{"id":249747,"date":"2024-08-14T00:54:35","date_gmt":"2024-08-14T00:54:35","guid":{"rendered":"http:\/\/boracdmo.com\/?p=249747"},"modified":"2025-03-14T14:48:36","modified_gmt":"2025-03-14T14:48:36","slug":"scaling-biologics-development-for-commercial-success","status":"publish","type":"post","link":"https:\/\/boracdmo.com\/scaling-biologics-development-for-commercial-success\/","title":{"rendered":"BLOG – Scaling biologics development for commercial success"},"content":{"rendered":"\n

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Scaling biologics for commercial: The importance of adopting a customer-centric approach<\/span><\/span><\/strong><\/h2>\n\n\n\n

In this blog, Bora outlines the key challenges biologics developers face on the journey towards <\/span>commercialization and highlights the importance of finding a development and manufacturing partner adopting a customer-centric approach to overcome scaling issues.<\/span><\/p>\n\n\n\n

Scaling challenges in the dynamic biologic market<\/span><\/span><\/strong><\/h3>\n\n\n\n

The demand for biologics has risen significantly over the last decade, with the global biologics market more than doubling in size, growing from $149 billion in 2010 to an estimated $511.89 billion in 2023 [1]. This has, in part, been driven by advancements in biotechnology and manufacturing processes, such as improvements in cell culture and expression systems resulting in higher titers, and advances in downstream purification, that have enabled the development of more effective and efficient biologics. <\/span> <\/span> As the market continues to expand, drug developers and manufacturers are under pressure to meet growing demand while navigating the complexities of ensuring a smooth and seamless <\/span>scale-up<\/span><\/a>.<\/span> Critically, scaling success relies on drug developers maintaining similar product quality from small-scale to large-scale. However, changes in bioprocess parameters can impact cell growth and metabolism, product characteristics such as glycans species and post-translational modifications. These can subsequently affect the critical quality attributes (CQAs) of the biologic. Having a thorough understanding of how any changes in bioprocess parameters when scaling could impact the CQAs of the biologic is imperative to the success of the project.<\/span> <\/span> Drug developers must also overcome scaling challenges, such as ensuring process robustness for scalability and effectively managing the cost of goods and supply chains.<\/span> <\/span><\/p>\n\n\n\n

Embracing a client-centric approach to scaling<\/span><\/span><\/strong><\/h3>\n\n\n\n

With the above challenges in mind, many biologics developers are looking to expert contract development and manufacturing organizations (CDMOs) to:<\/span> <\/span><\/p>\n\n\n\n