Analytical

Building Orthogonality into Biosimilar Testing

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Both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have developed regulatory guidelines on biosimilars (1, 2). These comprehensive documents provide clear guidance on what the agencies expect from structural characterization studies. Using state-of- the-art instrumentation and techniques is expected, but the use of orthogonal techniques in structural comparability assessments is also required. The application of orthogonal analytical techniques will provide a firm structural foundation to claims of biosimilarity. Characterization methods verifying and supporting conclusions drawn…

April 13, 2020

A Future-Proof Solution for Bioprocess Applications: The New Eppendorf Flexible Bioreactor Control System Evolves with the Changing Needs of Modern Biotechnology

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In the biopharmaceutical industry’s quality-by-design (QbD) era, optimizing tools for process monitoring and control has become a major focus of development and manufacturing. This increased attention brings challenges into upstream and production processes, cell-line development, process optimization, and scale-up. Suppliers of equipment and technologies also focus on helping their customers improve development timelines. With that increased attention to speed, they are offering tools such as the Eppendorf SciVario twin bioreactor control system to streamline development and maximize flexibility. BPI spoke…

March 3, 2020

Ask the Expert: Best Practices for Aseptic Sampling from Stainless-Steel Equipment

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Turn-key single-use aseptic sampling devices (ASDs) have diminished bioprocess contamination risks significantly. But depending on testing, facility, and storage needs, some ASD container types are more effective than others are. Bobbi Allen (technology expert at Sartorius Stedim Biotech North America, SSB) focused her 8 January 2020 “Ask the Expert” presentation on “what, why, when, and where” operators must sample aseptically from stainless-steel tanks. Using data from in-house testing of aseptic sampling containers, Allen offered key considerations for sterility, process monitoring,…

March 3, 2020

Better Bioprinting Ahead: Breakthroughs and Remaining Challenges

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Bioprinted organs soon could revolutionize clinical trials, transplantation, and regenerative medicine. But as Chris Lo reminds us in a new GlobalData report (1), several technical hurdles must be negotiated before biopharmaceutical companies can harness three-dimensional (3D) bioprinting for such purposes. BPI explores persistent printing problems and promising solutions below by analyzing Lo’s report alongside commentary from founding editorial advisory board member Bill Whitford (bioprocess strategic solutions leader at GE Healthcare Life Sciences), Lev Gerlovin (vice president in the life sciences…

March 3, 2020

eBook: Sensor Technologies — Essential Tools for Bioprocessing 4.0

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Sensors are essential devices that can be used for most, if not all, typical biopharmaceutical development and manufacturing processes to monitor fundamental process parameters such as flow, temperature, pH, and dissolved oxygen throughout all process stages. As the bioindustry progresses toward automation, digitalization, and other “Manufacturing 4.0” concepts, robust single-use and smart sensors for bioprocess monitoring will be needed. Read this BPI eBook to garner valuable perspectives on both of these types of sensors. Discussions herein focus on smart sensor…

February 27, 2020

Evaluating Biosimilars: A View from the Small-Molecule World

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For many years the pharmaceutical industry was dominated by small (usually synthetic) molecules, mixed with a number of nonactive materials and encapsulated or (in the really old days) rolled into pills or pressed into tablets. Although synthesizing the active pharmaceutical ingredients (APIs), formulating the dosage forms, and analyzing the materials at every stage of a product life cycle were not always trivial activities, they were relatively straightforward. Most of the tools needed for analyzing/controlling each step of the manufacturing process…

February 7, 2020

Bioassay Evolution: Finding Best Practices for Biopharmaceutical Quality Systems

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Bioassays help drug developers determine the biological activity (potency) of their products, which has been a biopharmaceutical critical quality attribute (CQA) since long before that concept had a name. Because of their complex nature, bioassays are among of the most challenging experiments to perform reliably with dependably accurate results. Consistent assay performance requires a controlled environment and qualified reagents; skilled analysts who understand cell physiology, regulatory requirements, and the latest techniques; and assay protocols that are intelligently developed, characterized, and…

February 7, 2020

Biopharmaceutical Product Specification Limits and Autocorrelated Data

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Calculations, including statistical tolerance intervals, can assist in the development and revision of specification acceptance criteria. Manufacturing results for attributes of a biopharmaceutical product can be positively autocorrelated. The sample standard deviation — calculated from limited, positively autocorrelated data — tends to underestimate the long-term process standard deviation (1). In this article, simulated data are used to assess the relative performance of statistical tolerance intervals, intervals calculated using the minimum process performance index Ppk approach, and the sample range. Prevalence…

February 6, 2020

Bioprocess Development and Qualification: PAT-Based Stage 1 and 2 Acceleration Strategies

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Well-established process analytical technology (PAT) strategies, such as those based on spectroscopy, bring with them several challenges related to the nature of those tools themselves (1–3). Such tools are multiparametric by design — in the sense that most spectroscopies capture multiple attributes sometimes different in nature (e.g., near-infrared, NIR, captures chemical and physical attributes simultaneously). Often a reference method is required; at other times, indirect calibrations are based on the correlation of one culture attribute with another for which a…

February 6, 2020

Ask the Expert: Cell Culture Media Analysis Using Handheld Raman Analyzers

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In biopharmaceutical manufacturing, cell culture media supply critical nutrients and maintain pH and osmolality to optimize protein product yield. Because media composition and condition have a strong effect on final biologic product quality and production, biopharmaceutical companies monitor media for lot-to-lot variability. Stability testing for degradation due to light exposure, temperature changes, or shelf-life/time is possible with rapid spectroscopic methods. In an 8 October 2019 “Ask the Expert” webinar, O. Dean Stuart (product manager at Thermo Fisher Scientific) explained how…

February 6, 2020