Dealing with biologics production uncertainty

The biologics development and approval process for pharmaceutical companies around the world is typically long and complex, which increases the risk of inaccurately forecasting demand


To better understand demand forecasting challenges, a survey of pharmaceutical and biotechnology industry leaders from North America and Europe was conducted by business intelligence firm ORC International and sponsored by Patheon, a leading global provider of high-quality drug development and delivery solutions to the pharmaceutical and biopharma industries.* The research found that demand forecasting poses a significant challenge when companies are planning biologic drug substance production. Overestimating demand can lead to higher per unit cost and disposal expenses, while underestimating demand can result in missed market opportunity and negative reputational consequences for 
the company.

According to survey responses, the timeframe between the end of Phase II and biologics substance manufacturing can range from one to five years, and one executive noted that contract manufacturers are locking in business seven years in advance. With these extended timelines, biologics companies have to make assumptions on patient populations, demand and manufacturing capacity years in advance of production to reserve capacity. Because of the greater complexities involved in manufacturing biologics, inaccurate demand forecasts for biologics can cause significantly more problems for companies as compared to small molecules.

Strategies that allow for more flexible manufacturing
Companies are employing various strategies, either at contract development and manufacturing organizations (CDMOs) or internally, to gain more flexibility in their manufacturing processes. The most commonly mentioned strategy that appealed to biotechnology executives was single-use technology. Using disposables for all the product contact components is a straightforward and quick process that eliminates the need for cleaning validation. These single-use components have successfully increased flexibility in recent years, allowing a faster turnaround for companies.

Another technique available to the industry is dual sourcing (especially for commercial products)—which combines higher capacity with risk reduction from process upsets at a location.

A third technique is multiplexing, which allows for reproducible, scalable progress from smaller to larger capacities. Reactors are added or removed to accommodate demand without the need to revalidate the process because of leveraging single-use technologies. Multiplexing allows for a single-solution provider, site and suite to scale as needed.

A fourth technique is modular designs, which allow 
for production systems to be interconnected for varying production campaigns.

Companies developing biologics are faced with many challenges in planning for their clinical and commercial drug supply needs—challenges that stem from the long product lead times that require companies to plan up to two years in advance and an industry-wide lack of capacity. The stakes in the biopharmaceutical industry are high and misalignment of demand forecasts can threaten product success and even company reputation. Among the key unmet needs expressed by executives interviewed is greater capacity among CDMOs and greater flexibility in manufacturing processes. Both sponsor companies and their partner CDMOs are now implementing various measures to instill more flexibility into their manufacturing processes, including single-use parts, dual sourcing and modular design. Sponsor companies are turning to CDMOs for their deep expertise in biologic production and their use of specialized technologies and human resources, with the expectation that CDMOs can help them manage their development timelines and costs, while limiting their liabilities.

Partnering with a CDMO provides pharmaceutical companies with the facilities, equipment and process technology expertise needed for operations and risk management, further helping clients find innovative solutions to their challenges. This strategic partnership also offers companies the aforementioned advantage of more flexible manufacturing offerings that accommodate the variability factor and help mitigate risks that accompany inaccurate demand forecasts. Such flexible manufacturing services, like those provided by Patheon, complement the traditional outsourcing service model through scalable capacity, allowing clients to increase and decrease capacity as needed.

*The paper is available online at: [http://www.patheon.com/en-us/Ideas-in-Action/Material-Details?materialid=59]

ABOUT THE AUTHOR
Steve Lam, PatheonSteve Lam is senior vice president of Patheon’s Biologics Unit. For the past 18 years, Lam has served as vice president of operations for Amgen, where he led a company-wide transformation initiative driving robust quality management processes and operational excellence. He brings to Patheon more than 25 years of leadership experience in biopharmaceutical operations. He has specific expertise in protein manufacturing, CGMP compliance, quality systems and technology transfer.

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