On-Line Monitoring of Vacuum Dryers Using Mass Spectrometry

Ende, David J. am; Preigh, Michael J.; Hettenbach, Kevin; Ahlijanian, Paul; Ward, Howard W.

doi:10.1021/op000205s

Cited by 14 publications

(10 citation statements)

References 2 publications

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“…This is demonstrated in a review article on typical applications of MS in process analysis [64]. The application of MS or MS-MS techniques in process monitoring has already begun [65]. It is, moreover, to be expected that the number of applications will further increase when equipment prices are reduced.…”

Section: Process Analytical Techniques/process Analysismentioning

confidence: 99%

New Developments in Chemical Engineering for the Production of Drug Substances

Behr

Brehme

Ewers³

et al. 2004

Engineering in Life Sciences

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The pharmaceutical industry is moving towards a profitability gap between increasing costs and decreasing prices. Finally, management has understood that mergers and acquisitions, high throughput screening, and biotechnology alone will not save the companies' earnings. Therefore, classical approaches like the optimization of production technologies for drug substances, that might help to increase profitability, are receiving increasing attention. This paper shows how the combination of innovative components will guide the way to very efficient and cost-effective production. The first component is the design and manufacturing of production facilities. The second component is a process streamlining of the production process. The key technologies discussed here are process control and miniplant technology. For these technologies a brief outlook on future trends is given.

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Section: Process Analytical Techniques/process Analysismentioning

confidence: 99%

New Developments in Chemical Engineering for the Production of Drug Substances

Behr

Brehme

Ewers³

et al. 2004

Engineering in Life Sciences

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show abstract

“…Die Geräte werden kleiner, wartungs-und bedienungsfreundlicher und letztlich auch kostengünstiger, wie ein Übersichtsartikel zu typischen Applikationen der MS in der Prozessanalytik zeigt [64]. Der Einsatz der MS-oder MS/MS-Techniken im Prozessmonitoring hat schon begonnen [65]. Es ist zudem zu erwarten, das die Anzahl der Applikationen mit sinkenden Gerätepreisen weiter zunimmt.…”

Section: Prozessanalysentechnik/prozessanalytikunclassified

Neue Entwicklungen bei Anlagen und Verfahren für die Produktion von Pharmawirkstoffen

Behr

Brehme

Ewers³

et al. 2003

Chemie Ingenieur Technik

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Die Pharmaindustrie befindet sich auf dem Weg in die Kostenfalle. Mehr und mehr setzt sich die Erkenntnis durch, dass klassische Stärken der Optimierung von Produktionstechnologien dort ansetzen können, wo Fusionen, Investitionen in High‐Through‐Put‐Screening und Biotechnologie bisher nicht die nötigen Erfolge gezeigt haben. Im vorliegenden Beitrag wird gezeigt, wie aus einer Kombination von innovativen Bausteinen eine leistungsfähige und deutlich kostengünstigere Produktion von Pharmawirkstoffen resultiert. Diese kann den Ausweg aus der Kostenfalle weisen. Ein erster Baustein, der betrachtet werden soll, ist der Anlagenbau, daneben ist eine deutlich stärkere Prozessorientierung als zweiter Baustein zu sehen. Die Technologien, die den dritten Baustein der neuen Produktionswege für Pharmawirkstoffe darstellen, sind die Miniplant‐Technologie und die Prozessanalytik. Zu letzterem technologischen Baustein werden anhand von Beispielen die Trends der Zukunft aufgezeigt.

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“…In situ analytics may be used throughout the pharmaceutical development lifecycle. − These tools are regularly used during discovery, preclinical, and early clinical phases for process development and process understanding. The value of applying the tools and how the tools are used can vary significantly as the program develops through the clinical phases and to commercial manufacturing, as detailed in the previous section.…”

Section: Introductionmentioning

confidence: 99%

“…By monitoring these specific functional groups, qualitative trending or quantitative assessment of the reaction component(s) levels is achieved. In situ chromatography, , mass spectrometry, − reflectance, − and calorimetry also have precedence as process monitoring tools.…”

Section: Introductionmentioning

confidence: 99%

Industry Perspectives on Process Analytical Technology: Tools and Applications in API Development

Chanda

Daly

Foley

et al. 2014

Org. Process Res. Dev.

Self Cite

148

114

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The IQ Consortium reports on the current state of process analytical technology (PAT) for active pharmaceutical ingredient (API) development in branded pharmaceutical companies. The article uses an API process workflow (process steps from raw material identification through to finished API) to provide representative examples, including why and how the pharmaceutical industry uses PAT tools in API development. The use of PAT can improve R&D efficiency and minimize personnel hazards associated with sampling hazardous materials for in-process testing. Although not all steps or chemical processes are readily amenable to the use of the PAT toolbox, when appropriate, PAT enables reliable and rapid (real or near time) analyses of processes that may contain materials that are highly hazardous, transient, or heterogeneous. These measurements can provide significant data for developing process chemistry understanding, and they may include the detection of previously unknown reaction intermediates, mechanisms, or relationships between process variables. As the process becomes defined and understanding is gained through these measurements, the number of parameters suspected to be critical is reduced. As the process approaches the commercial manufacturing stage and the process design space is established, a simplification of the monitoring and control technology, as much as is practical, is desired. In many cases, this results in controls being either off-line, or if in situ control is required, the results from PAT are correlated with simple manufacturing measurements such as temperature and pressure.

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On-Line Monitoring of Vacuum Dryers Using Mass Spectrometry

Cited by 14 publications

References 2 publications

New Developments in Chemical Engineering for the Production of Drug Substances

New Developments in Chemical Engineering for the Production of Drug Substances

Neue Entwicklungen bei Anlagen und Verfahren für die Produktion von Pharmawirkstoffen

Industry Perspectives on Process Analytical Technology: Tools and Applications in API Development

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