Bio/Pharmaceutical Analysis, Raman

As equipment evolves and use of PAT increases, DOE is becoming an integral part of upstream bioprocess development.

Metrohm gains B&W Tek’s line of spectroscopy instruments as well as expertise and facilities.

Waters debuted a range of new TA Instruments innovations and the BioAccord System at Pittcon 2019 in Philadelphia, PA, on March 17–21, 2019.

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.

Tornado Spectral Systems, winner of the 2018 CPhI Excellence in Pharma Award for Analysis, Testing, and Quality Control, discusses real-time process measurement for biopharmaceutical and small-molecule drug manufacturing.

By adapting techniques from other sciences-and exploring better tools for biologics drug development-researchers are addressing challenges of protein characterization.

The acquisition will increase Metrohm’s spectroscopy offerings and capabilities.

New technologies, such as NIR and Raman, enable online measurements of blending and content uniformity in the production of solid dosage forms.

Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.

MDRS differentiates the API from the product matrix and enables measurement of particle size and shape.

The RA802 Pharmaceutical Analyzer from Renishaw is a compact benchtop Raman imaging system that enables users to formulate tablets by speeding up the analysis of tablet composition and structure.

B&W Tek’s director of Market and Customer Development, Katherine A. Bakeev, PhD, discusses analysis of pharmaceutical raw materials and the benefits of using handheld Raman spectrometers.

Live Track focus tracking technology on the Renishaw inVia Qontor Raman microscope enables the analysis of samples with uneven, curved, or rough surfaces.

Rigaku Analytical Devices’ Progeny 1064nm handheld Raman analyzer is compliant with the new calibration standards published by the European Pharmacopeia .

The Thermo Scientific TruScan RM Analyzer features a chemometrics package that allows users to build customized models for both qualitative and quantitative sample predictions.

Thermo Scientific TruTools chemometrics package extends the capabilities of the portable TruScan RM Raman Analyzer.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

The BallProbe from MarqMetrix is an optical sampling interface for inline, real-time measurements.

MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

The authors describe how a combination of imaging techniques can be used to provide topographic and chemical information to characterize a sample.

New systems that combine Raman spectroscopy with automated imaging support the efficient gathering of such data, including information concerning size and shape distributions for individual components within a formulation.

The way in which a suspension nasal spray product interacts with the body depends not only on the droplet size of the delivered droplet, but also on the particle size of the suspended API.

Nanotechnology is an important area of drug and biomedical research, and advancing nano-analysis is crucial for its further development.

The authors developed a method to accurately measure the average molecular weight of large poly(ethylene glycols) (PEGs) using ion-mobility time-of-flight mass spectrometry coupled with gas-phase ion–molecule reactions.

A new Raman spectroscopic method to detect magnesium stearate in powder blends and tablets is described. High-volume pharmaceutical manufacturing requires the use of lubricants to facilitate tablet ejection from compressing machines. However, lubricants may also bring a number of undesired problems that have been widely documented in pharmaceutical scientific literature. New analytical methods are needed to understand lubrication and provide process knowledge in support of FDA's process analytical technology initiative. The detection of magnesium stearate in lactose, mannitol, corn starch and other commercially important excipients is reported. The Raman spectroscopic method has a detection limit of about 0.1% (w/w) based on the 2848 cm-1 band that corresponds to the symmetric stretch of the methylene group in magnesium stearate.

Raman spectroscopy has become a commonly used technique for physicochemical analysis that possesses many advantages over other analytical techniques. It is a very attractive characterization tool, not least because it enables measurements in water. However, very few examples of its application in an aqueous environment exist in literature. This paper provides some recent applications of Raman spectroscopy in pharmaceutical material and process characterization when water is present.

The first part of this article introduced the basic features of Raman spectroscopy and presented some examples of its application in the pharmaceutical industry. This second part focusses on the technique's application as a PAT tool within the pharmaceutical manufacturing environment. FDA's PAT initiative has provided motivation to explore the application of 'new' analytical technologies to the pharmaceutical manufacturing process and Raman spectroscopy shows great promise. The strengths and weaknesses of the technique as a potential PAT tool are discussed together with some examples of how this works in practice in a pharmaceutical manufacturing environment.

Detection and identification of different polymorphic forms is, therefore, important throughout the drug development and manufacturing process.