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aria-label="breadcrumb separator">/</span> <span class="breadcrumb-current-title">Knowledge Is Power: Overcoming Common Bioprocess Challenges</span></div></div></header><div class="site-inner"><div class="content-sidebar-wrap"><main class="content"><article class="post-2866 post type-post status-publish format-standard has-post-thumbnail category-bioprocessing tag-bioprocessing-scale-up tag-bioproduction-regulation tag-cell-culture-media tag-cell-lines tag-cell-therapy-media entry" aria-label="Knowledge Is Power: Overcoming Common Bioprocess Challenges"><header class="entry-header"><h1 class="entry-title">Knowledge Is Power: Overcoming Common Bioprocess Challenges</h1> <span class="post-info-author"> By <a href="https://www.thermofisher.com/blog/author/lifeinthelabstaff/" title="Posts by Life in the Lab Staff" rel="author">Life in the Lab Staff</a> </span> <span class="post-info-date"> 05.06.2024 </span> </header><div class="entry-content"><p><img decoding="async" class="aligncenter wp-image-2867 size-full" src="https://www.thermofisher.com/blog/life-in-the-lab/wp-content/uploads/sites/10/2024/04/bioprocess-dev-challenges.png" alt="Knowledge Is Power: Overcoming Common Bioprocess Development Challenges" width="1570" height="1024" srcset="https://www.thermofisher.com/blog/life-in-the-lab/wp-content/uploads/sites/10/2024/04/bioprocess-dev-challenges.png 1570w, https://www.thermofisher.com/blog/life-in-the-lab/wp-content/uploads/sites/10/2024/04/bioprocess-dev-challenges-300x196.png 300w, https://www.thermofisher.com/blog/life-in-the-lab/wp-content/uploads/sites/10/2024/04/bioprocess-dev-challenges-1024x668.png 1024w, https://www.thermofisher.com/blog/life-in-the-lab/wp-content/uploads/sites/10/2024/04/bioprocess-dev-challenges-768x501.png 768w, https://www.thermofisher.com/blog/life-in-the-lab/wp-content/uploads/sites/10/2024/04/bioprocess-dev-challenges-1536x1002.png 1536w" sizes="(max-width: 1570px) 100vw, 1570px" /></p> <p>Efficient bioprocess development is a vital objective for all biopharmaceutical developers, particularly as product demand rises. Whether the product is a recombinant protein or a vaccine, effectively achieving this goal is essential to accelerate the product to market and enable economically sustainable large-scale manufacturing in the long term.</p> <p>Decisions regarding the bioprocess cell line, media, scale-up, and regulatory approval can have direct effects on overall product speed-to-market and costs.</p> <p>Furthermore, relatively minor mistakes during these stages can slow down regulatory approval and potentially lead to scale-up failures, which can cause additional delays and costs.</p> <p>Fortunately, many of these inefficiencies and mistakes are due to well-known process development challenges which, once understood, can be mitigated, or even avoided altogether. Successfully addressing these common challenges is key to achieving an efficient journey to market and maximizing the biotherapeutic’s potential impact.</p> <h2>Common factors to consider for bench-to-market development</h2> <p><strong>Cell line</strong></p> <p>One of the first steps during bioprocess development is identifying and securing the cell line. The efficiency of this step can set the pace for the entire project.</p> <p>To avoid issues later in the product lifecycle, it is vital to fully understand the cell line license agreement conditions before the project has commenced. Every cell line has a different licensing program, making it important to understand the differences early, as they can dramatically alter long-term costs. This can, in turn, affect the initial economic predictions for the product. For example, any agreement conditions regarding royalty payments or manufacturing obligations associated with process scale-up should be well understood prior to acquiring the cell line.</p> <p>It is also important for such an agreement to outline and clarify certain potential future circumstances, such as whether the license covers multiple molecules or if it is transferable if the cell line is sold to a different manufacturer.</p> <p><strong>Media</strong></p> <p>Once a cell line has been established for a process, a cell expansion medium that enables optimal cell growth and product yield needs to be identified or developed. When working in-house, many biopharmaceutical developers typically begin this process by choosing and testing a variety of commercially available catalog media products with their cell line and then carrying out a spent media analysis, a fresh media analysis, or a fresh or spent supplement analysis.