ISPE
SEPTEMBER 11, 2023
POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. 2 October 2019. Meet Eli Lilly and Company - 2019 Facility of the Year Process Innovation Category Winner.” 11 September 2019. 6 November 2019. Aseptic Processing: A Vision of the Future.”
ISPE
MARCH 29, 2023
Published November 2019. link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. [link] 3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
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ISPE
MARCH 29, 2023
Published November 2019. link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. [link] 3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
ISPE
OCTOBER 27, 2022
Oligos generally have excellent stability in aqueous solutions, and lyophilized oligos are dissolved in aqueous formulation buffers for preparation of the final dosage form anyway. ChromaCon 2019. Unfortunately, lyophilization is energy intensive and time consuming, often requiring 3 to 5 days to complete a batch. 8 Wetter, C.,
ISPE
AUGUST 30, 2022
In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.
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