Biologics Formulation System
Q. How can you accelerate your formulation development?
By using Freeslate’s CM3 Biologics Formulation System.
Formulation screening and accelerated stress studies are an essential step in the development of a stable and effective formulation.
Biologic drugs can be inherently prone to degradation and instability, making designing safe, stable, and effective formulations a
challenge. To develop a stable and effective formulation, scientists perform multiple formulation characterization and stability studies
throughout the drug development process but are often limited to the number of formulations they can screen due to short timelines and
limited resources.
The CM3 Biologics Formulation System1 (BFS, Fig. 1) improves laboratory productivity by providing efficient automated formulation
development with less drug substance. The BFS is an end-to-end workflow for supporting high throughput buffer creation, buffer
exchange, stressing, and analysis, allowing for the rapid development of peptide, protein, antibody, and vaccine formulations. This system
is fully configurable and can be sized and scoped to fit the needs of your formulation laboratory. When combined with Freeslate’s Lab
Execution and Analysis (LEA) software, design information, real-time run information, and analytical results are captured in a centralized
database for easy reporting and fast scientific decisions.
Key Features
• Versatile liquid handling for formulating and analytical sample prep
• Compatibility with vials, microtiter plates, and pre-filled syringes then coupled
with the Pre-Filled Syringe Expulsion System
• Automated buffer exchange in microtiter plate format
• Automated processing and stressing - heat, cool, stir, and shake formulations
• Non-destructive visual inspection of protein formulations with visible particle
detection (>80 μm), turbidity, and color measurements (Fig. 2)
• High throughput pH and viscosity measurements with as little as 100 μl of
material (Fig. 3 and 4)
• Low-bioburden environment with HEPA filters
• Integration with Freeslate LEA provides a comprehensive solution for
experiment design, execution, and data capture and analysis
• Intuitive experiment design in array format with import of DOE designs from
JMP or Design Expert available
• Data capture into centralized database for easy viewing and reporting
Fig. 1: CM3 Biologics Formulation System.
Applications
• Rapidly characterize a wide range of protein formulations with
limited material to easily optimize formulations
• Perform developability and preformulation screens
• Evaluate formulation robustness
• Easily implement DOE to characterize a wide range of formulation
variables to identify new formulations
• Prepare and analyze formulations for pH, viscosity, turbidity, and
visual particles to quickly evaluate formulations
• Perform automated agitation and temperature stress studies with
follow-on automated sample analysis
• Manage and track formulations and analytical results to facilitate
rapid scientific decisions
1
Patent pending - PCT US2013_062395.
Fig. 2: Visual
Inspection Station.
Fig. 3: Multi Channel
pH Probes.
Fig. 4: Viscosity
Station.
Specifications
Functional Requirements
Functional Requirements
Additional Options
Multi Channel pH Probes
Measurement time: <30 s
Range: pH 1 to pH 13
Resolution: 0.01 pH units
Repeatability: ± 0.1 pH units
Visual Inspection Station (VIS) Analyses:
Buffer Exchange
Compatibility: Ultrafiltration microtiter plates
Optimized for Millipore’s MultiScreen Ultracell plates
Pressure range: 0 psig to 60 psig
Vortexing: Up to 1600 rpm
Minimum: 0 rpm
Maximum: 1600 rpm
Speed and duration fully programmable
Multi Channel Liquid Dispenser
6 channel variable volume liquid dispense
Disposable tips for no washing, no sample carry-over
Automated variable pitch for reformatting between plates
and vials
Vial/Plate Gripper
Plate size: Standard microtiter
Vial size: 1 mL to 125 mL
Total mass: Up to 3 kg
Vortexing Station
Orbital: Up to 2000 rpm max
Maximum vortexing mass: 860 g
Heating/Cooling/Stirring Station
Temperature range: -10 °C to 180 °C
Mixing: Up to 750 rpm
Mixing type: Magnetic tumble stirring
Rack/Plate Carousel
Access storage of samples, solutions, buffers, and tips
Plate transfer between robotic systems enabling full
integration
Visible Particle, Turbidity, and Color
Vial size: 2 mL to 20 mL
Minimum vial diameter: 15 mm
Minimum vial height: 32 mm
Maximum vial height: 58 mm
Recommended sample volume: 1 mL in 2 mL serum vial
Measurement time: 2 min to 3 min per vial depending on
analysis technique and replicates
Suspended Visible Particle Detection4
Minimum particle size detected: 80 μm
Maximum solution viscosity: Dependent on vial
configuration:
2ml vial: 30 cP
20 ml vial: 35 cP
Particle count accuracy 5:
No particles: 0 particles detected
1 to 3 particles: Detect at least 1 particle
4 to 9 particles: Actual particle count ±2 particles
10 to 25 particles: Actual particle count ±5 particles
On-Deck Third-Party Instrument Physical Integration
DLS
UV-Vis Plate Reader
Centrifuge
Plate Sealer
Shaking Incubator
Off-Deck Third-Party Instrument Virtual Integration
HPLC
cIEF
Other systems available for virtual integration. Please
contact Freeslate for a full list of systems.
Turbidity
Measurement range: 10 NTU to 1000 NTU
Measurement accuracy: ±5 NTU (for non-absorbing
samples)
Repeatability: ≤3 NTU for 10 consecutive samples
Color Measurement
Color: Correct match of Euro Pharmacopeia BY1-BY7
standards
Viscosity Station 2
Measurement range: 2 cP to 100 cP
Accuracy: ±0.5 cP + 10% of the actual viscosity 3
Repeatability: StDev <0.5 cP + 5% of mean
Sample volume per measurement: 100 μL
Minimum volume in the well: 200 μL
Temperature range: 4 °C to 40 °C
Temperature accuracy: ±1 °C
Measurement time: 6 min/sample
Throughput: 10 samples/h
2
2
Improved accuracy at the lower end is possible using an
alternative method that requires 200 µl of sample and a
measurement range of 2 cP to 30 cP.
3
Based on sample sets run under appropriate lab conditions with
appropriate sample sizes.
4
For information on analysis of exogenous materials not
suspended in the bulk solution, contact Freeslate.
5
Measurement using 80 µm to 300 µm polystyrene beads in water.
10
1. Automated Visual Inspection Station
2. 4-Tip pH Probe
3. Viscosity Station
4. Plate Rack
5. Vortexing Station
6. Cooled Storage Bay
7. Heating/Stirring Station
8. Tip Rack Holder
9. Wash Station
10. Flexible Tool Changer
11. Waste Bin
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CM3 Biologics Formulation System Deck Layout
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