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Recently, the European Medicines Agency (EMA) took the lead in pushing for processimprovements using technologies already established in other manufacturing sectors. Nanoparticle HIV vaccine shows potential in trial Nanomedicines generally require aseptic processing. Yet in 2021, 100 nanomedicines had been marketed.
3 (2022):593–607. October 2022. Blood 140, supplement 1 (2022):10323–24. 5 October 2022. PDA Journal of Pharmaceutical Science and Technology 75, no. 1 (2021):48. 3 a b c Algorri, M., Re-Envisioning Pharmaceutical Manufacturing: Increasing Agility for Global Patient Access.” Journal of Pharmaceutical Sciences 111, no.
Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. HC is expected to have full implementation of ICH Q12 by late 2022. Reader note: This article was initially submitted to Pharmaceutical Engineering® during December 2021/January 2022. Streamlining Postapproval Submissions Using ICH Q12 & SCDM.
Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 2022. Reader note: This article was originally submitted to Pharmaceutical Engineering® in January 2022. 5 (May 2022): 1232–1244. Trudy Patterson. Regulatory Landscape for Raw Materials: CMC Considerations. Jacqueline E. Milne, PhD. Cauchon, PhD.
For Jamaels, whose track record in managing complex operations and delivering processimprovements spans GSK Vaccines and one of the world’s largest companies, GE, the technological shift is an exciting development: “I’m passionate about the digital transformation that our industry is going through,” he says.
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