Groton Biosystems Automated Reactor Sampling System Agilent 1200 Series LC System for Online HPLC Assays Manual
Contents
1. Get Rapid and Timely Feedback Benefit from Fully Programmable Clean in Place CIP Agilent 1200 ARS Series Online Bioreactor Sampling Collection and Analytical Tool Solution SAMPLE FROM UP TO EIGHT REACTORS DELIVER TO THE AGILENT L200 SERIES RAPID RESOLUTION LC SYSTEM ANALYTICAL INTERFACE The ARS also supports critical biotech assay requirements including Cell Counting Nutrient Monitoring and Fraction Collection Groton provides optional sample prep for filtration dilution concentration derivatization buffer exchange and pH titration COMPLETE SANITARY BIOREACTOR ISOLATION Sample from multiple bioreactors fermentors biotech downstream processes and pharmaceutical process streams The ARS automatically provides clean in place capabilities Steam in place available for large scale systems CHOOSE THE CONFIGURATION THAT BEST MEETS YOUR REQUIREMENTS ARS800 Sample from up to 8 Reactors and deliver to up to 4 Analytical Instruments ARS400 Sample from up to 4 Reactors and deliver to up to 4 Analytical Instruments ARS100 Sample from 1 Reactor and deliver to 1 Analytical Instrument Rapid Amino Acid Analysis Lu LC Agilent 1200 Series Rapid Resolution LC Column Agilent ZORBAX RRHT Eclipse Plus C18 2 1 x 50 mm 1 8 ym Detector Agilent 1200 Series Fluorescence Detector Sample Amino acids 50 pmol on column 1 ASP Fast analyses such as the quantitation of po m o Bo a 2 amino acids are the key t2. PRODUCT BULLETIN GROTON BIOSYSTEMS AUTOMATED REACTOR SAMPLING SYSTEM AND AGILENT 1200 SERIES LC SYSTEM FOR ONLINE HPLC ASSAYS SAMPLE FROM MULTIPLE REACTORS 24 HOURS A DAY DAYS A WEEK FULLY PROGRAMMABLE FULLY AUTOMATIC CELL CULTURE FERMENTATION PROCESS STREAM Multapleoed roactora Feedback loop Astomated itatta In Dewelogenent prepare A closed loop system for monitoring reactor nutrients helos to ensure proper feeding of reactors to optimize product yields feedback loop in development GROTON BIOSYSTEMS Groton Biosystems LLC e 85 Swanson Road e Boxborough MA 01719 USA Tel 978 266 9222 e Fax 978 266 9223 Email info grotonbiosystems com e TWO GREAT COMPANIES HAVE COLLABORATED TO PROVIDE A TOTAL SOLUTION FOR ONLINE HPLC 4 2 Agilent Technologies 4 GROTON BIOSYSTEMS INCREASE PRODUCTIVITY The Groton Automated Reactor Sampling ARS system and Agilent 1200 Series LC system provide a high level of automation for development scale up and production within biopharmaceutical facilities Enjoy labor savings and productivity gains in sampling and assay of reactors NCREASE SAMPLE FREQUENCY Market research indicates that most companies do not sample frequently because it is expensive and increases the risk of bioreactor contamination However companies would like to sample more often to acquire improved process knowledge The PAT initiative is based on increasing data collection and sampl
3. e frequency in order to better understand and control process parameters ultimately leading to an improvement in process control quality and product yield OPTIMIZE YOUR PROCESS Realize labor efficiency and speed of analysis when compared with traditional manual sampling manual sample prep and bench top analysis Increase process knowledge through the acquisition of real time data with the ARS and Agilent 1200 Series LC systems Online monitoring bridges the gap between the QC Analytical Lab and Method Development Production by automating the process Continuous automated process monitoring allows for labor efficiencies and prompt process decision making ability REDUCE COSTS Direct connection from your bioreactor to your HPLC system eliminates the need for time consuming manual sampling sample prep and analysis sample from your bioreactor any time day or night and send the sample directly to the Agilent 1200 Series LC System Control of the ARS is integrated into the method of the Agilent 1200 Series LC system January 2007 MKT 032 RevA Agilent Pub No 5989 6156EN Web Site www grotonbiosystems com SHORTEN DRUG DEVELOPMENT APPROVAL PROCESS REDUCE PRODUCT DEVELOPMENT CYCLES MAXI MIZE PRODUCTIVITY INCREASE YIELD TRACE PRODUCT QUALITY AND REDUCE LABOR PROCESS ANALYTICAL TECHNOLOGY INITIATIVE Control your Manufacturing through Timely Measurements Reduce the Time and Cost of Routine Bioreactor Sampling
