As a pharmaceutical start-up, you have a lot of development ahead of you. When you create a new drug and proceed to file an application with the FDA or another federal agency, you’ll need physical infrastructure for your manufacturing needs. This is where Contract Development and Manufacturing Organisations (CDMOs), come in.
This article takes a quick look at CDMOs, and five tell-tale signs that help show you’re in business with the wrong one.
What are CDMOs?
CDMOs are contract development and manufacturing organizations that help conduct process development and the manufacturing of various pharmaceutical products.
The CDMO industry has been very active over the last two decades. Pharma companies of all dimensions, from established drug behemoths to therapeutics start-ups, increasingly value the roles of CDMOs in their drug development strategy. As such, CDMOs constantly compete to expand their service offerings and attract new business, leading to a rapid increase in mergers and acquisitions.
As a pharmaceutical establishment, choosing a CDMO is a critical decision. This is simply because you are creating a long-term business partnership, that will directly influence the success of your present and future products.
Five Signs You’re Working With the Wrong CDMO
Now that we’ve gotten the scope of CDMOs, here are five signs that you could be working with the wrong CDMO partner.
This guide will assist you in determining when your CDMO lacks both the knowledge and the internal quality systems required to get your product into the market quickly, and cost-effectively.
- When You Adapt to Fit Your CDMO Needs— Instead of the other way around
When working with CDMOs either as a start-up or a big pharma company, they should be adapting to your needs or at the very least, they should be mutual adaptability. Many mainstream CDMOs only take clients that must fit into a standardized agreement. This means if you aren’t a major player in the pharma industry, you’ll have to commit to a broad range of services that will waste your resources.
Hence, always search for a partner who doesn’t demand you to conform to too many structures. This entails finding a flexible, service-oriented CDMO that’s willing to adapt to fit your needs. Scorpion Biological Services is an excellent and flexible CDMO example.
- When There’s Less Partnership
It is crucial to remember that your CDMO should be a partner, and not an order-taker. Many drug developing start-ups usually do not identify the early warning signs of a wrong decision.
They could be overpaying for your API, spending too much time to complete your research, or committing to a less profitable process. Start-ups may not notice these risks until it is too late, unless they work with a CDMO partner who takes the time to communicate and challenge them.
- When They Lack a Good Standing With the FDA
You should always work with CDMOs in good standing with the FDA. This means they should have a history of cleared inspections and no significant Form 483 observations on their record. Working with a CDMO that has a tainted record doesn’t indicate a good-quality manufacturing operation, and it also suggests that CDMO lacks valuable regulatory experience.
- Problems With Information Transfer
Instability in the global pharmaceutical supply chain are impeding many drug developers. To succeed, they must deal with overburdened manufacturers, extended border closures, and a slew of other logistical challenges. These challenges also limit opportunities for CDMOs in the pharma industry.
Many drug developers are attempting to navigate these challenges on their own, and the most effective way to do so is through proper information transfer. It should not be difficult for your CDMO to get the right information to the right team at the right time. The best CDMOs invest time in building strong internal partnerships through competent and timely information transfer.
- Submission Documents Aren’t Ready When Due
Regulatory authorities in the United States and worldwide are acting quickly to keep up with new pharmaceutical discoveries and technologies’ breakthroughs. As a result, nothing stays the same.
To succeed in this environment, drug developers must produce submission documentation that gives regulators assurances in both their API and their final product. As a result, drug developers commit this obligation to their CDMO.
However, when you engage with a CDMO whose regulatory submissions team does not collaborate with all other teams, you are guaranteed to receive late or unsatisfactory submissions. This is a strong indicator that you are most likely dealing with the incorrect CDMO.
There is no full-proof plan to navigate the ever-changing drug development industry. However, if you find yourself with the wrong partner, you can’t get anywhere. With this guide, you can easily identify wrong partnerships and get out of them in time to improve your chances of success.