BioPharm International - July 2021

BioPharm - July 2021 - Biopharmaceutical Analysis

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14 BioPharm International eBook July 2021 www.biopharminternational.com Biopharmaceutical Analysis Method Validation To t r u l y e v a l u a t e a l l o f t h e moving parts of the process and the analytical method, a simple calculator can integrate and evaluate all of the sou rces of er ror a nd demonst rate acceptance criteria and their inf luence on OOS rates for any CQA. This c a lc u l ator fac tor s i n t he proce s s variation with the assay variation. If the process variation is higher, the assay allowable error will need to be reduced to have an OOS rate less than 100 parts per million (ppm). Also, if the process variation is low, then the assay error may be larger and still meet the <100 ppm goal. Figure 1 shows an example of the elements of the above budget and integrates them all into an overall assessment of the probable OOS rate in percent and ppm. The calculator may be downloaded from the reference website (w w w. bioassaysciences.com). REFERENCES 1. ICH, Q2(R1) Validation of Analytical Procedures: Text and Methodology, Step 4 version (2005). 2. ICH, Q9 Quality Risk Management, Step 4 version (2006). 3. USP, USP General Chapter <1033>, "Biological Assay Validation," USP 35– NF 30 (Rockville, MD, 2012). BP The emergence of new, more complex biological mole- cules being developed as therapeutics has highlighted the importance of having robust analytical methods to characterize these molecules and provide data signifi- cant for their clinical development. To that end, there is a growing focus on enhancing and/or boosting analytical capabilities, as demonstrated by the following examples. SPT Labtech In February 2021, SPT Labtech, a developer of auto- mated instrumentation and consumables, acquired BioMicroLab, a US-based robotics automation provider that designs and manufactures laboratory automation equipment for biotechnology and scientific research. The acquisition expands SPT Labtech's sample management capabilities. BioMicroLab's sample handling and tracking solutions complements SPT Labtech's capabilities in modular, automated sample storage systems while expanding SPT Labtech's product portfolio. This acquisition enables SPT Labtech to create end-to-end analytical solutions that can streamline sample management workflows (1). CatSci In June 2021, CatSci opened a new laboratory in Da- genham, UK, dedicated to analytical excellence as part of its £3-million (US$4.15-million) investment plan. The new lab focuses on combining analytical and syn- thetic chemistry expertise with the latest high-end equipment to solve complex problems in the pharma- ceutical industry. The lab is fully equipped with state- of-the-art analytical equipment (via a collaboration with Shimadzu) and provides high-quality analytical data and critical interpretation. The facility better equips the company to meet the demand for solving multi-disciplinary analytical problems, a growing need driven by the progress of new modalities and asset classes, such as oligonucleotides and cannabinoids. Furthermore, new or modified regulatory requirements, such as nitrosamine determinations and trace impurity analysis, require the development of highly specific and sensitive methods. The company also plans to upgrade the site with capacity for good manufacturing practice analytical development and testing, which will enable the company to support early development pre-clinical data packages to late development Phase III impurity fate studies (2). Waters Also in June, Waters launched its new SELECT SERIES multi reflecting time-of-flight (MRT) mass spectrom- etry platform, which offers high-quality resolution at fast speeds. The instrument combines MRT technol- ogy with enhanced desorption electrospray ionization (DESI) and new matrix-assisted laser desorption ioniza- tion (MALDI) imaging sources. DESI is a soft ionization technique performed under ambient environmental conditions, requiring no prior sample preparation. MALDI is a complementar y technique for imaging biological molecules. With these technologies combined, scientists can more precisely explore molecular structure and function with a combination of speed, resolution, and mass accuracy. For instance, a scientist can study how an investigational oncology drug interacts with its intended target, such as a specific brain tumor receptor, and now has the capability to do so much faster speeds—up to 10 Hz—without compromising mass accuracy or resolution. This new MRT platform forms the basis of next-generation high- resolution mass spectrometers from Waters (3). References 1. SPT Labtech, "SPT Labtech acquires BioMicroLab," Press Relase, Feb. 15, 2021. 2. CatSci, "CatSci opens new Dagenham laboratory dedicated to analytical excellence," Press Release, June 8, 2021. 3. Waters, "Waters Sets New Standard in High Resolution Mass Spectrometry with SELECT SERIES Multi Reflecting Time-of- Flight Platform," Press Release, June 8, 2021. —Feliza Mirasol Complex biological molecules highlight analytics focus

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