March 26, 2019

How to Select a CDMO Partner for Early Stage Drug Development

Companies in the drug development space have grown from about 1,200 in 2001 to more than 3,600 in 2016, while the number of therapeutic molecules in development has more than doubled – from about 6,000 to in excess of 13,000 – during the same period.1 Thus, to accommodate this level of innovation, it is no surprise many pharma companies have turned to contract development and manufacturing organizations (CDMOs) to help expedite drugs through their pipeline.

For small and emerging companies in early stage drug development, selecting the proper CDMO is a critical step in making the process more efficient and cost-effective, while helping ensure molecules that do enter the drug pipelines achieve marketplace success. Understanding the key traits of a CDMO for your specific needs requires evaluating the following attributes.

Technology/Science – For companies in early stage drug development, selecting a CDMO with the ability to provide a multi-faceted approach is critical. This is particularly important early on because the formulation that will work best with the molecules is an unknown. Therefore, a CDMO with experience in a variety of formulation technologies can better optimize drug development.  Ascendia Pharma has a broad array of technologies to bear, which allows our team to try multiple approaches in parallel, thereby saving valuable time. It also allows us to optimize solid dispersions approaches to more efficiently advance a drug to the next stage.

The use of solid dispersions for enhancing drug solubility has become a popular strategy because of its applicability to a wide range of drug types and dosing requirements. Solid dispersions are useful for increasing the dissolution, absorption, and therapeutic efficacy of drug dosage forms that have poor solubility (a specialty of Ascendia Pharmaceuticals). They work by dispersing the poorly soluble drug within a highly soluble solid hydrophilic matrix.

The process can be used to produce either eutectic products that mix at a non-molecular level, or solid solutions in which the mix occurs at a molecular level. The latter approach is preferred, as the material produced by converting the drug into an amorphous state dissolves more rapidly than the corresponding crystalline drug substance.

Ascendia Pharma has extensive experience in developing and formulating solid dispersions. Spray drying, spray congealing, and melt granulation processes are all familiar to the Ascendia team of scientists.

Facilities – To accommodate a multi-faceted approach, the CDMO must have a state-of-the-art facility with the equipment necessary to offer drug development options. Additionally, the CDMO must operate under current good manufacturing practice (cGMP), which is necessary for compliance with regulatory guidelines. A CDMO needs rigorous procedures in place and must ensure these principles are always followed to meet this standard. Ascendia Pharma has Class 10,000 (ISO 7) and Class 100 (ISO 5) cleanrooms for conducting cGMP manufacture of sterile injectable products, and Class 10,000 (ISO 7) manufacturing suites for production of oral dosage forms. A modern facility is qualified to produce Phase I/II clinical trial materials and has self-contained isolators for use with high potency compounds and/or aseptic processing.

Controlling Cost – Meeting cGMP guidelines while staying within a reasonable budget can be daunting for a CDMO. For emerging innovative companies, however, controlling costs during early stage development is imperative. Again, the leadership team of the CDMO is critical, as its members will have an enormous amount of knowledge and experience to provide proof-of-concept efficiently during the first-in-human stage.

Maintaining Timelines – For smaller pharmaceutical companies and start-ups, developing new drugs and establishing aggressive timelines is critical. A CDMO must present a realistic schedule – and keep to it – despite the pressures and surprises that come with early stage drug development. Selecting a CDMO with an experienced management team, advanced technologies, and a state-of-the-art facility can help establish an efficient and successful timeline.

Experience in Field – Selecting a CDMO with a track record in your specialty will help prevent costly mistakes, missed deadlines, and other issues. For example, Ascendia Pharma has a track record in providing low-cost alternatives in small scale early development for injectables. The expertise of the scientists extends to finding the most effective method of drug delivery for poorly water soluble molecules. Our comprehensive range of capabilities enables pharmaceutical companies to optimize their drug product formulation prior to initiating expensive clinical development.

Leadership & Culture – Deciding on a CDMO is akin to selecting a business partner, so you need to be comfortable and confident in its management team. Ask for an analysis of the products they’ve brought to market to examine if they have experience with formulations similar to yours. Also, review the resumes of the officers. For example, Ascendia Pharmaceuticals has a highly experienced management team that consists of PhD-level scientists and MBAs with 20+ years pharmaceutical experience.

Conclusion

When deciding on a CDMO that best meets your early stage drug development needs, evaluating the science and technologies in which a management team is experienced, as well as its state-of-the-art equipment and facility are strong criteria. Also, consider the camaraderie of the leadership team and how it meshes with your philosophy. Using these elements as guidelines, you can make the most educated decision that will advance your drug through the pipeline.

To learn more and speak to a member of the Ascendia Pharma business development team, simply contact us directly.

References

  1. Informa Healthcare (2016). Blockbuster Trends and Rising Stars of Global R&D: Pharmaprojects Pharma R&D Annual Review 2016.
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