If a CDMO Pharmaceutical Company Does Not Answer Yes, Walk Away

The phrase "fail fast" is frequently used in the business sector to indicate a method of obtaining success by knowing what to do and when to do it. It is a mindset that emphasizes rigorous testing and incremental development to evaluate whether a concept is valuable.

As the number of therapeutic drugs in development has more than doubled, the number of CDMOs has also significantly increased. With a wide range of CDMOs to choose from, pharmaceutical companies must prioritize CDMO selection to get the right company to work with for their new drug manufacturing project.

Choosing the right CDMO pharmaceutical company is the most critical factor in successful drug development. This is because the CDMOs are the ones who carry out the projects. They have the greatest influence on your long-term success

To ensure that the CDMO pharmaceutical company can manufacture your drugs reliably and effectively, it is always important to build a strong collaboration to begin this vital relationship. To get your prospective partnership off to a good start, you should ask a few important questions.

1.  Ask Direct Questions

Don't be afraid to ask your potential CDMO direct and probing questions, especially early on. It's essential that you get assurances from possible outsourcing partners that they'll improve your manufacturing process and ensure a smooth scale-up of your active pharmaceutical ingredients (API) in a cost-effective and timely manner.

Also, ask about their teams' previous experiences with manufacturing APIs similar to the proposed task.

2.  Ask About the Timescale

Questions to ask: Can you work to an effective timescale? If there will be a delay in product delivery, how long will it be? How will you handle the delay? Are there measures put in place to prevent these?

Delays of any kind can be aggravating, particularly when outsourcing drug development because so much of the drug strategy is dependent on it, and expenses can quickly accumulate. If the CDMO can't provide accurate or convincing responses, look for another company.

3.  Ask About the Services Rendered

Before you partner with any CDMO pharmaceutical company, be sure about the services they render. The services might not be in line with the development process you need. Ask if they offer solid dose CDMO, liquid manufacturing CDMO, tablets and capsules pressing, affordable packaging, and others.

4.  Ask About the Quality Systems

Are quality systems in place? The CDMO should have appropriate on-site quality assurance and a manual that outlines its quality strategies. They should also be able to demonstrate that they can handle any investigations and resolve issues.

5.  Ask About the Project management and communication style

The capacity to properly communicate throughout the project will significantly impact the drug development.

The CDMO's communication style and culture must match yours to achieve an effective and lucrative working relationship. It would be best to ask the CDMO to describe their communication method. The CDMO may be adjustable in terms of contact frequency and mode (e.g., email, phone, teleconference, on-site visits). If your preferred mode of contact is available, you are good to go.

Whichever CDMO pharmaceutical company you choose, they must be proactive in order to successfully overcome the challenges of drug development.

 
Choosing the Right CDMO Is Crucial to Your Project's Success

Sovereign is your CDMO for liquid manufacturing, solid dose manufacturing, tablet pressing, product development & formulation, fill/finish, packaging, & more! We specialize in the development of innovative formulation methods and specialty pharmaceutical products. Get in touch with us.