Pharmaceutical companies are looking for outsourcing partners with the necessary equipment, facilities, expertise and resources they need to avoid common manufacturing pitfalls that may prevent the success of their drug.
Currently, the outsourcing market is extremely fragmented – from smaller, specialized contract manufacturing organizations (CMOs) and full-service, end-to-end contract development and manufacturing organizations (CDMOs), to ‘pure play’ and embedded outsourcing models. Clearly, there is a wide range of contract manufacturing service providers to choose from.
Despite the fact that the embedded CDMO business model has been practiced for many years, there still may be gaps in the industry’s understanding of how embedded CDMOs operate, and the advantages such organizations can offer drug owners and pharmaceutical innovators working to bring their medicine to patients.
In this article, I will explore the changing outsourcing landscape. In addition, I will also explain the embedded CDMO model, correct some of the common misconceptions about embedded CDMO relationships and review the advantages of working with this kind of organization.
The Changing Outsourcing Landscape
Bringing new medicines to market as efficiently as possible is vital for pharmaceutical organizations today. As the outsourcing market becomes increasingly competitive, the ability to accelerate a drug’s speed to market is especially important for companies looking to lead in their categories while being profitable. For example, Reuters has estimated that the outsourcing market will grow at a rapid CAGR of 7.24% from 2018 to 2022. Most pharmaceutical companies now understand that CDMOs offering quick turnaround times and high quality manufacturing will likely bring the greatest success.
Embedded CDMOs are proving popular because of their ability to accomplish these requirements through a solid combination of experience and highly developed business and operational acumen.
Operating within the larger ‘Big’ pharma context, embedded CDMO partners have access to the facilities, equipment, systems, resources and expertise of some of the most well-established and well-known pharmaceutical companies leading the industry today.
Having the ability to tap into the valuable resources of larger organizations, embedded CDMOs can manufacture APIs and drug products in a reliable and efficient way. They can, for example, leverage the experience of the larger pharmaceutical company to anticipate potential problems that could occur during the production process and are well equipped to handle the scale-up and tech transfer process of complex compounds. This provides an opportunity to mitigate the potential for issues arising during the journey from Phase II to commercialization, saving both time and money in many cases.
Navigating the Complex Regulatory Space
Companies working in industries as stringent and as complex as the pharmaceutical industry need to have a clear and robust understanding of the rules and regulations that apply to their products in various regions.
Good practice (GxP) quality guidelines and regulations, for example, are constantly evolving and can vary from region to region. A sound understanding of the regulations for intended markets is needed to ensure the best chance for a successful regulatory application approval in those markets.
The changing approach to data integrity is a good example of this. In recent years, guidance on data integrity has been issued by the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the World Health Organization (WHO) and the European Medicines Agency (EMA), among others.
While fairly consistent, there are some nuances to note. The UK’s Medicines and Healthcare product Regulatory Agency’s (MHRA) ‘GxP’ Data Integrity Guidance and Definitions (2018) defines data integrity as: “the degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, so that they are attributable, legible, contemporaneously recorded, original (or a true copy) and accurate (ALCOA). Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.”
This is a huge leap compared with the 2015 definition from the same agency: “The extent to which all data are complete, consistent and accurate throughout the data lifecycle.” The addition of the ALCOA principles required manufacturers to adopt new data management procedures and quality management systems that were unfamiliar to many in the industry.
CDMOs are typically considered an extension of the pharmaceutical company. To keep on top of the various regulations and their complexities within each country and to ensure that production is compliant, pharmaceutical companies choose outsourcing partners that have a sound knowledge of the global markets and can offer comprehensive support when it comes to regulatory compliance. Since embedded CDMOs can use the expertise and resources of their parent company, staying on top of evolving regulations for a given market becomes more efficient. This allows the embedded CDMO to advise their customers on the varying regulations in each country and offer important advice during drug development and manufacture.
Adapting to Development and Manufacturing Trends
In an ever-changing industry, it is also important for pharmaceutical companies to choose CDMOs that have the finances to sustain and continuously improve the facilities, capabilities and resources needed for successful manufacturing.
The manufacture of highly potent drug products like opioids or hormones is complex, highly regulated and often require sophisticated containment and segregation strategies. Associated costs can climb quickly, prompting many companies to look for strong partners that have specific experience with their complex molecules and the equipment and expertise already in place to do the job.
In addition to this, demand for small molecule API manufacturing is also on the rise as new, more innovative, complex, first-in-class medicines are being developed to address unmet patient needs.
This work often requires the expertise, operational excellence and specialist technologies that only certain experienced outsourcing partners can provide. There are many advantages to using an embedded CDMO to manufacture small molecule APIs. For example, embedded CDMOs typically have mastered the tech transfer, process optimization and scale-up of their own drugs and can apply similar techniques and principles to customer compounds.
With its own portfolio of pharmaceuticals, embedded CDMOs continually invest in their manufacturing sites to maintain them at the cutting edge of technology and staffed with top-notch talent.
Scaling-Up
Scale-up capabilities are another important consideration when choosing a CDMO. Most APIs and drug products may behave differently in larger manufacturing environments compared with laboratories, so organizations are carefully choosing outsourcing partners who are best placed to take their product through to commercial manufacture.
Most importantly, companies are looking for CDMOs that can anticipate issues before they have an impact on their product development timelines. CDMOs should have experts in place to identify risks and prevent problems that could occur when scaling up a drug, which will help avoid any time-consuming delays that could impact the GMP release of the batches.
It is important to note that, while other CDMOs may base new technology investments simply on keeping up with market trends, embedded CDMOs have built up specialist expertise and invested in the appropriate technology over time. This in turn signals they have experience and the right expertise to ensure successful delivery of customer projects.
In short, quality, reliability and commercial manufacturing success are dependent on the time, money and resources contract suppliers invest in their people, science and facilities.
A Final Note…
The outsourcing landscape is a very complex one and for biotech and pharmaceutical companies, choosing the right partner requires careful consideration. CDMOs with the capabilities and expertise in place to ensure that scale-up, regulatory compliance and IP protection can all be implemented properly, position themselves well in the market.
Going into the next decade, it is likely that more companies will embrace the embedded model as a strong viable option to bring their drug to market. However, these and other performance attributes can only emerge with effective collaboration, with teams organized and experienced enough to deliver the kind of personalized, professional services that sustain better drug commercialization for the long run.
References
- https://www.reuters.com/brandfeatures/venture-capital/article?id=40498
- https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/687246/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf
About the Author
JoyL Silva, General Manager of Pfizer CentreOne, is responsible for leading the Pfizer CentreOne team to achieve its business goals. Silva brings a wide range of experience from within Pfizer to the company’s embedded CDMO operations. Silva has a proven track record of delivering results in complex markets through her 20 years at Pfizer spanning customer facing sales roles, commercial business and key account management leadership, strategy, and global operations.