A number of blockbuster biologics worth $200 billion in revenue are expected to lose patent exclusivity by 2030 (1), which presents biosimilar manufacturers a huge opportunity for producing drugs at a much lower cost. However, to gain a foothold in the market, biosimilar developers must consider their manufacturing approach in terms of not only speed to market, but manufacturing efficiency and production costs. In fact, the cost of consumables routinely make up a significant portion of the ongoing manufacturing costs for an approved biosimilar. Consumables, such as resins, filters, and media, impact production costs and can increase cost of goods sold. Managing costs is one factor in price affordability for patients.
Choosing the right consumables can largely impact production efficiency, saving downtime, reducing waste, and decreasing production expenses. Scaling up to production level is made more cost effective by choosing the most reliable consumables, and consumables that more easily meet regulatory requirements enable a faster, more streamlined approval process.
In this eBook, we focus on both considerations for resins, a major operating cost for a vast majority of protein therapeutics, and filtration through a series of articles. The first article delves into protein A capture chromatography in mAb manufacturing. It looks at how protein A resin cost and productivity is influenced during production using different Cytiva protein A resins and manufacturing scenarios as examples. In the second article, we explore cleaning in place (CIP) of chromatography resins, which helps ensure the integrity and safety of the final drug product. The article presents results of a series of experiments looking at the influence of sodium hydroxide concentration on protein A resin cleaning efficiency.
Our final three articles focus on filters and filtration processes, and their impact on cost of consumables. In one, we feature integrity testing of sterilizing-grade filters, diving into the evolving landscape of regulatory expectations for performing pre-use, post-sterilization integrity testing (PUPSIT). The second discusses how to choose the right membrane filter material while the third offers frequently asked questions about direct flow filtration.
In summary, balancing the greatly reduced cost of developing a biosimilar (versus the original biologic reference drug) with the potentially hefty cost of consumables is crucial for efficient and compliant manufacturing. We hope these articles are a starting point for a successful biosimilar manufacturing journey.
Reference
Philippidis A. As Patent Cliff Looms for Biopharma Giants, Smaller Biotechs Face Cash Crunch. Genetic Engineering & Biotechnology News (GEN). Published June 21, 2023. Accessed August 21, 2025.