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Process Development and Quality

Real-time spectroscopic methods like NIR and Raman spectroscopy, and gas analysis by Chemiluminescence method are used to monitor biopharmaceutical processes, ensuring consistent product quality and detecting deviations early (Quality By Design, QBD). It helps identify and quantify active ingredients, impurities, and other components in biopharmaceutical products, ensuring their identity and purity, and can be used to differentiate genuine biopharmaceuticals from counterfeits, safeguarding patient safety. Spectroscopy and Particle Size Analysis help ensure biopharmaceutical products meet strict quality and safety standards before release to the market. In addition to routine quality control, these same orthogonal, non‑destructive analytical approaches support pharma forensics by enabling the investigation of unknown impurities, process deviations, and counterfeit or compromised products—providing defensible data for regulatory compliance and product integrity assurance before and after market release.

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Recently, nitrosamines, which are likely carcinogenic to humans, have been detected globally in the Sartan class of drugs, Ranitidine and Nizatidine. Medicines regulatory authorities, including the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Japanese Ministry of Health and Welfare (MHLW), have issued notices and guidance to pharmaceutical manufacturers and distributors, requesting self-inspection and assessment regarding the risk of nitrosamine contamination.

Medical gases are regulated by the United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) that sets standards for all medical gases including those that address quality, strength, purity, packaging, labeling, and identification. HORIBA contributes in this field by providing a wide range of analysis and measurement solutions with high accuracy.

Raman Analysis of lysozyme

We have measured solutions of lysozyme under conditions known to effect its physical state in order to investigate the potential of Raman spectroscopy as a non-invasive and label-free tool to assess protein formulation stability. Results from this study identified specific Raman signature bands in this protein that can be used to identify individual amino acid residues that are reflect structural changes in proteins.

Holistic Analysis of Mammalian Cell Proliferation using Fluorescence Spectroscopy

This study demonstrates the application of Excitation Emission Matrix measurement to monitor cell culture medium conditions during the proliferation of mammalian cells.

Fluorescence Emission spectra of transferrin at increasing concentrations

In this application note, we highlight the high sensitivity of the Duetta for measuring transferrin at very low concentrations. The Duetta spectrofluorometer combines both fluorescence and absorbance measurements simultaneously, thus providing key advantages for protein analysis. In parallel, we compare the fluorescence results obtained using the Duetta with absorbance results obtained with a dedicated low-volume, benchtop spectrophotometer.

The complexity of viral particles remains one of the biggest hurdles in the development process. In this note, the upstream process of analyzing viral preparations is addressed, as well as the use of multi-laser nanoparticle tracking analysis (NTA) as a cost and time efficient method to measure size, count virus particles, and correlate to infectious titer.

Protein aggregation is an important concern when developing and manufacturing biotherapeutics since these subvisible aggregate particles have been associated with the adverse drug reactions. Protein aggregates may provoke adverse events through an unwanted immune response. And, regardless of mechanism of reaction, subvisible particle contamination has been a concern for manufacturers and regulators.

Size matters in vaccine delivery systems. Nanoparticles smaller than 200 nm generally present a greater immunogenic response than micro-particles larger than 1 micron. This rather simple statement is based on the common understanding that particles with sizes resembling the dimensions of viruses are treated like viruses by the body.

The study of protein aggregation encompasses a broad range of interactions and mechanisms. Many studies into this subject area investigate the aggregation of misfolded proteins, which is thought to be responsible for many degenerative diseases. Since aggregation typically leads to a physical change in protein size, particle size analysis has proven to be a useful experimental technique in this field.

Sub-visible Particles from ViewSizer 3000

The ViewSizer 3000 enables scientists to visualize and quantify the kinetics of protein aggregation in real-time for biologic therapeutics under a variety of stress conditions including agitation, temperature and the addition of contaminants. The case study featured here validates these capabilities for agitation and temperature stress conditions with the 100 mg/mL mAb A.

Protein scientists typically discuss “protein size” or molecular weight, as opposed to using the phrase “particle size”, but particle size analyzers are often used in their studies. There is also interest in the surface charge or valence of proteins, so zeta potential is another measurement used by protein chemists.

Zeta potential is a key physical parameter that describes surface charge on proteins. Although there has been interest in measuring the zeta potential of proteins for many years, the measurements were often difficult due to a variety of reasons including the “cooking” of proteins on the cell electrodes when using light scattering techniques.

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HORIBA Solutions

PoliSpectra® RPR for HTS

PoliSpectra® RPR for HTS

Rapid Raman Plate Reader – Multiwell Fast Raman screening

XploRA™ PLUS

MicroRaman Spectrometer - Confocal Raman Microscope

Veloci BioPharma Analyzer

Veloci BioPharma Analyzer

A-TEEM Spectroscopy

ViewSizer 3000

Simultaneous Multispectral Nanoparticle Tracking Analysis (NTA)

Duetta: A Versatile Spectrometer for Science and Industry

Duetta: A Versatile Spectrometer for Science and Industry

Unlocking Innovation Across Disciplines

MacroRAM™

Affordable Benchtop Raman Spectrometer

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Watch Webinars and Videos

Join Dr. Kevin Dahl of Particlese LLC and Dr. Linda Kidder of HORIBA Scientific provide tips and alternative solutions for better vaccine development and quality. They will discuss the application of multi-laser nanoparticle analysis (NTA) in determining vaccine degradation and total particle count. They will also present a new analytical approach, fluorescence A-TEEM method for rapid screening of similar but different vaccine final formulations.

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