Process Analytical Technology PAT | R&D, Scale-up & Manufacturing

Process Analytical Technology (PAT)

PAT is Changing Chemical Process Development, Scale-up, and Manufacturing

Process Analytical Technology (PAT)

Process Analytical Technology in R&D
Process Analytical Technology (PAT)
In Situ Reaction Analysis Tools
Inline Particle Characterization
Heat Flow Calorimetry in PAT

Applikationer

Measure Crystal Size Distribution
Gør krystalliseringen bedre med inline partikelstørrelse, og -form, samt måling af partikeltal

In-process sondebaserede teknologier anvendes til at spore partikelstørrelse og formændringer ved fuld koncentration uden at fortynding eller ekstraktion er nødvendig. Ved at spore hastigheden og graden af ​​ændring i partikler og krystaller i realtid, kan de korrekte procesparametre til ydeevne ved krystallisering optimeres.

Krystallisering
Optimer krystalstørrelse, -udbytte og -renhed

Optimering og opskalering af krystallisering og bundfældning for at fremstille et produkt, der konsekvent opfylder specifikationer for renhed, udbytte, form og partikelstørrelse, kan være en af ​​de største udfordringer i procesudvikling.

Chemical Process Development & Scale-Up
Design Robust and Sustainable Chemical Processes For Faster Transfer To Pilot Plant and Production

Design Robust and Sustainable Chemical Processes For Faster Transfer To Pilot Plant and Production

Impurity Profiling of Chemical Reactions
Automated Drug Development Strategies for Chemists

Knowledge of impurity kinetics and mechanism of formation is important in determining reaction end-point in chemical and process development studies. Accurate, reproducible, and representative reactions samples are necessary for these studies.

Kemisk reaktionskinetik
Undersøg kemiske reaktionshastigheder og mål kinetik inline

In situ-kemiske reaktionskinetikundersøgelser giver en forbedret forståelse af reaktionsmekanismen og vejen ved at tilvejebringe koncentrationsafhængighed af reagerende komponenter i realtid. Kontinuerlige data i løbet af en reaktion muliggør beregning af hastighedslove med færre eksperimenter på grund af den omfattende karakter af dataene.

Flow Chemistry
Improve Safety, Reduce Cycle Time, Increase Quality and Yield

Continuous flow chemistry opens options with exothermic synthetic steps that are not possible in batch reactors, and new developments in flow reactor design provide alternatives for reactions that are mixing limited in batch reactors. This can often result in better product quality and higher yield.  When coupled with Process Analytical Technology (PAT), flow chemistry allows for rapid analysis, optimization, and scale-up of a chemical reaction.

Grignard Reaction Mechanisms
Understand and Control Exothermic Events

Grignard reactions are one of the most important reaction classes in organic chemistry. Grignard reactions are useful for forming carbon-carbon bonds. Grignard reactions form alcohols from ketones and aldehydes, as well as react with other chemicals to form a myriad of useful compounds. Grignard reactions are performed using a Grignard reagent, which is typically a alkyl-, aryl- or vinyl- organomagnesium halide compound. To ensure optimization and safety of Grignard reactions in research, development and production, in situ monitoring and understanding reaction heat flow is important.

Formulations and Product Development
Develop Solid and Liquid Formulations With Desired Disintegration and Dissolution Profiles

Develop Solid and Liquid Formulations With Desired Disintegration and Dissolution Profiles

A Strategic Approach to Defining Critical Process Parameters

Quality by Design (QbD) is an important means to produce high value products, including pharmaceuticals, with consistent quality. Fundamentally, QbD embraces the concept that quality cannot be achieved by simply testing, it must be designed into the process from the beginning. Science and risk-based methods are used to define process parameters that may impact CQAs.

Measure Crystal Size Distribution

In-process sondebaserede teknologier anvendes til at spore partikelstørrelse og formændringer ved fuld koncentration uden at fortynding eller ekstraktion er nødvendig. Ved at spore hastigheden og graden af ​​ændring i partikler og krystaller i realtid, kan de korrekte procesparametre til ydeevne ved krystallisering optimeres.

Krystallisering

Optimering og opskalering af krystallisering og bundfældning for at fremstille et produkt, der konsekvent opfylder specifikationer for renhed, udbytte, form og partikelstørrelse, kan være en af ​​de største udfordringer i procesudvikling.

Chemical Process Development & Scale-Up

Design Robust and Sustainable Chemical Processes For Faster Transfer To Pilot Plant and Production

Impurity Profiling of Chemical Reactions

Knowledge of impurity kinetics and mechanism of formation is important in determining reaction end-point in chemical and process development studies. Accurate, reproducible, and representative reactions samples are necessary for these studies.

