A Framework for Automated Quality Assurance and Documentation for Pharma 4.0

Schmidt, Andreas; Frey, Joshua; Hillen, Daniel; Horbelt, J.; Schandar, Markus; Schneider, Daniel; Sorokos, Ioannis

doi:10.1007/978-3-030-83903-1_15

Cited by 7 publications

(5 citation statements)

References 15 publications

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“…5,6 One can also envision sophisticated ways of linking data supporting criticality assessments such that it can be readily and quickly retrieved. [7][8][9] As a result, ongoing learnings from investigations, additional experimentation, etc. may be included as part of the evolution of the design space.…”

Section: Discussionmentioning

confidence: 99%

“…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%

See 1 more Smart Citation

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%

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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“…Combined with AI applications, this allows real-time data to be analyzed, predictions to be made, and even parameter adjustments to be made automatically. This not only leads to higher process accuracy and productivity, but in the future can become the foundation for standardization and therefore also the driving force on the path to certification to meet regulatory guidelines for medical therapies or food products ( Li and Faulkner, 2017 ; Haeusner et al, 2021 ; Schmidt et al, 2021 ). Current studies predict, for instance, that clean meat could become part of the everyday diet in a few years ( Chriki and Hocquette, 2020 ; Lee et al, 2020 ).…”

Section: Discussionmentioning

confidence: 99%

Scalable Biofabrication: A Perspective on the Current State and Future Potentials of Process Automation in 3D-Bioprinting Applications

Lindner

Blaeser

2022

Front. Bioeng. Biotechnol.

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Biofabrication, specifically 3D-Bioprinting, has the potential to disruptively impact a wide range of future technological developments to improve human well-being. Organs-on-Chips could enable animal-free and individualized drug development, printed organs may help to overcome non-treatable diseases as well as deficiencies in donor organs and cultured meat may solve a worldwide environmental threat in factory farming. A high degree of manual labor in the laboratory in combination with little trained personnel leads to high costs and is along with strict regulations currently often a hindrance to the commercialization of technologies that have already been well researched. This paper therefore illustrates current developments in process automation in 3D-Bioprinting and provides a perspective on how the use of proven and new automation solutions can help to overcome regulatory and technological hurdles to achieve an economically scalable production.

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“…Aynı zamanda IoT cihazlarının medikal veri toplayarak tam zamanlı izleme katkı sunması sayesinde tedavi protokolleri hasta odaklı olarak güncellenebilir duruma gelecektir. Tüm bu nedenler göz önüne alındığında bireyselleştirilmiş tedavi kavramı Farma 4.0 uygulamaları ile mümkün kılınabilmektedir [72].…”

Section: Sonuç Ve Tartişmaunclassified

Farmasöti̇k Endüstri̇de Farma 4.0 Yaklaşimi

BEBEK,

AKDAG,

ÖNER

2023

Ankara Ecz. Fak. Derg.

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Amaç: Bu derlemede, teknolojideki gelişmelerin farmasötik endüstri bakış açısı ile değerlendirilmesi ve gelişen teknoloji ile ortaya çıkan Farma 4.0 yaklaşımının farmasötik üretim ve Ar-Ge alanlarına etkisinin tartışılması amaçlanmıştır. Sonuç ve Tartışma: Farmasötik endüstri, teknolojik gelişmelerin öncelikle uygulandığı en önemli endüstri alanlarından biridir. Bununla birlikte, kaliteli, etkili ve güvenli ilaç üretme gerekliliği çoğu zaman farmasötik endüstrinin teknolojik gelişmeleri eş zamanlı takibi açısından kısıtlayıcı bir etken olarak görülmüştür. İlaç üretiminde konvansiyonel sistemlerin kullanılması ile yaşanan zorluklar, ilaç üreticilerini kaçınılmaz olarak ve teknolojik gelişmeler doğrultusunda verimli alternatifler aramaya yöneltmiştir. Endüstri 4.0 kavramının ortaya çıkması ile bu yaklaşımın farmasötik endüstrideki uygulanabilirliği tartışılmaya başlanmıştır. Yapay zeka, nesnelerin interneti, makine öğrenimi ve bulut sistemler, Endüstri 4.0’ın temel bileşenlerini oluşturmaktadır. Veri ve deney tasarımlarının oldukça önemli olduğu ilaç keşfi ve formülasyon geliştirme alanlarında bu bileşenlerin kullanımı verimlilik, etkililik ve güvenlik açısından büyük bir potansiyele sahiptir. Endüstri 4.0 kavramının farmasötik alandaki karşılığı olarak tanımlanan Farma 4.0, verimliliği artırmasının yanında çevreci üretim sistemleri kurmayı da vadeden ve böylece sürdürülebilirliği destekleyen bir yaklaşımdır. Yeni endüstri devrimi ile tüm dünyanın büyük bir dönüşüm içerisine girdiği teknoloji çağında, farmasötik endüstrinin de bu gelişmelere en kısa sürede uyum sağlaması gerekmektedir.

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A Framework for Automated Quality Assurance and Documentation for Pharma 4.0

Cited by 7 publications

References 15 publications

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

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

Scalable Biofabrication: A Perspective on the Current State and Future Potentials of Process Automation in 3D-Bioprinting Applications

Farmasöti̇k Endüstri̇de Farma 4.0 Yaklaşimi

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