FlowCam LO (Light Obscuration)
Flow Imaging Microscopy with Light Obscuration
For the first time ever, you can obtain Light Obscuration data to meet USP regulatory guidelines, and also verify your data with real images, all with a single instrument, and a single sample run. Our FlowCam LO instrument combines our patented flow imaging microscopy technology with an embedded light obscuration particle counter to provide you with the necessary data for USP regulations and validation with images.
In FlowCam LO, a single sample passes continuously through two flow cells. The first, uses FlowCam technology to capture digital images and the second, uses the light obscuration method to collect data for USP regulations.
While analysis with light obscuration is standard, the FDA has long made clear that size data alone, collected with light obscuration, is not adequate to ensure safe and effective drugs, and that it’s necessary to provide validation and imaging data using orthogonal methods. FlowCam LO has the orthogonal method built in.
FlowCam LO provides:
- USP <787/788> compliance data with light obscuration
- Flow imaging microscopy validation of particle types with images
- Identification of additional particles missed by light obscuration alone
- Greater understanding of drug product formulation
How does it work?
The Importance of Images provided by FlowCam LO
Given that Light Obscuration compares all particles to a sphere (equivalent spherical diameter or ESD), it’s possible that extrinsic particles roughly the same size as your proteins would pass the LO USP size distribution test. The image below shows the variety of particles you might see with a similar ESD (shown here: proteins, agglomerates, silicone droplets, air bubbles and other contaminants – silica, glass shards). A sample like this might pass USP size limits, but still fail at the trial stage. Verify your data with images, with FlowCam LO.
FlowCam LO Specifications:
- Particle Size Range: 2 µm to 70 µm
- Magnification: 10X
- Flow Cells: Flow Imaging Module: 80 µm x 700 µm quartz; LO Module: 1 mm x 0.4 mm quartz
- Sample Processing Capability: 0.2 mL / minute
- Sample Volume Range: 250 µL – 2 mL
- Flow Imaging Module Camera: High resolution (1920 x 1200 pixels) CMOS (monochrome and colour available)
- Frame Rate: Shutters up to 100 frames per second
- Light Obscuration Light Source: Solid-state laser diode, 785 nm
- Light Obscuration Detection Method: Light extinction, volumetric
- Fluidics: Micro-syringe pump with 2.5 mL syringe
- Equipped with our image analysis software VisualSpreadsheet®
FlowCam LO Benefits
- Streamline drug development
- Use less sample volume for testing (only 250 µL required)
- Save time and sample quantities by using a single instrument
- Reconcile data from a single sample, and a single run with two different technologies
- Correlate your light obscuration data with images from flow imaging microscopy
- Obtain full particle characterization and improved sample throughput time in a single step
- Build particle libraries and automate classification
- Have greater confidence in your data
One instrument. One sample run. Two analytical methods.
Measuring Subvisible Particles and Aggregates Using FlowCam LO.
Measuring and monitoring particulate matter present in injectable drugs is crucial to companies involved in formulation development, manufacturing, and packaging of biopharmaceuticals. Adverse effects caused by protein aggregates and extrinsic particles in these drugs have been well documented over the years. The risks range from reduced efficacy to significant immunogenic responses.
While analysis using light obscuration instrumentation is standard, the FDA has long made clear that size data alone, collected with light obscuration, is not adequate to ensure safe and effective drugs, and that it is also necessary to provide validation and imaging data using orthogonal methods.
With FlowCam LO, you can now:
- Correlate light obscuration data with flow imaging microscopy.
- Reconcile data from a single sample, and a single run with two different technologies.
- Save time and sample quantities by using a single instrument.
- Obtain full particle characterization and improved sample throughput time in a single step.
Early adopters of FlowCam LO are saying:“Our process involves generating highly loaded protein microparticles. We use FlowCam LO to analyse all of these sample types…FlowCam LO has already enhanced & modernized our SVP profiling. Needless to say we have much greater confidence in the data it provides compared to the PV-100!”
– Analytical Development Lead at US Biopharmaceutical Company“In [Flow Imaging Microscopy], the fast acquisition electronics + high quality optics appear better at detecting our materials which are protein-based therapeutics. This tallies with what has been observed in the literature. LO is the compendial method however I have reservations about it’s ability to detect translucent protein particles whose RI is similar to the aqueous medium in which they reside. LO also cannot allow you to perform post-experiment image analysis or to distinguish one species from another (bubble and particle may appear the same).”
– Development Scientist at one of the ten largest Biopharma companies worldwide