The business impact of an integrated continuous biomanufacturing platform for recombinant protein production

This paper presents the application of a decision-support tool, SIMBIOPHARMA, for assessing different manufacturing strategies under uncertainty for the production of biopharmaceuticals. SIMBIOPHARMA captures both the technical and business aspects of biopharmaceutical manufacture within a single tool that permits manufacturing alternatives to be evaluated in terms of cost, time, yield, project throughput, resource utilization, and risk. Its use for risk analysis is demonstrated through a hypothetical case study that uses the Monte Carlo simulation technique to imitate the randomness inherent in manufacturing subject to technical and market uncertainties. The case study addresses whether start-up companies should invest in a stainless steel pilot plant or use disposable equipment for the production of early phase clinical trial material. The effects of fluctuating product demands and titers on the performance of a biopharmaceutical company manufacturing clinical trial material are analyzed. The analysis highlights the impact of different manufacturing options on the range in possible outcomes for the project throughput and cost of goods and the likelihood that these metrics exceed a critical threshold. The simulation studies highlight the benefits of incorporating uncertainties when evaluating manufacturing strategies. Methods of presenting and analyzing information generated by the simulations are suggested. These are used to help determine the ranking of alternatives under different scenarios. The example illustrates the benefits to companies of using such a tool to improve management of their R&D portfolios so as to control the cost of goods.

Decision-support tool for assessing biomanufacturing strategies under uncertainty: stainless steel versus disposable equipment for clinical trial material preparation.

This chapter summarizes the recent developments of biopharmaceutical production using mammalian cell culture, and focuses on monoclonal antibodies (MAbs), which is the most dominant and most rapidly developing sector in the biopharmaceutical industry, and its large-scale production the most established. Two expression vector systems dominate antibody production in mammalian cell culture, one based on dihydrofolate reductase (DHFR) genes and the other on glutamine synthetase (GS) genes. To improve outgrowth and transfection efficiency, transfection is predominantly performed in serum-containing media, but using host or parental cell lines preadapted to grow in suspension and serum-free media reduces adaptation times and increases the likelihood of reaching high cell densities and high product yields in serum-free suspension culture. Apoptosis is induced by various chronic insults and is mediated by several mechanisms. Various strategies were implemented to inhibit apoptosis, including the prevention of nutrient limitation by fed-batch operation, which can delay the onset and extent of apoptosis, and engineering of resistance into the cell line, such as the regulatory Bcl-2 family of proteins, which affect the activation of apoptosis pathways in cells. Novel technologies such as enhanced expression systems, automated screening methods, cell line engineering, improved process monitoring, and disposable apparatuses are leading to more productive and efficient production of biopharmaceuticals by mammalian cell culture.

Mammalian Cell Culture for Biopharmaceutical Production

Process economic drivers in industrial monoclonal antibody manufacture

Single-Use Equipment in Biopharmaceutical Manufacture: A Brief Introduction

Quantitative economic evaluation of single use disposables in bioprocessing

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Quantitative economic evaluation of single use disposables in bioprocessing