PRODUCT BULLETIN
GROTON BIOSYSTEMS AUTOMATED REACTOR SAMPLING SYSTEM
AND
AGILENT 1200 SERIES LC SYSTEM FOR ONLINE HPLC ASSAYS
S
AMPLE FROM MULTIPLE
TWO GREAT COMPANIES HAVE COLLABORATED
TO PROVIDE A TOTAL SOLUTION FOR ONLINE HPLC
REACTORS 24 HOURS A
DAY, 7 DAYS A WEEK
ULLY PROGRAMMABLE
F
ULLY AUTOMATIC
F
CELL CULTURE
ERMENTATION
F
ROCESS STREAM
P
A closed-loop system for
monitoring reactor
nutrients helps to ensure
proper feeding of reactors
to optimize product yields
(feedback loop in
development).
Groton Biosystems LLC • 85 Swanson Road • Boxborough, MA 01719 USA
Tel: (978) 266-9222 • Fax: (978) 266-9223
Email: info@grotonbiosystems.com • Web Site: www.grotonbiosystems.com
I
NCREASE 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.
I
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 sample 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.
Agilent Pub. No. 5989-6156EN
MKT-032 – Rev A
January 2007
SHORTEN DRUG
DEVELOPMENT
APPROVAL PROCESS
PROCESS ANALYTICAL TECHNOLOGY INITIATIVE
Control your Manufacturing through Timely Measurements
Reduce the Time and Cost of Routine Bioreactor Sampling
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
REDUCE PRODUCT
DEVELOPMENT
CYCLES
MAXIMIZE
PRODUCTIVITY
NCREASE YIELD
I
TRACE PRODUCT
QUALITY AND
REDUCE LABOR
S
AMPLE FROM UP TO EIGHT REACTORS ….
…DELIVER TO THE AGILENT 1200 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.
OMPLETE, SANITARY BIOREACTOR ISOLATION. Sample from multiple
C
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.
C
HOOSE 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
Fast analyses, such as the quantitation of
amino acids, are the key to real-time
monitoring and optimization of production
processes.
Groton Biosystems LLC • 85 Swanson Road • Boxborough, MA 01719 USA
Tel: (978) 266-9222 • Fax: (978) 266-9223
Email: info@grotonbiosystems.com • Web Site: www.grotonbiosystems.com
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 µm
Detector: Agilent 1200 Series Fluorescence Detector
200
Sample: Amino acids, 50 pmol on column
175
150
125
100
75
50
25
0
0
Mobile phas e A: 10mM Na2HPO4–10mM Na2B4O7, pH 8.2 Flow rate: 0.420 mL/min
Mobile phas e B: ACN:MeO H:H
ASP1
GLU2
ASN3
SER4
GLN5
HIS6
GLY7
2
THR8
1
ARG9
ALA10
TYR11
4
CYS-CYS12
VAL13
MET14
3
NVA15
16
TRP
PHE17
ILE18
LEU19
LYS20
HYP21
SAR22
PRO23
O 45:45:10 by volume Gradient t imetable was used
2
9
10
11
8
7
6
5
22
21
13
18
14
19
17
15
16
12
20
23
min123 4567
January 2007
Agilent Pub. No. 5989-6156EN
MKT-032 – Rev A
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 lyzing (enzymatic or chemical); sample filtration; mole cular weight separation in
fractions; buffer exchange; sample dilution; and reagent addition.
The ARS interfaces to nutrient monitors, HPLC sys t em s, and ce ll 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 outp ut 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
Specifications current January 2007 – subject to change without notice. ©Groton Biosystems LLC
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 requirements.
The ARS supports nutrient monitors from several vend ors 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.
Groton Biosystems LLC • 85 Swanson Road • Boxborough, MA 01719 USA
Tel: (978) 266-9222 • Fax: (978) 266-9223
Email: info@grotonbiosystems.com • Web Site: www.grotonbiosystems.com
January 2007
Agilent Pub. No. 5989-6156EN
MKT-032 – Rev A
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