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The journey to market for innovative therapies is fraught with difficulties. To deliver critical therapies to patients in need, biotech and pharmaceutical companies often face challenges as they transition their products from early-stage development to commercialization. Major hurdles include the need for extensive research and development, substantial financial investments, rigorous regulatory approvals and the development of robust manufacturing capabilities.
Increasingly, drug developers are seeking the support of contract development and manufacturing organizations (CDMOs), including “integrated” CDMOs. By leveraging their advanced manufacturing capabilities and scientific expertise, integrated CDMOs within leading pharmaceutical companies are helping their customers streamline drug development, mitigate risks and accelerate time-to-market for innovative therapies.
In this article, Rick L. Knight, Global Head, Strategic Account Management at Pfizer CentreOne, explores the challenges faced by the pharmaceutical industry in an ever-changing landscape and outlines why CDMOs are an increasingly strategic option overall. He also explores the distinct benefits integrated CDMOs can offer to help their clients overcome challenges and bring vital therapies to the patients waiting.
The changing outsourcing landscape
Despite well-mapped therapy commercialization routes, the drug development and manufacturing process remains complex. Biotech and pharma companies of all sizes are likely to face many challenges as their project progresses toward commercialization, leading to a need for experienced guidance. As a result, many of these companies are seeking support from expert CDMOs to overcome various hurdles:
- Capacity constraints and cost considerations
Many biotech and pharma companies outsource to CDMOs to avoid the significant capital investments required for building internal manufacturing facilities and hiring specialized staff. Outsourcing allows them to access additional capacity and expertise cost-effectively, enabling them to focus on their core competencies such as drug discovery and development. - The need for specialist expertise
As the pharmaceutical pipeline shifts toward more complex biologics, including antibody-drug conjugates (ADCs), cell and gene therapies and other innovative complex modalities, there is an increasing need for specialized expertise and advanced manufacturing capabilities that many drug developers lack in-house. CDMOs with experience in these cutting-edge areas are in high demand to navigate regulatory complexities and provide the necessary technical expertise. - Meeting increasing demand for speed to market
Biotech and pharma companies are under constant pressure to stay ahead of the competition, maximize patent protection, reduce costs, address unmet needs and meet investor expectations. As a result, drug developers must implement strategies that can accelerate timelines and shorten time-to-market. This includes working with a dedicated CDMO partner with platforms and processes built with speed in mind. - Overcoming supply chain challenges
The increasing complexity of drug development and manufacturing combined with the heightened risk of supply chain disruptions in recent years has led biotech and pharma companies to seek support from CDMOs prioritizing supply chain resilience. CDMOs offering robust strategies such as leveraging advanced data analytics, implementing flexible manufacturing capabilities, expanding service offerings and fostering strategic partnerships are becoming invaluable partners. These capabilities not only mitigate supply chain risks but also enable companies to adapt swiftly to changing market dynamics and regulatory requirements, ensuring the uninterrupted flow of critical drug products to patients worldwide.
With these challenges in mind, it is not surprising that increasing numbers of biotech and pharma companies are seeking the support of CDMOs. In a recent report, only a minority of biologics were found to be manufactured entirely in-house. The percentage of mammalian cell culture platforms manufactured exclusively in-house declined from 57.6% in 2006 to 29.7% in 2023, indicating an increasing reliance on CDMOs (1). Consequently, the global CDMO market is expected to grow at an annualized rate of 7.29% to 2028, driven in part by the expansion of the biotech sector (2).
Integrated CDMOs and their distinctive benefits
Recognizing the potential of the growing and diverse CDMO market, leading pharmaceutical companies have initiated innovative measures. This has resulted in the emergence of a distinctive class of CDMO: the integrated CDMO, one embedded in a leading pharmaceutical company.
