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By Guriqbal Singh, RegWeb | This overview describes the patchwork regulations for biosimilar developers in the Middle East and North Africa. These countries are among the most active in the world for biosimilar drugs. |
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| Standardization And Flexibility In Aseptic Filling | Article | Cytiva | Standardization and flexibility in aseptic filling were thought to be mutually exclusive. But what if there was a standardized system with flexibility built into the aseptic process, so you didn’t have to choose? |
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| Designing Successful Viral Clearance Studies | White Paper | By K. Martin Remington, and K. Smith, MilliporeSigma Biosafety Testing Services | We review studies that involve scaling down individual process steps, and, for each step, spiking virus into the specific process intermediate, performing the process step, and measuring the remaining virus. |
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| Mitigating Particulate Risk In Injectables | Article | By Tibor Hlobik and Ravi Patel, West Pharmaceutical Services, Inc. | Learn about the sources of particulates in injectables and how manufacturers should apply the latest regulations to ensure best practices when producing sterile drug products. |
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