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Oct 7, 2024 | 
outsourcedpharma.com | Matthew Pillar |Irwin Hirsh |Q-Specialists AB |Louis Garguilo
Breaking Barriers: Combining Cell Line Development Innovation with Improved Process Development Workflows to Streamline Path to FIHThis webinar will focus on how KBI Biopharma's SUREtechnology Platform™, powered by Selexis®, enables rapid advancement of new complex biologics from early development to first-in-human (FIH). Register to learn how the integration of the SUREtechnology Platform™ accelerates the creation of high-performing, stable cell lines tailored for biologics production.
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Sep 30, 2024 | 
cellandgene.com | Irwin Hirsh |Q-Specialists AB |Joonman Hong |GC Cell
Reserve your space for our Virtual Symposium on October 08! Moderated by Dr. Eleni Samaridou, Principal Scientist, Early Formulation Screening Service at MilliporeSigma, the symposium will feature Dr. Roland Böttger, Senior Scientist at CureVac, and other industry experts.
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Sep 27, 2024 | 
bioprocessonline.com | Irwin Hirsh |Q-Specialists AB
By Irwin Hirsh, Q-Specialists AB
Part one of this article explored the rationale behind establishing a team structure for CMC development based on the writings of Matthew Skelton and Manuel Pais in their 2019 book Team Topologies. There I explored the types of cognitive load — intrinsic, extraneous, and germane — and how a clear division of duties helps to ensure the right teams are bearing the right loads to maximize efficiency.
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Sep 20, 2024 | 
bioprocessonline.com | Irwin Hirsh |Q-Specialists AB
By Irwin Hirsh, Q-Specialists AB
In their book Team Topologies, Matthew Skelton and Manuel Pais apply the educational concepts of cognitive load proposed by Sweller1,2 and generate a methodology for the creation of balanced and productive teams of software developers. Perhaps not surprisingly, these approaches to development teams map well to knowledge workers such as CMC development scientists.
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Sep 20, 2024 | 
biosimilardevelopment.com | Irwin Hirsh |Q-Specialists AB
By Irwin Hirsh, Q-Specialists AB
In their book Team Topologies, Matthew Skelton and Manuel Pais apply the educational concepts of cognitive load proposed by Sweller1,2 and generate a methodology for the creation of balanced and productive teams of software developers. Perhaps not surprisingly, these approaches to development teams map well to knowledge workers such as CMC development scientists.
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Aug 10, 2024 | 
cellandgene.com | Mark Witcher |Q-Specialists AB |Irwin Hirsh |Anthony Stewart
Hello Cell & Gene readers,I'm happy to bring you July's most-clicked articles. Enjoy!Erin Harris, editor-in-chief Follow me on XJULY'S BEST FEATURED EDITORIALSystem Failure Mode & Effects Analysis: Intuitive Risk AnalysisYour company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.
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Jul 17, 2024 | 
outsourcedpharma.com | Irwin Hirsh |Q-Specialists AB |Louis Garguilo
What's your development and manufacturing outsourcing strategy based on? Do you have the right contracts and external relationships in place to successfully implement that strategy? Are there new models for sponsor-CDMO partnerships? Join Outsourced Pharma Live on August 13th as our panel of professionals will provide personal analysis and ideas for determining how you might best conduct your development and manufacturing activities, outsourcing business models, and external relationships.
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Jul 10, 2024 | 
pharmaceuticalonline.com | Irwin Hirsh |Q-Specialists AB
By Irwin Hirsh, Q-Specialists AB
Knowledge workers often resist following standard work, arguing that it stifles productivity and hampers the creative process integral to their roles. However, standard work can significantly enhance productivity and creativity by reducing cognitive load and automating routine tasks. This article discusses the benefits of standard work for knowledge workers, drawing from personal experience and supported by scientific literature.
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May 14, 2024 | 
pharmaceuticalonline.com | Irwin Hirsh |Q-Specialists AB |Grant Merrill |Carol Houts
Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs. An Introduction To Laminar Airflow Technology In Aseptic ProcessingExplore the vital role that laminar airflow technology plays in meeting sterile integrity standards and minimizing contamination risks in pharmaceutical cleanrooms.
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Apr 25, 2024 | 
bioprocessonline.com | Irwin Hirsh |Q-Specialists AB |Matthew Pillar |Geraldine Carr-Mulry
Webinar: Addressing The Options And Challenges In Subvisible Particulate Contamination Monitoring In Single UseJoin us for a webinar on May 16th with Entegris! Particulate contamination in pharmaceutical and biopharmaceutical products produced using single-use systems can create detrimental health risks that are required to be minimized by regulatory agencies. This contamination can be divided into visible and subvisible ranges, both ranges of particles are tested using different techniques.
