Knowledge Management in Support of QbD

Joglekar, Girish; Reklaitis, Gintaras V.; Giridhar, Arun; Mockus, Linas

doi:10.1002/9781119356189.ch14

Cited by 2 publications

(1 citation statement)

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“…The QMS associated with ICB is expected to evolve to accommodate multi‐variate design space for detection and management of deviations to allow more flexible operations within a non‐orthogonal combination of CPP acceptable ranges 5,6 . One can also envision sophisticated ways of linking data supporting criticality assessments such that it can be readily and quickly retrieved 7–9 . As a result, ongoing learnings from investigations, additional experimentation, etc.…”

Section: Discussionmentioning

confidence: 99%

Managing integrated continuous bioprocesses in real time: Deviations in product quality

Grampp,

Bosley,

Qadan

et al. 2023

Biotechnology Progress

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The N‐mAb case study was produced by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to support teaching and learning for both industry and regulators around adoption of advanced manufacturing process technologies such as integrated continuous bioprocesses (ICB) for monoclonal antibodies (mAbs). N‐mAb presents the evolution of an integrated control strategy, from early clinical through process validation and commercial manufacturing with a focus on elements that are unique to ICB. The entire N‐mAb case study is quite comprehensive, therefore this publication presents a summary of the chapter on managing deviations from a state of control in real time. This topic is of critical importance to ICB and is also applicable to batch processes operated at a rapid cadence.

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Section: Discussionmentioning

confidence: 99%