</p> <p>However, this approach can be ineffective without detailed knowledge of the media product formulation and the involvement of the vendor. Developers could essentially be screening in the dark, greatly limiting their ability to gain a complete understanding of the effects of the different media on their process and product.</p> <p>When moving a molecule toward production, one of the best places to start is with a <a href="https://www.thermofisher.com/gl/en/home/life-science/bioproduction/gibco-bioprocessing/gibco-bioproduction-services/media-test-panel-consultation.html">media and/or feed panel.</a> Panels consist of a diverse library of formulations. These formulations allow developers to narrow in on key components. They can then use these positive results to quickly identify a formulation that provides better productivity and higher titers.</p> <p>In cases where catalog or panel options have not met process targets—such as growth, quality, titer, and viability— commercial scale-up may require further media optimization. Some components of the media may require elimination or reduction; these could include serum, insulin, transferrin, cholesterol, recombinant proteins, or hydrolysates, to name a few.</p> <p>Central to the media optimization process is the use of analytics, including both traditional techniques such as spent media analysis and next-generation techniques such as “omics” analysis. The term “omics” or “<a href="https://www.thermofisher.com/gl/en/home/life-science/bioproduction/gibco-bioprocessing/gibco-bioproduction-services/media-development.html">multi-omics</a>” refers to multiple molecular analyses that seek to characterize biological molecules including DNA, RNA, proteins, and metabolites. These technologies enable a revolution in media optimization, allowing developers to achieve detailed insights into cellular pathways and gain a greater look into specific component influences on cell growth and protein production [1].</p> <p>However, conducting omics analyses in-house can require significant investments in both equipment and training. As a result, leveraging an external collaborator with experience in this area can provide a cost-effective way to further understand the relationship between media composition and performance.</p> <p><strong>Scale-up</strong></p> <p>Another area that can lead to development delays and additional costs during process development is scale-up. Ideally, during a process development project, scalability should be a primary consideration from the very start, as a smooth scale-up can reduce the need for costly and time-consuming redevelopment. Considerations around factors that could impact scalability are crucial regarding the media formulation and the manufacturing process. This means that certain factors that could change media performance and process yield need to be understood and carefully monitored.</p> <p>Many different factors can significantly affect scale-up, but most changes involve minor considerations in equipment and media chemistry, which are often overlooked during the scale-up development phase. For example, differences in the type of spargers used in bench-scale and large-scale bioreactors can alter aeration, which in turn can change the dissolved oxygen level and have a major impact on the process. Likewise, there can be media-related chemical issues—such as precipitates forming due to unexpected reactions between components—that only become apparent once the medium is being manufactured in large volumes.</p> <p>To reduce this risk, developers should consider the use of a prototyping media manufacturing facility. Prototyping media manufacturing facilities provide the ability to source and test small-scale batches of non-GMP media—whether catalog, custom, or proprietary—in the process. These facilities can help transition the media to a new format, test the performance of formulation variations, or try unique raw materials in the formulation. The process provides an understanding of the scalability and manufacturability of a formulation while offering insight about the capabilities of a potential media manufacturer.</p> <p>Outside of the process itself, there can also be scale-up challenges regarding media storage that are often not considered at bench scale. One of the most common challenges occurs when developers realize during scale-up that they have insufficient space for liquid media storage, requiring them to transition to a dry format. However, if the suitability of the media for this transition has not been considered during development, this process can require time-consuming redevelopment.