Kemisk reaktionskinetik

In situ-kemiske reaktionskinetikundersøgelser giver en forbedret forståelse af reaktionsmekanismen og vejen ved at tilvejebringe koncentrationsafhængighed af reagerende komponenter i realtid. Kontinuerlige data i løbet af en reaktion muliggør beregning af hastighedslove med færre eksperimenter på grund af den omfattende karakter af dataene.

Flow Chemistry

Continuous flow chemistry opens options with exothermic synthetic steps that are not possible in batch reactors, and new developments in flow reactor design provide alternatives for reactions that are mixing limited in batch reactors. This can often result in better product quality and higher yield.  When coupled with Process Analytical Technology (PAT), flow chemistry allows for rapid analysis, optimization, and scale-up of a chemical reaction.

Grignard Reaction Mechanisms

Grignard reactions are one of the most important reaction classes in organic chemistry. Grignard reactions are useful for forming carbon-carbon bonds. Grignard reactions form alcohols from ketones and aldehydes, as well as react with other chemicals to form a myriad of useful compounds. Grignard reactions are performed using a Grignard reagent, which is typically a alkyl-, aryl- or vinyl- organomagnesium halide compound. To ensure optimization and safety of Grignard reactions in research, development and production, in situ monitoring and understanding reaction heat flow is important.

Formulations and Product Development

Develop Solid and Liquid Formulations With Desired Disintegration and Dissolution Profiles

Quality by Design (QbD) is an important means to produce high value products, including pharmaceuticals, with consistent quality. Fundamentally, QbD embraces the concept that quality cannot be achieved by simply testing, it must be designed into the process from the beginning. Science and risk-based methods are used to define process parameters that may impact CQAs.

Publikationer

White Papers

Effektiv procesudvikling ved krystallisering
Kvaliteten af en krystalliseringsproces har stor indflydelse på kvaliteten af det endelige produkt. Vores nye white paper introducerer dig for grundla...
How to Optimize a Crystallization Step Using Simple Image Analysis
By quickly identifying unnecessary hold times and determining how cooling rate influences crystal growth and nucleation, the cycle time for an interme...
Proces FTIR til sikker udførelse af en reduktion af natriumborhydrid
John O'Reilly fra Roche Irland gennemgår et bæredygtigt procesanalytisk teknologi (PAT)-system, ved brug af proces FTIR til sikker udførelse af en red...
In Situ Monitoring of Chemical Reactions
'How to do more with less?' is a constant topic in chemical development laboratories as researchers need to quickly and cost-effectively deliver chemi...
Hurtig analyse af kontinuerlige reaktionsoptimeringsforsøg
White paper - Hurtig analyse af kontinuerlige reaktionsoptimeringsforsøg - gennemgå, hvordan man optimerer kemiske reaktioner.
Effektive Design of Experiment-undersøgelser
Dette white paper beskriver Design of Experiments (DoE)-tilgangen, og hvordan den bruges til at identificere forholdet mellem parametre, der definerer...
Risici fra stigende temperatur
Ved opskalering af kemiske processer, er forståelse af temperaturændring og den dermed forbundne varme, der akkumuleres ved reaktionen, vigtigt for pr...
PAT for Emulsions
Use PAT for emulsions and suspension characterization without the need for sampling or sample prep.
Monitor Tablet & Granule Disintegration
The role of in-process particle measurement to complement traditional API dissolution studies is presented. The use of particle size and count measure...
Particle Size Analysis for Process Optimization
This white paper introduces some of the most common particle size analysis approaches and how they can be deployed for the effective delivery of high...

On-Demand Webinars

Breaking Barriers to Manufacturing Innovation
Frederic Buono discusses how Boehringer Ingelheim uses continuous flow technology to break barriers in manufacturing innovation.
Crystallization Image Analysis
Presented by Prof. Zoltan Nagy of Purdue University, this talk provides an overview of recent advances of applications for in situ imaging and image a...
Flow and Batch Chemistry Monitoring
Charles Goss presents examples illustrating how GlaxoSmithKline (GSK) monitors flow and batch chemistry unit operations in both laboratory and pilot p...
Liquid-Liquid Phase Separation
This presentation describes a strategy employed to design and develop robust, scalable crystallization processes that avoids Liquid-Liquid Phase Separ...
New Tools For Continuous Flow Chemistry
Andrea Adamo of MIT and Zaiput Flow Technologies discusses new tools for continuous flow chemistry advancement.
Agglomeration & Crystallization Using Particle Measurement
This presentation details how using data from in situ particle vision and measurement tools can be used to determine particle size and shape trends re...
Lubrizol - procesudvikling og opskalering
Dette webinar fokuserer på, hvordan man forbedrer procesudvikling og opskalering ved at udnytte kalorimetri og in situ-procesanalyse. For at yde den b...
Mercks udvikling af kemiske processer
Shane Grosser gennemgår, hvordan Mercks laboratorium for procesudviklingsintensivering udvikler nye værktøjer og metoder for at øge hastigheden og ned...

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