Cell and Gene Regulatory
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Jumpstart Your QMSR Transition: Get Ahead Of Evolving Regulations
5/16/2024
Join industry experts as they guide you through your transition to the QMSR, discussing key changes and impact from new requirements, ensuring that your company achieves compliance.
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Enhancing Development And Mitigating Challenges With Plasmid DNA
5/13/2024
Plasmids, essential in biologics manufacturing, pose challenges in their development and scale-up due to difficulties integrating and optimizing them with the appropriate cell lines during process development.
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Examining A Phase 1 COVID-19 Clinical Trial
5/10/2024
Uncover how we were able to efficiently activate the site and enroll 130 participants within six months, demonstrating our expertise in clinical trial management.
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Emulate Endorses The FDA Modernization Act Of 2021
5/10/2024
Learn why removing the mandate for animal testing would enable faster, more efficient, and more humane drug development, all while benefiting both patients and the pharmaceutical industry.
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Global Regulatory Excellence Throughout The Clinical Development Lifecycle
5/8/2024
Navigating the intricate global regulatory path is crucial for clinical development success. See how expert-backed support has consistently propelled sponsors toward regulatory excellence.
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Best Practices To Adapt And Improve Quality Control Programs For CGTs
5/8/2024
Cell and gene therapies require adaptive and advanced assays for characterization and safety assessments; in many instances, the assays historically used for biologics must diversify to accommodate them.
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Strategically Design Your Quality Control Toolkit To Better Mitigate Risk
5/8/2024
If you’re hoping to improve your QC toolkit to better accommodate complex modalities like CGTs, its time to build a program that accounts for risk and unique product characteristics.
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Overcome The Challenges Of Designing A QC Program For New Modalities
5/8/2024
Stringent QC release testing throughout biologic production, as mandated by global health authorities, ensures product safety and quality through robust evaluations of identity, purity, potency, and critical quality attributes.
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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.