Choosing a CDMO Partner: 7 Key Factors to Consider

Bachem, Swiss peptide and oligonucleotide manufacturers, explain the top considerations for pharmaceutical companies when selecting a CDMO

The process of selecting a Contract Development and Manufacturing Organization (CDMO) can be a turning point in pharmaceutical development. The right CDMO can make the difference in strengthening manufacturing capabilities, ensuring regulatory compliance, and facilitating the timely delivery of products to market.

To successfully navigate this process, companies must consider a range of essential criteria when choosing potential CDMO partners, ensuring alignment with both operational and strategic objectives. Below are the key factors to guide the decision-making process.

1. Industry experience and technical expertise

The complexity of pharmaceutical manufacturing demands a CDMO with substantial experience and proven expertise. CDMOs with a history of specialist support in Active Pharmaceutical Ingredient (API) production can bring a wealth of knowledge to project management, CMC strategy, and more.

An ideal CDMO partner demonstrates a comprehensive understanding of the regulatory landscape, backed by a strong track record of regulatory compliance. Case studies based on relevant successful projects can help demonstrate their competence and reliability, as well as their understanding of current regulatory requirements.

2. Robust project management

Seamless execution of pharmaceutical manufacturing projects is dependent on effective project management. The right CDMO should offer dedicated project managers who act as a point of contact with your team, ensuring aligned and coordinated collaboration.

Seek out partners who use project monitoring tools and carry out regular status meetings to update stakeholders on the project’s progresses, risks, and next steps. Clear communication and documentation protocols further ensure transparency and alignment at every stage of the manufacturing process.

A strong partnership is built on open and frequent correspondence to ensure all project objectives are met efficiently and effectively, while consolidating a foundation of trust.

3. Comprehensive support across development stages

The pharmaceutical development process — from process development to commercial manufacturing — requires end-to-end support. A reliable CDMO will provide expertise in critical areas such as process optimization, analytical method development, scale-up, and validation.

4. Commitment to quality and compliance

Quality is critical in the development of APIs. A CDMO must have robust quality assurance systems that adhere to Good Manufacturing Practices (GMP) and other regulatory standards. Their quality frameworks should include validated analytical methods, stringent documentation practices, and efficient processes for monitoring and managing deviations.

Assessing their approach to process validation, quality control, and equipment qualification can provide insights into their ability to consistently deliver products that meet the required specifications. Their quality systems should guarantee consistent products that meet your exact specifications, batch after batch.

5. Flexibility and customization

Each manufacturing project is unique, requiring tailored solutions to meet specific goals. The ideal CDMO should demonstrate flexibility in adapting to your needs, through offering tailored solutions for manufacturing processes, timelines and specialist project management approaches.

This adaptability must be balanced with a firm commitment to maintaining quality and regulatory compliance, ensuring that your requirements are met without compromising on standards.

6. Technical innovation and advanced capabilities

As pharmaceutical manufacturing processes continue to evolve, capability for technical innovation is a critical differentiator among CDMOs. Partners who invest in cutting-edge technologies can make the difference in enhancing the efficiency, scalability, and sustainability of your project.

For example in TIDE manufacturing, Bachem’s integration of Multi-Column Solvent Gradient Purification (MCSGP) has transformed the production of peptides and oligonucleotides, enabling higher purity levels, reduced solvent use, and faster production times. Such advancements reflect a commitment to innovation, and future-focused manufacturing.

Seek out partners who have invested in process intensification technologies and automated systems that enhance both efficiency and quality. Evidence of this demonstrates a commitment to innovation alongside the ability to manage commercial-scale manufacturing demands, while maintaining consistent product quality.

7. Sustainability and environmental stewardship

Sustainability is fast becoming a cornerstone of modern pharmaceutical manufacturing. Leading CDMOs actively enforce eco-friendly practices, such as reducing waste, minimizing energy consumption, and promoting green chemistry principles, demonstrating responsibility to both environmental sustainability and their clients’ long-term goals..

Responsible CDMOs will strive to work with ethically sourced materials, and actively pursue sustainability improvements in their manufacturing processes. 

Choosing a partner with ambitious sustainability initiatives not only aligns with sustainability targets and regulations but also demonstrates long-term responsibility and reliability.

Building a strategic partnership

Selecting the right CDMO goes beyond simply ticking boxes—it’s about forging a partnership that supports your long-term goals. By focusing on critical factors such as experience, quality systems, technical innovation, and sustainability, pharmaceutical companies can identify partners who deliver more than just manufacturing capabilities.

A considered approach to choosing a CDMO ensures not only a smoother development process but also a strong foundation for future success in an evolving pharmaceutical landscape.