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'''Forced degradation''' is the process of subjecting drug compounds to extreme chemical and environmental conditions to determine product breakdown levels and preliminary degradation kinetics, and to identify degradant species. The stress testing practices that companies use can vary significantly and can have a serious impact on the analytical methodology used throughout the industry.
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  |name        = Sandbox
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  |image      = PAL.png
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  |type        = Base for other pages
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  |id          = Development page
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  |description = This page is a generic template for development
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Forced degradation studies are used for multiple purposes, including demonstration of the specificity of separation methods, gaining insight into degradation pathways, and discernment of degradation products in formulations that are related to drug substances versus those that are related to other ingredients of a formulation. Reliable chemical stability testing data can show how a drug product changes over time with influence of environmental factors.
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=== Company Description ===
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LEAP Technologies, Inc. was founded in 1989 as an [http://leapwiki.com/mediawiki/index.php?title=Category:PAL autosampler] company serving the [http://leapwiki.com/mediawiki/index.php?title=Category:Gas_Chromatography GC] and GC–MS markets. Since then, LEAP has expanded into front-end sample handling for all areas of [http://www.leapwiki.com/mediawiki/index.php?title=Category:Chromatography chromatography] and [http://www.leapwiki.com/mediawiki/index.php?title=Category:Mass_spectrometry  mass spectroscopy], including LC/MS/MS and [http://www.leapwiki.com/mediawiki/index.php?title=Category:MALDI MALDI-MS] as well as robotics for proteomics and fiber optic UV technology for tablet dissolution. LEAP strives to find total solutions for analytical lab automation. One of the major components in LEAP's approach to automation solutions is with the [http://leapwiki.com/mediawiki/index.php?title=Category:PAL PAL] X,Y,Z robot.
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However, FDA guidance for forced degradation is vague with respect to experimental conditions. In order to harmonize the procedures of forced degradation, an automated method for forced degradation was developed, utilizing the CTC LEAP [http://leapwiki.com/mediawiki/index.php?title=Category:PAL PAL]workstation automation system. The Automated Forced Degradation approach significantly reduces the amount of manual labor used to perform the tests and harmonizes the operational procedures of forced degradation. The Automated Forced Degradation system is user-friendly and is intended to be used as a "walk-up system" that is able to prepare forced degradation and linearity samples, perform on-line HPLC analysis as well as generate reports automatically.
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=== The LEAP Story ===
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'''General Description of the Application'''<br>
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LEAP is experienced in providing automation solutions for any process that gathers, treats and delivers samples to an analytical process. Liquid Handling is in most cases involved but we are not limited to that. We can also move,[http://www.leapwiki.com/mediawiki/index.php?title=Balance_PAL weigh] and image objects. Liquid handling includes spraying and printing besides the usual measuring, pipetting, injecting, [http://www.leapwiki.com/mediawiki/index.php?title=Mixing_of_Samples mixing ], [http://leapwiki.com/mediawiki/index.php?title=Cooling_and_Heating_Sample_Storage heating ] or sampling of a variety of liquids. We have the ability to design, engineer, deliver and support simple but unique or complex but simple to use systems. The [http://www.leapwiki.com/mediawiki/index.php?title=Category:LEAP_Shell LEAP Shell] software lets us create solution-specific sample lists and shell methods that synchronize all instruments involved. LEAP Shell is used for LC/LCMS and stand-alone workstations. LEAP uses  [http://www.leapwiki.com/mediawiki/index.php?title=Category:Chronos Chronos Mastersoftware]for GC and GC-MS integrations. Currently, Chronos integrates with Thermo Electron Xcalibur 1.4 and 2.0 GC & Agilent GC and MSD ChemStation. Further data system packages are begin integrate with Chronos so check with LEAP to see if your is.<br>
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It is possible with the configuration of the [http://leapwiki.com/mediawiki/index.php?title=Category:PAL PAL]to automate accelerated degradation experiments.  
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We can provide complete locked-down systems to Value Added Resellers (VARs). Combinations of instruments that we can supply are robotic sampling devices and LC pumps as front-end to LC-MS systems. Single and [http://www.leapwiki.com/mediawiki/index.php?title=Category:Dual_Channel dual channel] LC to one MS that save [http://www.leapwiki.com/mediawiki/index.php?title=Category:Cycle_Times cycle time] and therefore increase throughput are becoming standard Frontend Automation Bundles (FABs). LEAP has available a proven SDK for [http://leapwiki.com/mediawiki/index.php?title=Category:PAL PAL] integration into your [http://www.leapwiki.com/mediawiki/index.php?title=Category:Data_System data system] software.<br>  
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<br>
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One of LEAP's fundamental business philosophies is to build strong client relationships by knowing our customers and responding to their specific needs with superior personal service whether you have one [http://leapwiki.com/mediawiki/index.php?title=Category:PAL PAL] or are VAR of [http://leapwiki.com/mediawiki/index.php?title=Categroy:Theyll_say_its_a_LEAP LEAP's].
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[[Image:System_20080903.png|center|LEAP CTC PAL Forced Degradation Diagram of System]]
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System Uses: The system is an [http://leapwiki.com/mediawiki/index.php?title=Category:HTS HTS PAL], extension kit to hold a 9 Port Selector Valve & [http://www.leapwiki.com/mediawiki/index.php?title=Dilutor Dilutor Accessory] with 2.5ml Syringe hooked to a [http://www.leapwiki.com/mediawiki/index.php?title=Large_Volume_Dispensing#DISPTool_Accessory Dispense Tool], 1L solvent bottles and tubing to selector valve, 6 Port valve, [http://www.leapwiki.com/mediawiki/index.php?title=Category:Fast_Wash_Station Fast Wash Station] with 500 mL bottles, Ambient [http://www.leapwiki.com/mediawiki/index.php?title=Trayholder Trayholder] with long legs for customers plates, 6 Position [http://www.leapwiki.com/mediawiki/index.php?title=Multi_Drawer_Cool_Stack Cool Stack] for Microtiter plates,[http://www.leapwiki.com/mediawiki/index.php?title=Agitator_for_2ml%2C_10ml%2C_20ml_vials Agitator/Heater], 1000ul syringe and adapter<br><br>
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'''Project Ref: LS-FD'''
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<br>
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''Here is what our customer for this project said about Forced Degradation and the PAL at EAS 2009.''<br><br>
 
