Cell and Gene Regulatory
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Treating Alzheimer's With NK Cell Therapy
5/8/2024
I met with NKGen Biotech's CEO, Dr. Paul Song, MD, to learn how a serendipitous discovery shifted the company's clinical focus from cancer to Alzheimer's disease.
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21 CFR Part 11 Compliance Checklist For A Universal Pump
5/7/2024
This checklist provides a detailed look at the requirements of 21 CFR Part 11 and highlights how the Sterisart® Universal | Gen 4 - Advanced supports your efforts to meet these regulatory demands.
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Sterility Testing For A Connected Era
5/7/2024
This pump combines state-of-the-art hardware with sophisticated, user-friendly software to offer compliant, paperless documentation and reporting.
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Advancing Cell Therapy Manufacturing: Rapid Sterility Testing
5/7/2024
The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.
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Defining the CMC / Clinical Relationship for Allogeneic Cell Therapies
5/6/2024
During this segment, Nguyen and Wagner define why the relationship between CMC and Clinical is so critical, and they also explain what a mutually beneficial partnership between CMC and Clinical looks like.
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Best Practices for Effective Donor Management
5/6/2024
Starting with high quality donor material is critical for allogeneic cell therapy drug manufacturing, and this requires laying the groundwork for a high-touch, end-to-end donor pool management strategy.
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Major Trends Impacting Allogeneic Cell Therapies for Oncology
5/6/2024
We kicked off this Cell & Gene Live, Unlocking the Future of Allogeneic Cell Therapy for Oncology by discussing the major trends impacting allogeneic cell therapies for oncology.
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Annex 21 – Are We On Track And Is There An Impact?
5/6/2024
What does Annex 21 entail, what makes the process of meeting the requirements so complex and time-consuming, and has Annex 21 inadvertently created additional barriers to supply.
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Translating Study Reports – A GLP Draft Guidance
5/6/2024
The FDA has provided guidelines for the translation of studies conducted by non-US testing facilities, including an expectation that the translated report include a statement of certification requirements.
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FDA’s Advanced Manufacturing Technology Program
5/6/2024
Learn about a new Advanced Manufacturing Technologies (AMT) Designation program aimed at accelerating the implementation of technologies that drive speed to patient and enhanced sustainability.