Integrated CDMOs operate as a self-contained enterprise existing within a larger pharmaceutical company. For decades, these pharmaceutical innovators have coped with shifting markets, patent expiries and the challenges of developing and manufacturing pharmaceuticals. As a result, integrated CDMOs offer access to the capabilities, resources and expertise of the parent pharma organization, often across a global network of sites, potentially providing more distinct benefits to their biotech and pharma clients than their pure-play CDMO counterparts. These additional customer benefits can include:
Long-established supplier relationships
Innovative pharmaceutical companies with integrated CDMOs have an extensive portfolio of products across multiple therapeutic areas. A broad portfolio and experience supporting a wide range of therapies result in numerous supplier relationships for drug substances (DS) and primary and secondary packaging components. These suppliers are subject to the integrated CDMOs’ internal quality systems, having undergone audits and evaluations. As a result, long-established supplier relationships can be leveraged to meet the needs of the CDMO’s customers and deliver high-quality therapies to patients effectively.
Access to specialized facilities and capacity
Leading pharmaceutical companies invest heavily in cutting-edge technologies and state-of-the-art facilities to support their own drug development and manufacturing activities. As integrated CDMOs operate within larger pharmaceutical companies, they have access to these innovative facilities, equipment and systems developed over many years that can be used to help meet their customers’ unique needs. These include optimal scale-up strategies, innovative synthesis methods and processes developed with extensive stability insights.
Thus, integrated CDMOs can leverage the resources of the larger organization to benefit their customers, helping to anticipate and mitigate potential issues during scale-up and tech transfer, and optimize processes while enhancing time and cost efficiencies.
Broad expertise and experience
Collaborating with an integrated CDMO enables customers to directly access the same highly skilled personnel and cutting-edge science that the parent organization utilizes to introduce groundbreaking innovations to the market. This seamless integration of expertise and technology is especially valuable in emerging therapeutic areas like cell and gene therapy, where rapid advancements and complex manufacturing processes demand specialized knowledge and state-of-the-art facilities. By partnering with an integrated CDMO, biotechs and pharma companies can leverage this shared pool of talent and resources. This can be used to accelerate their development timelines, navigate regulatory complexities and, ultimately, bring life-changing therapies to patients faster.
Having access to a broad spectrum of expertise is also important for the development and manufacturing of other complex biologics like antibody-drug conjugates (ADCs). Successfully producing these innovative therapies requires extensive knowledge of antibody engineering and selection, linker chemistry and payload selection, conjugation chemistry and analytical characterization, as well as specialized facilities to handle highly potent compounds.
Regulatory experience and quality systems expertise
Good practice (GxP) requirements are constantly evolving and vary across regulatory agencies, requiring continuous updates and investment in compliance. Integrated CDMOs often lead this commitment to continuous improvement, providing a competitive advantage to their customers in demonstrating compliance. They ensure the highest quality standards, with some CDMOs manufacturing external and internal active pharmaceutical ingredients (APIs), DS and drug products (DPs) alongside one another. This can further offer customers peace of mind that their product is in safe hands.
As part of a larger pharmaceutical company, integrated CDMOs can offer their customers a deep understanding of global regulatory requirements. This expertise can help anticipate regulatory challenges and implement creative strategies to ensure compliance, avoiding costly delays. With a legacy of successful campaigns, integrated CDMOs can offer best-practice regulatory support. They can also ensure strategies for chemistry, manufacturing and controls (CMC) filings and regulatory affairs that can withstand changes in the future.
A promising future with integrated CDMOs
Growing demand for innovative therapies, complex manufacturing and regulatory processes, and the need for efficient and reliable drug development, suggest that drug developers will continue to rely even more on the expertise and experience of integrated CDMO partners, over that of pure-play CDMOs.
By being part of larger pharmaceutical organizations, integrated CDMOs can often offer customers the same advantages of speed, service, reliable supply chain, mature quality systems and continuous improvement of the parent organization. Thus, integrated CDMOs can act more as strategic partners, guiding a customer’s projects faster and more effectively from development to patients waiting — because for the patient, time is life.
REFERENCES AND NOTES
- https://www.outsourcedpharma.com/user/edit/account
- https://www.dcatvci.org/features/the-cdmo-cmo-report-the-year-ahead-in-bio-pharma-outsourcing/
