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By Irwin Hirsh, Q-Specialists AB | In this practical guide for adding oversight, based on a hierarchy of metrics, optimize quality agreements to transform them into living, metrics-driven control instruments for your operation. | |
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| FDA's Regenerative Medicine Advanced Therapy (RMAT) Program | White Paper | By Isaiah Manoogian, Pace® Life Sciences | RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review. |
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| Challenges In LVV Purification And Quantitation | Article | By Poorni Adikaram, Ph.D., Tyler Frazier, et al., Ascend & ABL Inc. | Hear about how this company is overcoming purification challenges and advancing scalable, GMP-ready lentiviral vector manufacturing for gene and cell therapies. |
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| Viral Vectors: The Backbone Of Cell And Gene Therapy | Article | Landmark Bio | Viral vectors are the indispensable backbone of genetic medicine. Read about the fundamental trade-offs and manufacturing strategies for large-scale production of AAV and lentiviral delivery systems. |
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| Analytical Approach For Bispecific Antibody Quality Study | White Paper | ProBio | Bispecific antibody quality control demands advanced analytics to detect mispaired species, assess structural integrity, and confirm potency, ensuring safety and efficacy across diverse therapeutic applications. |
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