</p> <p><strong>Regulatory compliance</strong></p> <p>In addition to causing issues during media development and scale-up, a lack of experience with regulatory requirements can also lead to process development challenges. This is true for both the cell line and the media development stages and can result in time-consuming delays to the regulatory filing process and dramatically reduce speed-to-market.</p> <p>Challenges in this area are particularly important to consider as early as possible, as often decisions made during initial development can lead to regulatory hurdles later down the line. One common example of this is the use of an animal-derived product or component in cell line development, such as porcine-derived trypsin, despite ultimately pursuing a final process that is free of animal origin–derived components. This can be a costly error as it could require major redevelopment of the process.</p> <p>Further, even without errors, the regulatory filing process can take a long time to complete because of the large amount of data that needs to be submitted. Therefore, leveraging a knowledgeable supplier who understands how to maximize the efficiency of this process can help avoid delays and keep planned development timelines on track.</p> <p><strong>Knowledge as a pathway to success</strong></p> <p>Given the importance of bioprocess development toward setting the pace of getting biopharmaceutical products to commercial launch, the need for this to be as successful and efficient as possible is clear. It is also clear that, regardless of whether process development is undertaken in-house or with an external collaborator, many potential challenges can arise during the process.</p> <p>However, in both cases, identifying and understanding these challenges, along with determining strategies to overcome or mitigate them, can help to smooth the development process, and help gain efficient product regulatory approval. Overall, gaining this knowledge and successfully addressing these challenges can help reduce risk, dramatically increase the likelihood of successful process development, and accelerate the delivery of innovative new treatments to the patients who need them.</p> <p><strong>References</strong></p> <ol> <li>Stolfa G, Smonskey MT, Boniface R, Hachmann A‐B, Gulde P, Joshi AD, Pierce AP, Jacobia SJ, and Campbell A. (2018), CHO‐Omics Review: The Impact of Current and Emerging Technologies on Chinese Hamster Ovary Based Bioproduction. Biotechnol. J. 13: 1700227.</li> </ol> <h2>Related links</h2> <ul> <li><a href="https://www.thermofisher.com/gl/en/home/life-science/bioproduction/gibco-bioprocessing/cell-therapy.html">Gibco Cell Therapy Scale-Up Solutions</a></li> <li><a href="https://www.thermofisher.com/gl/en/home/life-science/bioproduction/gibco-bioprocessing/cell-therapy/media.html">Gibco Cell Therapy Bioprocessing Media</a></li> <li><a href="https://www.thermofisher.com/gl/en/home/life-science/bioproduction/gibco-bioprocessing/gibco-bioproduction-services.html">Gibco Media by Design Services</a></li> </ul> <aside class="mashsb-container mashsb-main "><div class="mashsb_above_buttons">Share this article </div><div class="mashsb-box"><div class="mashsb-buttons"><a class="mashicon-facebook mash-large mashsb-noshadow" href="https://www.facebook.com/sharer.php?u=https%3A%2F%2Fwww.thermofisher.com%2Fblog%2Flife-in-the-lab%2Fbioprocessing-overcoming-common-bioprocess-development-challenges%2F" target="_top" rel="nofollow"><span 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} $.each(elems, function(index, elem) { var inElementsArray = $.inArray(elem, options.elements); var inCacheArray = $.inArray(elem, cache); if (inElementsArray != -1) { options.elements.splice(inElementsArray, 1); } if (inCacheArray != -1) { cache.splice(inCacheArray, 1); } }); }; /* * Throttle function borrowed from: * Underscore.js 1.5.2 * http://underscorejs.org * (c) 2009-2013 Jeremy Ashkenas, DocumentCloud and Investigative Reporters & Editors * Underscore may be freely distributed under the MIT license. */ function throttle(func, wait) { var context, args, result; var timeout = null; var previous = 0; var later = function() { previous = new Date; timeout = null; result = func.apply(context, args); }; return function() { var now = new Date; if (!previous) previous = now; var remaining = wait - (now - previous); context = this; args = arguments; if (remaining <= 0) { clearTimeout(timeout); timeout = null; previous = now; result = func.apply(context, args); } else if (!timeout) { timeout = setTimeout(later, remaining); 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