates are available.
We agree that cGMP manufacturing is coming of age. Thermo Fisher Scientific will continue to support and guide our customers as they meet these critical standards to ensure the safety, effectiveness and success of their work.