Over the last twenty-five years, contract manufacturing organizations (CMOs) have been playing an increasingly important role in the pharmaceutical industry. A November 2016 study from Industry Standard Research Reports reveals that life sciences companies now outsource a full two-thirds of their manufacturing activities to CMOs.1 For small commercial companies, that figure is even higher—up to 80% in 2015—while contract manufacturing of drugs for developed markets increased by 6% to reach a total of $16.5 billion in 2013–2014.2
Moreover, contract manufacturers are seeking to further expand their role in the industry by providing a wider range of services for their clients. As life sciences companies rely ever more heavily on CMOs, it is important they utilize modern software to streamline communications and ensure that the relationship produces the results that the company is looking for.
Making the Most of Business Relationships with Contracting Manufacturing Organizations
Pharmaceutical companies are increasing their use of contract manufacturing organizations for a variety of reasons. These collaborations have the potential to cut costs, improve process efficiency and decrease time to market. As the relationships between CMOs and their clients change, it is important that these relationships hinge on a few key areas in order to ensure maximum productivity and effective collaboration:
● Streamlined Communications Between Organizations
Pharmaceutical companies can adopt several different outsourcing models depending on capability and need. For instance, some companies manufacture active pharmaceutical ingredients in-house while relying on CMOs to manufacture final drug products. Others are choosing to outsource both operations. There are also cases in which the company manufactures most drug products but hires CMOs to produce specialty formulations that the company lacks the capacity or experience to handle on its own.3 With the growing complexity of these relationships, it is critical for pharmaceutical companies and CMOs to collaborate effectively in order to ensure manufacturing efficiency and protect against product variability.
● Improved Process Development
Rather than just providing manufacturing services, it is becoming more common for CMOs to also offer development support and enhanced drug delivery technologies like proprietary devices and specialty formulations. While these innovations can help pharmaceutical companies better meet the needs of patients, the integration of CMOs into more areas of R&D demands close collaboration at every step of the development process. Also, to guarantee that all aspects of the drug product work well together, quality assurance of manufacturing processes is essential. It is important to implement a solution that not only allows for information sharing, but also collects and contextualizes quality data so that processes can be monitored and adapted as necessary. That way, no matter how CMOs contributed, all parties can feel confident in the final product.
● Reduced Regulatory Risks
While CMOs have been most successful in North America and Europe so far, emerging markets like Japan are experiencing faster growth in pharmaceutical manufacturing, so more CMOs are looking to expand their operations in these areas. As a result, global life sciences companies will have more opportunities to work with them in these countries. This can lead to an increase in the availability of certain therapeutics in emerging markets, but it is important to note that regulatory standards may vary between countries. Constant monitoring of manufacturing processes guarantees that potential irregularities are flagged before they become a major problem for life sciences companies and CMOs.
Companies around the world should be investing in ways to keep track of compliance risks in different locations.
● Reusable Past Knowledge
One of the most effective ways for a life science company to reduce the amount of time it takes to bring a new drug to market is to maximize institutional knowledge in order to avoid making the same mistake twice. Process developers will be more likely to get it right the first time if they use specialized software to capture process data and provide quick access to previously collected information. The ability to aggregate and reuse data is becoming even more important as life sciences companies develop new relationships with CMOs, since the archived information will allow developers to figure out how to optimize processes in ways that account for the changing roles of CMOs in the development and manufacturing processes.
Regardless of the extent of the relationship between a life science company and its contract manufacturing organization, new solutions should be implemented to help them meet the challenges of working together on process development and drug manufacturing. By streamlining data analytics and information, modern software facilitates the seamless integration of CMOs into any aspect of the development or manufacturing process.
1 “Contract Development and Manufacturing Outsourcing Models,” 2016, http://www.isrreports.com/reports/contract-development-manufacturing-outsourcing-models/
2 “What’s Next for the CMO Industry?” August 1, 2015, http://www.pharmtech.com/what-s-next-cmo-industry
3 “Two-thirds of pharmaceutical manufacturing is outsourced; preferred providers pick up largest, share,” November 15, 2016, http://www.marketwired.com/press-release/two-thirds-pharmaceutical-manufacturing-is-outsourced-preferred-providers-pick-up-largest-2175929.htm