CLINICAL SUPPLY MANUFACTURING ARTICLES

Bacteriophage Virus Cycle-GettyImages-1784637244 Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development

The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

CLINICAL SUPPLY MANUFACTURING VIDEOS

If you are in the process of developing a complex or sensitive injectable drug, learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.

Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.

Christina Yi, Chief Operating Officer at Vaxxinity, vaccine commecialization expert Kimberly Murphy, and Valneva Chief Medical Officer Dr. Juan Carlos Jaramillo discuss the biggest manufacturing challenges they face as they work quickly to develop clinical supply of next-generation vaccines and commercial supply of existing product. The supply chain proves chief among those challenges. In this segment of our recent BioProcess Online Live! event Manufacturing Vaccines On COVID's Coattails, the two discuss how these challenges have impacted timelines, how they're solving those challenges at Vaxxinity and Valneva, and lessons learned during the COVID-19 pandemic that they'll carry into the future.

Susan Dexter, Chief Technical Officer, Sonnet BioTherapeutics, describes the good choices she made, and one not-so-good choice, in trying to untie a knotted supply chain.

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