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By Geneviève Michaux and Georgios Symeonidis, King & Spalding, Brussels | In the EU, national health technology assessment bodies generally aren't so well equipped to address novel and complex medicinal products. That makes the EMA's interim parallel scientific advice program especially useful for biologic drug developers completing market authorization activities in EU member states. |
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Akamis Bio Takes On Advanced Solid Tumors | By Erin Harris, Editor-In-Chief, Cell & Gene | Akamis Bio’s CEO, Dr. Howard Davis, explains the company's T-SIGn platform, the NG-350A trial, and how T-SIGn may impact CAR-T for solid tumors. |
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| Realizing A New Approach To Allogeneic Cell Therapy Process Development | Article | By Sara Miller and Marie-Caline Abadjian, FUJIFILM Diosynth Biotechnologies | By standardizing the cell therapy process and common tools across both allogeneic and autologous applications, operators can enable greater speed and reduce the potential for error during the process. |
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| Why cGMP Chemicals And Single-Use Technologies Are Critical | Article | By Tim Korwan and Wayne Lynch, Avantor | Ensuring transformative medicines make it to patients in need requires risk mitigation strategies that improve the quality of raw materials while facilitating scale-up processes to meet global demand. |
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| Suspension Cell Culture In Cell And Gene Therapy | Article | By Cyrill Kellerhals, Andelyn Biosciences | Adaptability is crucial for developers as they upscale the production of viral vectors. Explore the benefits of using suspension cell lines and why adherent cell culture shouldn’t be left behind. |
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| How To Improve Resiliency In The Medical Device Supply Chain | White Paper | By Paul Priebe, Qosina Corporation | Explore how to select the right partner in the medical device supply industry to avoid supply chain breakdowns in product quality, delivery, or availability that could endanger patient health. |
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| Critical Considerations For Buffer Preparation | White Paper | By William Whitford, Thermo Fisher Scientific Bioproduction | When optimizing your organization's buffer use, learn about the steps of buffer development, choosing a supply approach and strategy, choosing between in-house and outsourcing buffer activities, and more. |
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| The Future Of Plasmid DNA Upstream Optimization | Article | AGC Biologics | An optimized upstream manufacturing process is crucial for producing the necessary amount of plasmid DNA required for the growing number of therapeutic and vaccine applications available. |
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| Move Your Gene Therapy From Strategy To Reality | Article | Cytiva | Implementing integrated solutions can provide cell and gene therapy manufacturing systems that work in concert to create a closed, automated, scalable, and performance-qualified network of unit operations. |
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