Meet Your Match: How to Choose the Right Outsourcing Partner

Outsourcing is in vogue. The global pharmaceutical CDMO market accounted for $146.29 billion in 2023 and is set to increase to roughly $295.95 billion by 2033 with a CAGR of 7.3 percent, according to a new report by Nova One Advisor.

There is huge pressure to accelerate the development of increasingly complex drugs, but many companies lack the time, space, resources, and expertise for developing and commercializing their products in-house. Outsourcing partners can provide the specialized support, knowledge, and infrastructure needed to expedite the clinical and commercial processes without jeopardizing quality.

But the big question is, how do companies find the best-fit CDMO partner? There are many solution providers to choose from, but there are four traits that can never be emphasized enough:

• Quality. Quality is always your top priority. Every aspect of development and manufacturing – from equipment and staffing to processes and compliance – should focus on meeting stringent quality standards. You need to be confident that your CDMO is serious about quality. Make sure you partner can control expenses without compromising quality. This means using efficient methods, verifications, and non-destructive testing throughout the process to reduce risk.
• Experience. There are extensive benefits from working with experienced staff familiar with a variety of molecules, substance classes, and delivery formats. Many companies today are working on first-in-class or complex molecules. CDMOs with experience with a wide range of projects are more likely to be confident working on a new API.
• Flexibility. You will want your CDMO to align with your quality management systems, integrate with your teams, and communicate effectively. You need your CDMO parner to be flexible to meet your specific needs. CDMOs will have multiple clients, but how they work with one customer may not work for you. Hence, look for adaptability.
• Time to Market. To avoid delays, make sure your partner understands your milestones and project timelines. For example, will they be ready to fill and finish when needed?

All of these aspects may sound obvious, but they should never be overlooked. Always do a thorough evaluation. Never just choose your partner based on cost.

Other considerations before signing up are:

• Can this CDMO evolve with the needs of my company?
  • Think beyond current needs; look for a CDMO that can help meet both the immediate milestones and support throughout the entire drug product life cycle. Even better, look for a partner that is making investments in capacity now to allow room for expansion in the future.
• Are the communication style and project management capabilities a good match?
  • Any project requires open, two-way communication. Communication style should be apparent in your early discussions with a potential partner.
• Does the partner effectively manage its role within the supply chain?
  • A good partner will have the appropriate resources to procure materials and offer storage capabilities at a moment’s notice. As the supply chain continues to pose a challenge, working with a well-connected partner can prevent materials shortages that may cause project delays.

Once you’ve picked your partner, it's important to provide a detailed report covering the APIs, the stage of formulation development, method development and validation, technology transfer, and packaging. This information will help the CDMO to determine whether the molecule is fit for its facility and expertise.

Switching development and manufacturing partners can be a time-consuming and cost-intensive process. A careful, strategic choice can prevent many potential challenges downstream.

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