This report will discuss how to streamline development and production of cell culture acceleration and optimization. You will see those opportunities at close reach to further increase speed of development and optimize processes. A curious glance at the novel technologies will let you discover proven models of yield maximization and economy of resources (controlling COGs).
Besides, you will find answers to the following questions: What makes a bioprocess platform a winner setup? Do scaled-up and budget operations need to compromise in quality? Does a bioprocess with state-of-the-art organization warrant biotherapeutics clinical success? Does shifting processes from batch to continuous manufacturing pose unnecessary financial risks? Production processes for biopharmaceuticals using mammalian cells still suffer from cellular and platform limitations compared to bacterial or yeast-based expression systems. How can we overcome limited growth, low productivity, and stress resistance, and higher operation expenses?
A 2015 study shows that the biopharmaceutical industry provided 8,182 kg of monoclonal antibody products, representing nearly $100 billion in revenue in 2013 (US, Canada, Europe, and Australia). While the role of biologics in treating human diseases has evolved dramatically over the past decade, so has the technology to manufacture and the role of the manufacturing process on the structure and activity of the molecule. Eventually, current market drivers in the biotech industry require process innovation to increase manufacturing flexibility and decrease COGs.
We are witnessing a proliferation of enabling tools, as analytical scientists have developed sophisticated techniques to decipher attributes critical to quality. In fact, N-linked glycosylation plays a crucial role in the efficacy of therapeutic proteins and is therefore considered as one of the major quality attributes. However, bioprocess conditions, media components, and scale-up issues can significantly influence the quality of a protein. System, bioprocess conditions, media supplements, as well as scale-dependent process characteristics, can have a decisive impact on process performance and product quality. Superior therapeutics with proven efficacy of various glycoengineered proteins has stimulated the development of novel optimized expression systems such as mammalian cells producing non-fucosylated antibodies. Controlling protein N-linked glycosylation tightly and other critical quality attributes (CQAs) during the manufacturing process thereby set new standards in bioanalytical throughput and precision. Besides, it is now becoming feasible to produce material rapidly for pharmacology, formulation, and toxicology studies without having to establish a stable cell line. At the same time, various production systems for glyco-optimized proteins, including yeast have already been engineered to produce the main steps of the human N-glycosylation pathway and enabled biobetter versions of therapeutic mAbs. While routine PTM optimization across the cell’s glycosylation machinery seems at far reach today, combining the expression from nonmammalian hosts with antibody glycosylation performed in vitro are promising. Continuous Bioprocessing can position the biotech industry to expand its commitment to serving even larger populations and unmet medical needs. Furthermore, an integrated continuous biomanufacturing (ICB) platform offers significant financial advantages due to multiple process intensification (such as smaller, fewer and more efficient unit operations, more flexible facilities, reduced turnaround time and increased automation) leading to hundreds of millions of dollars in savings.