The current financial crisis is adding to the pressure on the pharmaceutical industry to reduce the costs of new drugs. For example, recently the UK's National Institute of Clinical Excellence (NICE) complained about the industry making excessive profits from new treatments.1 Concerns about the balance between costs and benefits have spread to the US and these will be high on the agenda of the Obama administration as it considers healthcare reforms.2
Although manufacturing costs are not the only cost contributor to the total drug price, they are a significant (estimated to be 10% to 20% of the sales price) and a growing component.3 This, coupled with the large capital expenditures required for these facilities, means that the issue of manufacturing costs is rapidly assuming visibility and prominence. Over the last decade, Biopharm Services has observed a major trend in companies wanting to have a better understanding of manufacturing costs. This is particularly the case amongst large biopharmaceutical companies, who want to understand manufacturing costs early on in development. Costs are now one of the key criteria for evaluating process options.
So what does this mean for disposable technologies? In an earlier column, we talked about how to evaluate the cost of disposable technologies.4 In this article, we will look at the various effects of implementing a wide variety of disposable technologies on manufacturing costs. We will also discuss how the costs vary with scale, vendor, and process. This is important when designing cost-effective operations.
We are basing this analysis on a cost of goods (CoGs) model using Biopharm Services' BioSolve cost-model package. This model allows us to quickly evaluate options with methods that are transparent and available for external scrutiny. Figure 1 describes the modular structure of the model. Its most important feature is the ability to modify the process definition, including technologies, and to propagate those changes immediately throughout the model. For this analysis, a commercially relevant monoclonal antibody (MAb) production process was used as the basis for evaluating disposable technologies.5 Within the BioSolve framework we have the ability to decide whether to include or exclude specific technologies for particular applications. In this exercise, we will evaluate the following single-use technologies:
- mixers for media and buffer preparation
- hold bags for product and buffers
- membrane absorbers.
The base case for the comparison is a 2,000-L production bioreactor scale with three bioreactors feeding one purification train, with all systems in stainless steel. The cost data for the main cost categories used for the analysis comprise the following (note all costs are list price and do not include discounts):
- Raw-material components based on standard commercially available raw-material pricing
- Capital equipment costs derived from vendor data from recent projects. These data are used to estimate equipment costs. The accuracy of the capital project predictions has been checked independently by DSM.6
- Consumable pricing for filters, disposables systems, and resins. These are average prices sourced from multiple vendors.
- Labor costs are based on standard US rates for the Massachusetts area.