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Pharmaceuticals manufacturing

Contract Pharmaceuticals Manufacturing: How to Select a CMO

The global market for pharmaceuticals continues to grow at a rapid rate. The QuintilesIMS Institute estimates that total spending on medications will reach $1.5 trillion in 2021. The U.S. is expected to account for the largest portion of the growth. Two factors are driving industry expansion. The first is population growth, which is expected to bring the world population to 8.5 billion by 2030. The second is that the world’s population is aging, and pharmaceutical needs tend to increase the older a person gets.

One of the ways that companies that market pharmaceuticals are dealing with this growth is by outsourcing some or all of their production work to contract manufacturing organizations (CMOs). A CMO can provide a wide range of services, including assistance with:

  • Pre-formulation
  • Formulation development
  • Process development
  • Stability assessments
  • Pre-clinical and initial clinical trial material production
  • Later-stage clinical trial material production
  • Scale-up
  • Registration batches
  • Commercial production

Working with one or more CMOs helps pharmaceutical companies quickly scale their operations as needed. It also frees them from certain aspects of project management so they can focus on research and on bringing new medications to market. However, the success of this relationship relies on selecting the right CMO.

Critical Factors in Selecting a CMO to Assist with Pharmaceuticals Manufacturing

When choosing a CMO partner for pharmaceuticals manufacturing, organizations should keep these key considerations in mind:

  • Quality. First and foremost, it is crucial that a CMO has a proven record for high-quality with regulatory bodies like the Food and Drug Administration (FDA). Are they in compliance with all applicable standards? When was their most recent inspection and will they share the results? If a CMO cannot prove that it does excellent work, the evaluation of their potential as a partner should stop there.
  • Project-specific capabilities. A CMO must have the expertise needed to meet an organization’s unique requirements. Project management becomes much more difficult if a CMO has good general experience but no background in the focus area.
  • Location. While it is easy to collaborate on the production of pharmaceuticals digitally from virtually anywhere in the world, if all other factors are equal, there are definite advantages to being able to meet with a CMO in person. This includes the ability of an organization’s quality assurance team to visit the CMO and perform regular inspections.
  • Communication. The manufacture of medication is a complicated process that can be made more so if a CMO is not good about being available for conversations or responding to voice mails or emails. Companies should give high marks to a CMO that has well-defined communication channels.  
  • Capacity. A CMO may be either too big or too small for an organization’s needs. If the CMO is too big, the company may find their projects pushed to the back burner in favor of those of larger organizations. On the other hand, if a CMO is too small, it may not have the capacity to meet a company’s needs.
  • Responsiveness. How quickly does a CMO reply to inquiries? How soon can it get started on a new project? The more responsive the provider is, the better equipped it is to help a pharmaceutical company meet its production objectives.

One More Factor for a Pharmaceuticals CMO: Advanced Production Facilities

In addition to the attributes described above, a contract manufacturing organization should be operating in a facility that is optimized for efficient, effective, and safe operations. That typically means that they have worked with a full service engineering and project management firm to assess all areas of their operations. In doing so, they can ensure that their storage and work spaces, as well as their procedures, are fine-tuned to meet the requirements of their pharmaceutical company clients. CMOs that don’t have the latest equipment or that don’t follow industry best practices probably cannot provide the level of quality that an organization is looking for while meeting delivery deadlines.  

Our full-service engineering and design firm can help both drug companies and the contract manufacturing organizations that help them produce their pharmaceuticals design and implement cutting-edge facilities. We have 30+ years of experience helping our clients meet their engineering, design, project and portfolio management, capital planning, and environmental health & safety needs. Contact APECS, Inc. today to learn more about how we can help with your next project.