In addition, advances in drug discovery are generating candidates of increasing complexity requiring manufacturing processes that are more expensive to build and run. Biotech companies are therefore forced to operate under a new paradigm requiring them to understand and control the cost of manufacture (Cost of Goods) from early in clinical development.

For small biotech companies focussed on drug discovery and early phase clinical development the economics of commercial scale manufacturing may appear unimportant in comparison to their short term development goals. There is however, the opportunity to use market intelligence and manufacturing cost analysis from early in development to inform strategic decisions. Benefits can be gained irrespective of the development and commercialisation strategies under consideration, and analysis can provide a competitive advantage when defining and evaluating these options.

BPS has helped a number of biotech companies understand their manufacturing options including in-house production, product licensing and outsourcing. Examples of the types of problem we have helped to solve include:

• Economic screening of lead candidates
• Defining objectives and milestones for process development
• Assessing the availability and pricing of contract manufacturing services
• Evaluating alternative process technologies taking into account the impact of time to market
• Calculating a detailed Cost of Goods breakdown to be used in negotiation
• Identifying process and project risks

BPS consultants use proprietary market information in combination with economic modelling to provide insight into manufacturing issues. Our market information includes proprietary datasets of biopharmaceutical clinical trials and contract manufacturing capacity in Europe and the US. Our process-based economic models use proprietary datasets of equipment and material costs, cost factors derived from benchmarking and novel sizing algorithms derived from process simulation studies. We are able to provide a good understanding of the key assumptions, uncertainties and risks in both the process design and costs.

In addition, BPS is able to offer biotech companies engineering expertise in process and facility design and scale-up. On a number of occasions we have helped companies investigate the impact of new equipment technologies on their facility design. For large biotech companies manufacturing their own products we are able to offer process simulation tools to be used in logistical analysis, materials and resource planning, and plant scheduling.