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''Why Automated Forced Degradation?''<br><br>
 
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'''Why perform forced degradation studies?'''
 
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* Evaluate API bulk and solution stability at acid, base, oxidation, thermal conditions
 
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* Identify degradation route
 
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* Provide guidance for bulk and formulated sample storage conditions
 
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'''Current Issues: all forced degradation done manually, conditions and time are different, generate different degradates
 
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'''When to perform forced degradation studies?'''
 
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* Lead optimization
 
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* HPLC  API development/validation
 
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* IND/NDA filing
 
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'''Why automated forced degradation studies?'''
 
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* Standardized workflow
 
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* Consistent/automatic data sharing
 
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* Increase productivity and efficiency
 
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'''Why kinetic forced degradation studies'''
 
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* Differentiate primary and second degradates
 
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* Estimate degradation rate constants
 
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* Define if the degradation pathway follows 1st order/ 2nd order reactions
 
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<br>
 
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''Bench-top Automation Platform Robotics Development Strategy''<br><br>
 
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* User friendly and walk-up open access system
 
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* Robust, standardized, easy to operate, straightforward to maintain
 
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* Serves multiple purposes
 
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* Design to work with existing data systems when required
 
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* Cost effective solution that minimizes impact of multiple deployments
 
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* Cycle time reduction needs outweigh high throughput centralized HTS service
 
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** Lower volume and sporadic activities that require rapid response
 
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** Increase productivity of time-sensitive work
 
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<br>
 
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''System Layout of PAL''<br><br>
 
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[[Image:FD_LEAP_PAL_Workstation_Overview.png|center|LEAP CTC PAL Forced Degradation System]]
 
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<br>
 
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''Rationale for Selection Automated System''<br><br>
 
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<br>
 
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[[Image:FD_Rationale_for_Selection_Automated_System.png|center|LEAP CTC PAL Forced Degradation System Rationale for Selection of Automated System]]
 
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<br>
 
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''LEAP PAL Workstation - Sample Setup''<br><br>
 
