On average, the cost of bringing a biologic therapy to market is $2.8 billion with a timeline of 10 years or more. As the biologics industry continues to grow at a rapid pace and biologics become more technologically advanced, manufacturing is increasingly diverse and complex. The industry is faced with the challenge to adapt to the changing production requirements and market conditions. In our previous posts, Private-Public Partnerships to Drive Manufacturing Improvements and Manufacturing Solutions, Where Small-Scale is Full-Scale and market reports (brief report and full report), we highlight ways in which the industry is continuously working to find flexible biomanufacturing solutions that drive down costs and time to market.
Two Problems Create a Bottleneck for Manufacturing Capacity
At the 2016 BIO International Convention, panelists discussing The Changing Landscape for Biomanufacturing: Product Strategies, Market Environment and Biomanufacturing Dynamics, offered their insight on biomanufacturing solutions to help reduce lead times and bring these promising therapies to more patients. Steve Lam, Senior Vice President at Patheon summarized the problem. Flexibility in biomanufacturing solutions is being driven in part by:
- inaccuracies in demand forecasting and
- increasing competition for available capacity
Lam went on to say that half of demand forecasting suffers from over-estimation by 25%. This particularly concerns the estimation of volume requirements for production. Decreases in volume requirements for biologics is likely a consequence of technological and process advancements; in fact, 50% of all biologic products in development will require 5kL or smaller. While over-estimating volume requirements is arguably less detrimental than under-estimating, it can have serious consequences for both operational efficiency and the bottom line. Unfortunately, accurate forecasting is particularly challenging for biologics given long lead times, short shelf lives and complex supply chains. But, being accurate is critical to producing more cost effective therapeutics.
With respect to manufacturing capacity, Patti Seymour at BioProcess Technology Consultants said that just ten companies retain more than 50% of manufacturing capacity. Contract development and manufacturing organizations (CDMOs) provide just 10%. Consequently, small companies that do not have manufacturing capabilities or connections face very long lead times. They may need to reserve manufacturing facilities 12-18 months in advance or partner with larger product companies that already have access to manufacturing facilities.
Options Exist for Flexible, Customized Manufacturing
Some models may provide flexible biomanufacturing solutions and customization that companies need to more quickly bring their therapies to market.
Panelists emphasized that by having a plan in place for commercializing biologics earlier rather than later in development will only streamline the process. “Companies need to have conversations with product development teams well before commercialization,” said Lam. “Traditionally companies solve technical problems first, but what they need to do is solve the commercialization piece first since the technology piece is typically solved faster than commercialization aspects.” Andrew Mica, Senior Director Global Supply Chain at Biogen Idec, chimed in.
By having a flexible and customizable manufacturing model for scale up/out during commercialization, companies will produce biologics in a more time and cost effective manner. The result? Therapies can reach patients faster.