September 2023

September 2023: From the Editor

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With another September comes another collective sprint to the end of the year. Because of our three-month minimum span from receipt of a manuscript to its publication, we already are planning our January–February issue. But between now and then, we have plenty to do. The publication’s editors, Dan Stanton’s BioProcess Insider team, and our conference colleagues are gathering up ideas, comparing notes, evaluating trends, and creating editorial and conference calendars for 2024. The BPI conference and colocated meetings are coming…

Cell Culture Media Fingerprinting: A Three-Tiered Approach

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Cell culture media range from simple components to complex chemically defined mixtures. They may contain a number of chemical components, each with individual chemical properties — and any variation in which ingredients can affect cell culture processes and biological products being manufactured. Although simple substances can be identified easily using well-known classical methods such as Fourier-transform infrared spectroscopy (FTIR), analysis becomes more challenging when dealing with complex mixtures. Section VII-3-C of the Q7A guidance from the International Council for Harmonisation…

Engineering the Future: Cell-Line Development Discussions at BPI West

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Big data, next-generation sequencing (NGS), automation, and powerful analytical technologies are helping biopharmaceutical companies achieve the parallel goals of cell-line development: precise integration of transgenes into production cells with documented monoclonality, shortening timelines and increasing productivity. Presentations in the most recent Biotech Week Boston (BWB) and the BPI Conference US West (BPI West) programs have demonstrated that there is no one way to accomplish those goals. Combining several of the approaches highlighted herein just might take biopharmaceutical production to new…

Establishing Microbiological and Particulate Controls When Reworking a Sterile Drug Product

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Reworking of finished sterile-product batches requires particular attention to maintaining microbial and particulate control. The strategy is permitted with regulatory agreement and observation of regulations such as 21 CFR 820 (1). Note that reworking is distinct from reprocessing. Under ICH Q7, reprocessing is confined to intermediates, whereas reworking is reserved for finished products (2). Reworking includes steps that were not part of an initial biomanufacturing process. The reworked steps are process elements that are designed either to bring an out-of-specification…

Validating Prefiltration Dirty-Hold Times for Upstream Media and Feed Solutions: Implications for Establishing In-Process Microbial Control

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Biopharmaceutical manufacturing processes require that prepared raw materials and product intermediates be held at different stages. During hold times, however, process and product intermediates are susceptible to microbial risks from bioburden, endotoxins, and exotoxins. Such risks arise from multiple sources, including bioproduction facilities, equipment, operations, and raw materials. Even a prepared intermediate can help microbes to grow. The US Food and Drug Administration’s (FDA’s) guidance on Sterile Drug Products Produced By Aseptic Processing states that “the time limits established for…

Advancing Vaccine Development with Novel Chromatography Solutions

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The rise of new diseases and infections has increased the need for accelerated development of safe and effective vaccines. In addition, the search for vaccines continues for long-known pandemic diseases such as acquired immunodeficiency syndrome (AIDS) and malaria, for which effective vaccines currently do not exist. To address the difficulties of vaccine development for such indications, scientists are researching new modalities including viral vectors, recombinant proteins, and nucleic acids. However, each vaccine production process is unique and will have its…

Advances in Bioanalytical Tools for the Characterization of In-Process Viral Samples

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The best bioanalytic tools support bioprocess development by enabling scientists to measure and monitor samples throughout an entire bioprocess quickly and efficiently. Sofia Carvalho is a senior research associate at Portugal’s Instituto de Biologia Experimental e Tecnológica (iBET, https://ibet.pt), a nonprofit biotechnology research organization that works to advance biologicals and biotherapeutics research and development by connecting academia and industry. In an April 2023 webinar, she discussed how advances in bioanalytical tools for viral and viral-like sample characterization can improve the…

Unlocking the Power of Wizardry for Regulatory Compliance

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Regulatory compliance is not just a legal requirement, but it is also a critical aspect of ensuring patient safety and trust. The consequences of noncompliance can be severe, incur costly fines, and damage a company’s reputation. Understanding Wizard Tools for Compliance Adobe Acrobat plug-ins from third parties offer users an array of “wizards” that help to streamline the creation of important regulatory documents by addressing different requirements and obstacles. Regulatory compliance can be a challenging and time-consuming process for businesses…