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<br>
 
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[[Image:FD_LEAP_PAL_Sample_Setup.png|center|LEAP CTC PAL Forced Degradation System Sample Setup]]
 
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<br>
 
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''Kinetic Forced Degradation Conditions''<br><br>
 
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<br>
 
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[[Image:FD - Kinetic FD Conditions.png|center|LEAP CTC PAL Forced Degradation System Conditions]]
 
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<br>
 
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''Kinetic Forced Degradation Setup''<br><br>
 
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* Sample Preparation Setup in ChemStation - SeqSchedule
 
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* Online sample preparation and HPLC Analysis
 
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* Data collected in local PC and Atlas*, automated report
 
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<br>
 
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[[Image:FD Kinetic_FD_Software_Setup.png|center|LEAP CTC PAL Forced Degradation System Software Setup]]
 
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<br>
 
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''Case Study - Linearity Compound A''<br><br>
 
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<br>
 
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[[Image:FD Kinetic_FD_Linearity_Compd_A.png|center|LEAP CTC PAL Forced Degradation System Linearity Compound A]]
 
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<br>
 
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''Acid/Base Forced Degradation''<br><br>
 
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* Chromatograms Overlay at 24 hours
 
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<br>
 
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[[Image:FD Kinetic_FD_Acid_Base_Overlay.png|center|LEAP CTC PAL Forced Degradation System Linearity Compound A]]
 
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<br>
 
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''Oxidative Forced Degradation''<br><br>
 
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* Chromatograms Overlay at 24 hours
 
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<br>
 
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[[Image:FD Kinetic_FD_Oxidative_Overlay.png|center|LEAP CTC PAL Forced Degradation System Oxidative]]
 
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<br>
 
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''Kinetic Forced Degradation''<br><br>
 
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* pH 7, t-0,8,16 and 24 hours
 
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<br>
 
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[[Image:FD Kinetic_FD_pH_Overlay.png|center|LEAP CTC PAL Forced Degradation System pH 7]]
 
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<br>
 
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''Kinetic Forced Degradation''<br><br>
 
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* AIBN* Oxidation
 
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<br>
 
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[[Image:FD Kinetic_FD_AIBN_Overlay_Data_Summary.png|center|LEAP CTC PAL Forced Degradation System AIBN Oxidation]]
 
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<br>
 
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''Kinetic Forced Degradation''<br><br>
 
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* Oxidation in PEG 400 Solution
 
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<br>
 
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[[Image:FD Kinetic_FD_PEG_400_Overlay_Data_Summary.png|center|LEAP CTC PAL Forced Degradation System Oxidation in PEG 400 Solution]]
 
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<br>
 
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''Kinetic Automated pH Rate Profile Forced Degradation''<br><br>
 
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<br>
 
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[[Image:FD Kinetic_FD_Automater_pH_Rate_Profile.png|center|LEAP CTC PAL Forced Degradation System pH Rate Profile]]
 
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<br>
 
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'''Summary'''
 
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<br>
 
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* LEAP CTC PAL system is user friendly and is intended to be used as “Bench top walk-up system”
 
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* Automated linearity preparation and calibration
 
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* Automated stress samples of pH profile hydrolysis, nucleophilic oxidation, auto-oxidation, vehicle related oxidation, and thermal
 
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* Kinetic forced degradation and real time online analysis
 
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* Automated report for easy data review and decision making
 
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* It is cost efficiently, robust and requires minimal maintenance
 
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* Most importantly, harmonize the forced degradation procedures from early drug development to IND/NDA filing
 
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* Save chemist’s time and increase productivity
 
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<br>
 
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Automated Kinetic Forced Degradation Development and HPLC Method Validation Presentation 2009 EAS Conference. ''See below for reprint''<br> LEAP wishes to thank the authors for their permission to share their information with you. ''Authors:'' Lina Liu, Timothy A Rhodes, Roy Helmy, Brian Farrer, Edwin C. Pratt, Keri Doolittle, Margaret Figus November 16, 2009 Merck Research Laboratories ''Acknowledgments:'' Merck – Pharmaceutical Analytical Chemistry Bruce J. Acken, Paul A. Harmon<br>
 
