The five key risks of failing to select the right CDMO partner

The five key risks of failing to select the right CDMO partner

Partnering with the right contract development and manufacturing organization (CDMO) is critical throughout the entire drug development and manufacturing life cycle, from the initial discovery phase to successful commercialization. For oral solid dosage (OSD) and sterile drug product projects, selecting the ideal partner can significantly impact the success of your drug candidate, leading to faster time-to-market, cost savings and improved patient outcomes.

The consequences of not selecting the right partner

Failing to choose the right CDMO for this crucial relationship can have a cascading effect on the entire process. Here are some of the key risks:

• Delayed time to market

An unsuitable CDMO might lack the specific expertise, equipment or capacity to handle the project efficiently, causing bottlenecks and delays. Ineffective communication and collaboration can also impede progress, leading to missed milestones and extended timelines. 

• Quality issues

Inadequate quality systems or a lax approach to compliance can result in product quality problems, regulatory scrutiny and potential recalls, causing reputational damage and eroding patient and other stakeholder trust. 

• Regulatory compliance issues

Choosing the wrong CDMO can cause severe regulatory compliance problems. Poor data integrity, lack of validation, inadequate quality management and non-compliance with global regulations can lead to project delays, increased costs and even patient harm.

• Intellectual property (IP) risks

Unauthorized disclosure or use of confidential information can be the result of insufficient protection of intellectual property, potentially undermining the organization’s competitive advantage.

• Scalability and supply chain challenges
  
  A CDMO lacking the capacity or flexibility to scale production in line with your project’s needs can create supply chain disruptions and shortages. This can lead to missed market opportunities or an inability to meet patient demand, negatively impacting commercial success.

Unique product considerations

In the intricate landscape of OSD and sterile drug development, product sponsors must meticulously assess the unique characteristics of their projects and align them with the capabilities of potential CDMOs. Here are three critical considerations to take into account:

• Therapeutic area and technology specificity
  A CDMO with a strong track record and specialized capabilities and equipment in a specific area, such as OSD or sterile drug product, will be better equipped to handle the unique challenges and regulatory requirements.
  
  
• Development stage and project complexity

Considering the project’s stage and complexity, including formulation challenges, stability issues or specific regulatory requirements — and choosing a CDMO with a proven ability to handle such complexities — is vital.

• Scalability and future needs

It is crucial to anticipate the potential growth and future needs of the project and select a CDMO with the capacity and flexibility to scale production as the project progresses, from clinical trials to commercial launch.

By carefully evaluating these considerations in light of the specific project, sponsors can increase the chances of selecting a CDMO partner well-suited to their needs and able to contribute to the success of the drug development journey.

Overcoming development challenges

The right CDMO partner can be a game-changer in overcoming the challenges of product development and manufacturing. Their expertise, resources and collaborative spirit can streamline processes, mitigate risks and accelerate timelines, ultimately increasing the likelihood of success and enabling sponsors to focus on their core strengths and maximizing the value of the project. This ensures that innovative OSD and sterile drug products can reach patients waiting for life-changing treatments quickly.

To find out more about the key questions that product sponsors should ask potential partners before selecting the right CDMO for their unique OSD or sterile drug project, download our recent eBook.