Early-phase drug product development and manufacturing are crucial steps in transforming promising drug candidates into viable, life-changing therapies. In the fast-paced drug development landscape, collaboration between biopharmaceutical companies and Contract Development and Manufacturing Organisations (CDMOs) has become indispensable for managing the complexities of this intricate process. This article will delve into the vital role CDMOs play in mitigating risks and accelerating early-phase drug development, from formulation to large-scale production.
The Evolution of CDMOs
CDMOs have evolved to meet the growing demand for specialised expertise, capabilities, technologies and infrastructure in the pharmaceutical industry. With the CDMO market size estimated at USD 238.47 billion in 2024, and expected to reach USD 330.36 billion by 2029, growing at a CAGR of 6.74% during the forecast period (2024–2029),1 the vital role that CDMOs play in the biopharmaceutical ecosystem is clearly evident.
Historically, pharmaceutical companies managed all aspects of drug development and manufacturing in-house. However, as the industry has become more complex and competitive, CDMOs have become an integral part of the supply chain, offering integrated and strategic solutions to their partnering companies.
A prevalent trend in the CDMO landscape is the preference for outsourcing to CDMOs that provide end-to-end solutions, supporting the entire lifecycle of a drug product from pre-formulation and formulation development, analytical method development to scalable manufacturing, packaging, and launch. The CDMO’s expertise and dedicated focus on specific aspects of drug development make them valuable partners, particularly in the early phases when flexibility, speed, and specialised knowledge are crucial.
Benefits of Partnering with CDMOs in Early Drug Development
1. Specialised Expertise:
CDMOs offer specialised expertise, established quality systems, and in-depth regulatory compliance knowledge. Their exposure to a diverse range of projects results in a wealth of insight and combined experience across all areas of product processing. This expertise is particularly valuable during early phase development, where unique challenges of different drug candidates necessitate tailored solutions. CDMOs can provide critical insights into formulation strategies, analytical methods, and regulatory considerations that may not be readily available within a biopharmaceutical company, which can help streamline the development program, saving time and money. Additionally, the CDMO will continue to evaluate and redefine the program throughout the lifecycle of the drug product.
2. Accelerated Development Timelines:
One of the key advantages of partnering with a CDMO is the potential for accelerated development timelines. With state-of-the-art facilities, advanced technologies, and extensive technical expertise, CDMOs can streamline processes and expedite development. This is particularly crucial in the early phases, where speed to market can greatly influence a drug’s success. Leveraging a CDMO’s existing infrastructure and expertise can lead to faster formulation development, analytical method validation, and overall progress through the development pipeline.
3. Cost Efficiency:
Collaborating with a CDMO can provide significant cost advantages, especially for biopharmaceutical companies facing the uncertainties of early phase development. CDMOs use technological innovations to optimise production efficiency, offering analytical and manufacturing technologies at the appropriate scale to help manage operational and project costs. Typically operating on a fee-for-service model, CDMOs allow biopharmaceutical companies to optimise costs by paying only for the specific services needed at each stage or project milestone. CDMOs are used to working with very limited amounts of API and this knowledge can be leveraged to reduce cost by optimising the use of the available API. This flexibility is particularly beneficial in early phase development, where adjustments to the development plan may be necessary based on evolving data and regulatory feedback.