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=== Publications ===
 
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[[image: Info icon.png|40px]] [[:Media:EAS_Merck_2008_Poster.pdf‎ |EAS 2008 Poster by Merck on FD system]]<br>
 
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[[image: Info icon.png|40px]] [[:Media:EAS_2009_Forced_D_Presentation.pdf‎  |EAS 2009 Presentation by Merck on FD system]]<br>
 
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{{logo}}
{{logo}}
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=== Contact LEAP ===
=== Contact LEAP ===
{{contact|topic=LEAP and the PAL Platform}}
{{contact|topic=LEAP and the PAL Platform}}
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[[Category:Example Solutions]]
 
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[[Category:Application Publications & Posters]]
 
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<br>''The information and references contained in this web site are believed to be accurate and the most current information available.''
 

Revision as of 23:22, 10 December 2009

Sandbox
Application Type
  Base for other pages
Application ID
  Development page
Description
  This page is a generic template for development
 ↳ leaptec.com  ↳ leapwiki.com

Company Description

LEAP Technologies, Inc. was founded in 1989 as an autosampler company serving the GC and GC–MS markets. Since then, LEAP has expanded into front-end sample handling for all areas of chromatography and mass spectroscopy, including LC/MS/MS and MALDI-MS as well as robotics for proteomics and fiber optic UV technology for tablet dissolution. LEAP strives to find total solutions for analytical lab automation. One of the major components in LEAP's approach to automation solutions is with the PAL X,Y,Z robot.

The LEAP Story

LEAP is experienced in providing automation solutions for any process that gathers, treats and delivers samples to an analytical process. Liquid Handling is in most cases involved but we are not limited to that. We can also move,weigh and image objects. Liquid handling includes spraying and printing besides the usual measuring, pipetting, injecting, mixing , heating or sampling of a variety of liquids. We have the ability to design, engineer, deliver and support simple but unique or complex but simple to use systems. The LEAP Shell software lets us create solution-specific sample lists and shell methods that synchronize all instruments involved. LEAP Shell is used for LC/LCMS and stand-alone workstations. LEAP uses Chronos Mastersoftwarefor GC and GC-MS integrations. Currently, Chronos integrates with Thermo Electron Xcalibur 1.4 and 2.0 GC & Agilent GC and MSD ChemStation. Further data system packages are begin integrate with Chronos so check with LEAP to see if your is.
We can provide complete locked-down systems to Value Added Resellers (VARs). Combinations of instruments that we can supply are robotic sampling devices and LC pumps as front-end to LC-MS systems. Single and dual channel LC to one MS that save cycle time and therefore increase throughput are becoming standard Frontend Automation Bundles (FABs). LEAP has available a proven SDK for PAL integration into your data system software.
One of LEAP's fundamental business philosophies is to build strong client relationships by knowing our customers and responding to their specific needs with superior personal service whether you have one PAL or are VAR of LEAP's.


 ↳ leaptec.com  ↳ leapwiki.com

LEAP strives to find total solutions for analytical lab automation by automating analytical processes for small and large molecules in extracted liquids, solids, and recently in human, animal and plant tissues. We provide the precise robotics and efficient sample prep required by modern measurement techniques such as MALDITOF mass spectroscopy. Our newest specialty customization of CTC Analytics’ PAL features small workstations that can perform complex liquid handling tasks including HPLC-Purification, SPE, filtration, weighing, heating and stirring. They can be configured as stand alone units or integrated for “just in time” sample prep for LC-MS or GC-MS analysis. LEAP provides automated workstation instrumentation solutions based on the LEAP CTC PAL X, Y, Z syringe only autosampler robot from LEAP Technologies. This extremely flexible, precise, and adaptable liquid handling robotic platform is available in a variety of lengths and options depending on the requirements of your sample preparation and injections for your UHPLC, LC or GC chromatography.LEAP offers full support and service for the PAL platform in addition to being able to write custom macros, cycles, and scheduling to your applications. Please contact LEAP Technologies on how we can help you get maximized throughput with flexible pipetting automation solutions.

Contact LEAP

Contact LEAP

For additional information about LEAP and the PAL Platform, please contact LEAP Technologies.

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