The pharmaceutical contract development and manufacturing market is expected to reach $126 billion by 2024 with the biologics segment expected to grow at the highest rate as there are more than 50 biologic U.S. patents set to expire in the next five years. It is clear that there is ample room to grow, yet not nearly enough discussion about how to do so responsibly.

During periods of growth, contract development and manufacturing organizations (CDMOs) must take certain precautions to ensure that their top priority continues to be delivering the highest quality products to clients. Three important components to preserving a high-quality track record include strictly adhering to a process, making an unyielding commitment to professional development and acquiring the most efficient equipment.

The earlier in the value stream that CDMOs can control the quality of a material, the better off they will be throughout the entire process. Extending their view of that value stream back to the raw materials received from vendors is the smart approach. Whether it is working with clients to identify preferred vendors or vetting new ones through supplier qualification programs, these comprehensive audits are indispensable to product purity. Regardless of increased throughput, these are critical first steps.

Process validation—the next step—is also vital. It is not only how CDMOs develop a repeatable process for delivering reliable products, but also where the relationship between CDMO and sponsor is forged. The collaborative nature of this partnership, combined with the level of communication between the two organizations, considerably influences the quality of the end product. Both sides need to have a firm understanding of what is expected of them and the part they play at each stage of the process, from process design through continued process verification. After all, it is now our reputation that is at stake, and its safekeeping is a shared interest.

As CDMOs grow, through consolidation or expansion, the stakes naturally raise along with heightened scrutiny, and it is pivotal to reassure clients and regulatory agencies that the quality of products will remain consistent. Transparency is the best form of reassurance, and this insight needs to reflect stability. For merging CDMOs, it could mean adopting one set of standard operating procedures over another, and for expanding organizations, it should mean keeping electronic systems as close to the same as possible while conserving a proportional level of investment in employee training programs.

Employees are the lifeblood of any organization, and any investment in them fuels the efficiency of its operations. These investments are especially valuable to CDMOs as they relate to training new, and existing, employees at the senior management level. Leadership will find an indirect correlation between the time they spend training them and variability in their quality systems. With everyone working at the appropriate level, each employee is able to focus their full attention on delivering highly quality products, optimizing workforce productivity.

To transfer this productivity and precision into a sustainable work product, complementary investments in technical competency are necessary. Effective digital capabilities that all CDMOs will want to consider include in-line monitoring of fill weights and real-time particulate monitoring, which allow for early detection and correction of potential issues. By streamlining these activities, CDMOs effectively mitigate error to the extent possible during manufacturing and testing—which can in turn deliver cost-savings to their pharmaceutical partners and give their operators opportunities to perform more complex projects that require human intervention.

On the other hand, if CDMOs operate in the parenteral space, there will likely be additional expenditures in tools that remove human intervention as isolator technology has quickly become a prerequisite. With the growing need to formulate and fill more potent products aseptically, the industry has seen simultaneous growth in the use of this technology, despite its high price tag. The safety and sterility assurances it brings to operators and clients often outweigh its costs. And, given the extent to which isolator technology is customizable, it is uniquely fit for meeting the specific and varied needs of most CDMOs and their partners. There is no denying the return on investment it delivers or the value it adds through concurrent optimization of product integrity.

Prioritizing the quality of products and investing heavily in employees and technology that ensure safety and reliability, is key. Also, training all employees to bring the highest-level of quality to every aspect of their work, is essential.