Mark Herberger
Director, Particles Business
Clinical Diagnostics Division
Thermo Fisher Scientific
How do your foresee Thermo Fisher Scientific strengthening its position for delivering particle solutions to the pharmaceutical market?
We’ve been in the particle business for 35 years, longer than most, which puts us in a strong position to invest in and expand our proven line of NIST traceable size standards, counting, calibration and set-up beads. These products ensure optimal particle counting, sizing and flow cytometer instrument performance, which is crucial for pharmaceutical companies when developing products that comply with ISO and United States Pharmacopeial Convention (USP) regulations like <729>, <788> and <1027>. Pharma companies can be confident in the quality, uniformity and reproducibility of our beads which we make onsite in our proprietary ISO 13485 and FDA registered facilities.
How do your particles help pharmaceutical companies comply with specific ISO and USP regulations in the development of their commercial products, like injections, parenteral infusions and ophthalmic solutions?
Our Pharm-trol and Count-Cal beads were developed for manufacturers of parenteral drugs and ophthalmic solutions who seek interim verification of USP <788> and <789>. These sections set the standards that detail the acceptable level of foreign particulate material in commercialized products. For these applications, our beads effectively calibrate and check the particle counters and sizers to make sure they are operating at utmost accuracy when controlling for inert and viable organic, and inert organic particulates found in the sample. Otherwise, users risk working with potentially misleading and inconsistent data.
Describe the increasing role that magnetic particles play in bioseparation processes and immunoassay development.
To improve and speed biological sample prep and immunoassay development, our nominal one micron-sized Sera-Mag SpeedBeads come coupled with antibodies and other capture probes, or with chemical functionalities for the customized attachment of antibodies, oligos, proteins, or nucleic acids. With two layers of magnetite encapsulated with a carboxylate-modified polymer shell, the SpeedBeads respond faster to a magnetic field and have a cauliflower-like surface that substantially increases the overall surface area available for attaching capture probes. Since they are superparamagnetic and highly charged, the beads have no residual magnetism outside of an applied magnetic field, resulting in less aggregation. This allows for more reproducible recovery and cleaner sample preparation.
How crucial is it to calibrate and use proper controls to keep flow cytometers operating with high accuracy when analyzing cells?
Flow cytometers are finding increased usage at core and individual labs in drug discovery, immunology, cancer research and more. Because flow cytometer performance can fluctuate daily, it’s vital to have a regular performance check in place. Furthermore, experiments are being compared across different platforms, so standardized instrument set up is essential. For this, we provide three types of Cyto-Cal beads, including: 1) calibration beads to assess linearity and sensitivity, and to ensure the laser and optics perform to specification, 2) alignment beads to assess accuracy and make sure the laser and flow cell are focused, and 3) count control beads for determining the absolute counts of various cell populations.
How do your particles help core and individual labs address and pass strict quality control audits?
Our NIST Traceable Size Standards and Count Control beads are used as reference standards to calibrate, check and validate the results of particle counting and sizing instruments. NIST traceability gives the calibrated instrument an unbroken chain of measurements that goes back to the standard meter at the governmental office at the National Institute of Standards and Technology. The paperwork supplied provides the objective evidence that helps in QC audits by answering the question: “How do you know the instrument is properly measuring?” Because these beads work on an open platform, they can be used without bias to any brand.
How do your fluorescent particles address the need for high sensitivity in lateral flow diagnostic assays?
Sensitivity and accuracy really matters when developing lateral flow diagnostic devices for home tests, Point-of-Care, and diagnostics laboratory applications that check for influenza, drugs-of-abuse, and infectious diseases. To address this, we offer functional Fluoro-Max fluorescent beads internally dyed with europium chelate which has a broad Stokes shift that provides excitation at 333 nm and emission at 613 nm. The fluorescence emitted exceeds the lifetime of most fluorophores by several thousand fold, ensuring maximum color brilliance and analyte binding for greater sensitivity and enhanced readability of the assay. The long-lived fluorescence of europium chelate also helps eliminate background interference from relatively short-lived matrix auto-fluorescence.