In general, how has use of spectroscopy for pharmaceutical applications advanced over the last 20 years?
Spectroscopy has evolved over the past 20 years from a research tool to a routine QA tool for incoming material inspection and has been widely adopted in process applications. Since the US FDA Guidance for Industry on Process Analytical Technology (PAT) in 2004, the accompanying Quality by Design (QbD) initiatives, and the European Medicines Agency guidance for the pharmaceutical industry, Raman and near-infrared spectroscopy have been increasingly used as rapid, nondestructive analysis tools from the start to end of many different pharmaceutical unit operations. As the popularity of molecular spectroscopy has grown, the instrumentation and user interfaces have also been further developed to fit to application-specific needs.
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Portable, rugged Raman and NIR instruments were first routinely used for incoming raw material inspection in the warehouse or loading dock. These systems typically have easy-to-use software for rapid identification via on-board libraries, avoiding the need for spectral interpretation and making them accessible to all levels of users.
Due to the high information content of Raman and NIR spectroscopy and their ability to provide results much more rapidly and without any sample preparation as compared to traditional separations techniques, they are now replacing chromatography for in-process testing as well as for content uniformity in final product testing. Various molecular spectroscopy techniques are also used to monitor processes such as chemical reactions (API), blending, granulation, and are moving more towards process control, whether it is real-time process monitoring, aiding in process understanding, or identifying critical process parameters and quality attributes.
Over this same time period what has been B&W Tek’s mission? How has the company helped the pharmaceutical industry bring safe and effective treatments to market over the last 20 years?
B&W Tek was founded in 1997 as an OEM provider of lasers, spectrometer modules and components. Over time, we have grown by coupling our core technologies to be a leading provider of total spectroscopic solutions to industry, government and academia. Our company mission is to be the global leader in Mobile Molecular Spectroscopy Solutions.
We strive to partner with our customers and distributors in finding solutions to improve the general condition of humankind in better health, a protected environment and a safer world.
In 2011, we introduced the NanoRam®, a dedicated handheld Raman instrument for incoming raw material testing with 21 CFR part 11 compliant software to meet the requirements of the pharmaceutical industry for 100% container verification. Our portable and handheld Raman instruments are used in applications from raw material testing, drug polymorph screening, cancer diagnostics, reaction monitoring, counterfeit detection, and content uniformity testing. B&W Tek has helped companies across the globe verify the identity of their incoming raw materials, thus ensuring from the onset that proper materials are used in pharmaceutical manufacturing. Using the NanoRam, one major pharmaceutical company was able to detect an incorrect polymorphic form of a raw material that was being introduced into their material supply chain due to an issue with the supplier, and they were able to make changes to prevent making an ineffective product.
Customers also use our Raman instruments in their product and process development labs as they synthesize new drugs and formulate new products. In-situ Raman spectroscopy has aided the development of efficient and effective reaction conditions. Additionally, content uniformity testing of tablets by transmission Raman with the QTRam™ aids final product quality testing, ensuring the right drug at the right concentration is present in solid dosage form products.
Specifically, what spectroscopy solutions and services does B&W Tek currently offer to assist pharmaceutical clients to conduct rapid noninvasive and non-destructive analysis of all pharmaceutical materials?
B&W Tek has a full suite of handheld and portable Raman instruments for the pharmaceutical industry, from the handheld NanoRam for raw material testing to our portable Raman instruments that are used at line and in the laboratory. Our i-Raman series of portable fiber-optic Raman instruments are used for QA evaluation of competitive products and counterfeit detection, at-line product testing, verifying the correct ingredients at the correct concentrations are introduced to a process, as well as for in-situ reaction monitoring in API process development.
The STRam™ is based on patent-pending see-through technology that expands Raman capabilities beyond the limits of conventional Raman to measure through transparent packaging and can make measurement through opaque packaging. The STRam also has a larger sampling area, improving the ability to assess blend uniformity across a representative sample area using Raman.
We continue to innovate and provide solutions to the industry with our newest product, bringing content uniformity testing to the process line. The QTRam™ quantitative transmission Raman system is used for nondestructive content uniformity testing of solid dose tablets. The transmission measurement ensures that the quantity of APIs and other ingredients are measured through the solid dose and not just close to the surface. The specificity of Raman spectroscopy allows for accurate quantitation of multiple tablet components from a single spectrum. The small footprint of B&W Tek’s instruments provides the versatility for them to be used where they are needed and to be easily transported from one location to another, be it the dispensary, QA lab, development lab, or process line.
Looking ahead, are there spectroscopy-based technologies/services being developed now that will help pharma companies bring innovative products to the market? How will B&W Tek meet this challenge for its current and future clients?
Spectroscopy technologies continue to evolve and meet the needs of the pharmaceutical industry, where product quality testing is increasingly built in throughout the product development and manufacturing process and not just at the final product release testing phase.
Recent developments for better penetration though barrier layers and larger area measurements will aid with blend monitoring and content uniformity testing as well as improved material inspection capabilities.
Another area of development is longer wavelength Raman technologies that can be used for the identification of raw materials that are highly colored, which is important in the pharmaceutical and biopharmaceutical industries that use many colored APIs, additives and natural products with inherent color or fluorescence that can be challenging for Raman.
Miniaturized Raman instruments continue to improve in performance and functionality, and there is a growing desire for miniaturized instruments to become sensors that improve process control and efficiency and thus product quality. Developments in system ruggedness and interfaces to various process configurations with data processing and calibration methodologies that are easy to use and give rapid results can be expected. Portable instruments that allow users to conduct quality checks on the ingredients, in the process directly (and not just of a sampled aliquot), as well as on the final product using a single device could become the new norm.