patfix tm pdna
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PATfix pDNATM
L E A D T H E W A Y O F Y O U R P R O C E S S
Global demand for pDNA production is at an all time high, due to increased need from
Gene Therapy ramp-up. pDNA, as an enabling product, is critical in production of
mRNA, AAV and other therapeutic vectors. Increasing yield and purity in the production
of pDNA is a vital step in meeting such demand. Supporting rapid process develop-
ment and optimization, PATfix pDNA analytical platform is providing reliable in-process
control for pDNA process development and production.
+ Sensitive detector suite for low sample consumption
+ Customized method development and validation of your sample
Key features for your analytical workflow
CIMac pDNA COLUMNS WITH NO
CARRYOVER
ENGINEERED FOR SEPARATION OF
pDNA ISOFORMS AND MULTIMERS
INCLUDED OC/SC pDNA STANDARD
BUILT-IN VALIDATED METHOD AND SOP FOR SEAMLESS ANALYTICS
RELIABLE AND USER-FRIENDLY DATA
MANAGEMENT SOFTWARE FOR PROCESSING AND
VISUALIZATION
USER GUIDE FOR EXPERIMENTAL SETUP
AND EXECUTION
The PATfixTM pDNA platform
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S O F T W A R E
PATfix pDNA platform
HARDWARE
SOFTWARE
METHODS
COLUMNS
Process development and production of pDNA brings together people with different skills and specializa-tions, hence PATfix software is built to address the needs and solve challenges of each. An integral part of the PATfix pDNA value proposition, the PATfix software strips away the complexity of chromatography at the day-to-day operational level, while retaining it for higher level tasks.
+ Single database of chromatograms is combined from multiple analytical systems
+ Easily share interactive results with colleagues, customers and/or regulators
+ Information extraction handled trough user-defined templates
+ Report generation helps ease the paperwork load
+ Data visualization allows for quick progress during process development
+ Part 11 compliance allows easy implementation of PATfix analytics in FDA approval process
PATfix software for pDNA platform
A COMPREHENSIVE GUIDE FOR DAY-TO-DAY pDNA
ANALYTICS
EASY DATA PROCESSING WITH TEMPLATED HANDLING
OF MULTI-DETECTOR & SAMPLE DATA
SERVER/CLIENT-BASED APPROACH – ACCESS DATA
SECURELY FROM ANYWHERE (OFFICE, HOME)
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M E T H O D S
Optimized analytical methods are a key component of a well-functioning analytical system, while method development usually comes with a time-consuming learning curve and optimization.
Take the guesswork out of your analytical work with the PATfix pDNA analytics platform. Fully optimized and validated analytical methods, as well as guidelines for buffer and sample preparation, including detailed SOP, come as part of the HPLC system, allowing users to focus on their specific application. In addition, the PATfix pDNA analytical package includes a pDNA calibration standard, which enables accurate quantification of the pDNA species of interest as well as batch-to-batch and day-to-day performance tracking. Additional in-process robustness is guaranteed by the conductivity and pH monitors, that ensure the analysis is being performed with correct buffers and gradients.
PATfix pDNA platform
HARDWARE
SOFTWARE
METHODS
COLUMNS
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C O L U M N S
PATfix pDNA platform
HARDWARE
SOFTWARE
METHODS
COLUMNS
The CIMac™ pDNA-0.3 Analytical Column is built for fast and reproducible HPLC monitoring and quantitation of plasmid DNA. It separates different plasmid DNA isoforms, enabling in-process control and release testing of pDNA samples at all stages of the purification process. It can be operated at high volumetric flow rates (1 mL/min recommended); therefore, the information about the pDNA quantity and purity can be obtained quickly, reducing hold times. CIMac pDNA-0.3 Analytical Columns is a fast and reliable PAT tool, providing:
RAPID, HIGH RESOLUTION
ANALYSIS, ACHIEVED IN 15 MINUTES
CIP TOLERANT WITH NO CARRYOVER
OC/SC/LIN/MULTI SEPARATION
1.4 μm channel sizes are appropriate for plasmids of up to 8 KBp, while longer plasmids are best analyzed using the CIMac pDNA with 6 μm channel sizes.
Process Analytical Development Services
Extending the PATfix analytical services, we offer to develop a customized PATfix pDNA platform, where the process analytical method is specifically optimized for your sample. Decades of experience working on pDNA has helped us acquire a wealth of knowledge, allowing us to complete process an-alytical development services for our clients’ most challenging samples.
Besides method development and/or method validation of your sample, we will optimize the PATfix pDNA platform with the protocols that best work for your sample, giving you a unique experience.
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H A R D W A R E
Achieving the correct hardware setup for reliable & reproducible analytical gradient separation of large bio-molecules is not trivial, especially from complex mixtures and with pDNA samples frequently varying only in isoform/conformation.
PATfix pDNA platform
HARDWARE
SOFTWARE
METHODS
COLUMNS
Multiwavelength detector 190-700 nm, 4 wavelength monitoring,100 Hz sampling
• Highly sensitive MWD with intelligent temperature control to minimize signal drift
• Monitoring of up to 4 wavelengths in the range of 190-700 nm• Titanium and quartz internals ensure up to 300 bar operating pressure
To execute the task at hand, the PATfix pDNA platform includes the following hardware:
• In-process monitoring of salt concentration and method gradients via contact-less conductivity monitor with a wide range (0.1-999 mS/cm)
• Easy tracking of challenging methods that include a pH gradient, with the included pH probe (working range pH = 2-12, CIP compliant)
Autosampler108 sample slots,4 – 40 °C, Automated needle wash
• Space for up to 108 1.5 mL vials for large workflows.• Automated needle wash ensuring minimal carryover between
experiments• Temperature control (4°C – 40°C) of the sample tray ensures sample
stability
Column oven • Ensures optimal operation by keeping the column at a fixed operational temperature, maximizing accuracy
• High pressure gradient pump (up to 400 bar) with integrated degasser and mixer
• Quaternary buffer switcher for seamless integration of workflows with 4 buffers, allowing for easy Cleaning In Place (CIP) implementation
• Bio-inert ceramic pump heads allowing flow rates of up to 10 mL/min
Pump10 mL/min, 400 bar, Cleaning In Place
Conductivity/pH monitor Contactless probe, 0.1–999 mS/cm,pH 2-12
Optional Fluorescence detector
• For PD tasks based on innovative or challenging nucleic acid samples, where additional characterization power is required the fluorescence detector is key to determine contaminants such as residual HCP and chromatin with intrinsic Trp fluorescence
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PLATFORMS (COMING SOON):
Hardware solutions
mRNA
AAV
PATfix™ AnalyticalPATfix™ Semi-prepPATfix™ Hybrid
Product family
Other products
CIMac™The workhorse of PAT chromatography
Product packsBuy a pack to cover your entire DSP
CIMmultus™Best in class chromo purification with easy scale-up