4. ments The ARS supports nutrient monitors from several vendors such as YSI and Nova that can provide analysis for glucose lactate glutamate glutamine sucrose ammonium potassium ethanol lactose methanol and chlorine HPLC is one of the most widely used analytical tools in the biotech industry The ARS delivers sample to any HPLC system that supports a simple digital interface Dependent on the operation the ARS can function as the master controller or as a slave to the HPLC The ARS interfaces to industry standard cell counters such as Vi Cell and Cedex to ensure rapid delivery of Samples as well as the recording and handling of the results Specifications current January 2007 subject to change without notice Groton Biosystems LLC GROTON BIOSYSTEMS 2007 Boxborough MA 01719 USA Wao Agilent Pub No 5989 6156EN Web Site www grotonbiosystems com Groton Biosystems LLC e 85 Swanson Road e Tel 978 266 9222 e Fax 978 266 9223 Email info grotonbiosystems com e
5. o real time 2 okoa e monitoring and optimization of production fm o processes ae i Groton Biosystems LLC e 85 Swanson Road e Boxborough MA 01719 USA a eae RevA GROTON Tel 978 266 9222 e Fax 978 266 9223 Agilent Pub No 5989 6156EN BIOSYSTEMS Email info grotonbiosystems com e Web Site www grotonbiosystems com KEY FEATURES AND BENEFITS OF THE ARS SERIES Sanitary Interface Automated Operation Precision Sampling Sample Prep Options On line Analysis and Sample Collection OPC Data Exchange 21 CFR Part 11 Compliance Modular Flexible Design Comprehensive System Support The dual isolated remote valve interface system provides complete isolation of the reactor from the ARS This interface permits cleaning and flushing directly to the reactor port protecting the reactor from contamination CIP SIP options are available The ARS features method development software to allow a sequence of operations lasting hours days and even weeks This permits scheduled sampling of up to eight bioreactors 24 hours a day 7 days a week The ARS eliminates the labor intensive manual sampling processes The precision design of the ARS minimizes the amount of sample required from the reactor The ARS pulls and delivers samples with outstanding consistency to ensure accurate assay results In addition to pulling the samples the ARS can prepare the samples for further processing or analysis Sample Prep Options cell ly
6. zing enzymatic or chemical sample filtration molecular weight separation in fractions buffer exchange sample dilution and reagent addition The ARS interfaces to nutrient monitors HPLC systems and cell counters as well as a fraction collector When interfacing to analytical instruments the ARS delivers the individual sample to the instrument triggers the analysis and displays and logs the results The ARS automatically cleans and prepares the transfer line for the next sample An optional OPC software package supports the collection of ARS status and process analytical data by a wide range of supervisory systems An optional 21 CFR Part 11 software module is available The ARS acquires and delivers samples from any input port maximum of eight to any output port maximum of four There is no manual configuration required The design allows for maximum flexibility under software control The technical staff at Groton Biosystems has the experience and expertise to adapt the ARS to unique operating environments and procedures to your specific workflow ONLINE INSTRUMENT OPTIONS Fraction Collector Nutrient Monitors HPLC Systems Cell Counters The ARS delivers samples to sterile vials in a fraction collector for post run analysis Using Peltier temperature control the fraction collector maintains temperature in a range of 4 C to 37 C The standard rack supports 30 vials Custom racks are available to meet individual require
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