Choosing a manufacturing partner in any industry offers incredible opportunities for success while also posing several challenges. This is especially true when biotechnology and pharmaceutical companies start to consider what type of CGT CDMO they want to partner with. Not only do they have the extra pressures of being in a heavily regulated industry but today, they are also under fierce competition. So, how should you choose your CDMO to hit the ground running and truly boost your competitive advantage?
Questions to Consider when Evaluating a CDMO
The best way to start evaluating any Contract Development and Manufacturing Organization is by evaluating several aspects of the CDMO, from services and expertise to flexibility and quality control to industry know-how and regulatory compliance. By evaluating all angles, you’ll be able to keep your goals and requirements in focus when reviewing the CDMO.
We’re helping identify a potential checklist to keep you on track without getting blinded by glowing site visits.
A good place to start is with the following key points that apply to any CDMO:
- Range of services and expertise
- Transparency and company goals
- Manufacturing flexibility and quality control
- Regulatory know-how
Range of services and expertise
With today’s competition in such a fragmented sector, CDMOs are looking to expand their services. They can do this either through vertical integration with drug development services or by expanding into a new dosage form. Any partnering biopharmaceutical business will need to evaluate how the CDMO’s growth plans fit with their strategy and long-term commercial success.
Another critical factor when working with CDMO companies is their view on talent development. Whatever growth strategy a CDMO chooses, they still need a flexible team approach to deliver to the market faster than ever before. This takes a whole new and more agile way of thinking.
Transparency and company goals
Partnerships can work at a superficial level or at a deeper more integrated plane. The more open a CDMO can be with teams providing access to information on either side, the easier it is to collaborate. Of course, this approach has to come from both parties. Simultaneously, leaders on both sides need to align their company and project goals. Overall, the idea is to develop a one-team system.
Manufacturing flexibility and quality control
The market in general is demanding faster turnaround times where there is no room for error. Traditionally, manufacturing processes for the pharmaceutical industry followed a heavily manual batch processing methodology. These days, this will have to be combined with continuous flow and lean principles to develop a true competitive edge. The question now is whether a CDMO can keep up and deliver flexible manufacturing designs.
Quality is always the number one focus. So, it is vital to evaluate a CDMO’s quality risk control process and charts as well as how they monitor overall process control and repeatability.
A quality process that creates a product that doesn’t meet regulatory requirements is missing the point. The overall biotechnology and pharmaceutical industry is highly regulated for a good reason. Moreover, you have to be able to trust your CDMO can meet their requirements without having to micromanage them.
The Challenges of Managing a CDMO
All partnerships need to cover potential risk, even once you’ve met all your requirements from your checklist. Some of the common pitfalls to watch out for are as follows although, there might be more specific ones for your business:
- IP rights and NDAs
- Company culture
- Funds and speed
Intellectual Property (IP) rights and NDAs
When working with a CDMO, you can keep research projects separate but that wouldn’t make for the best collaboration. It’s worth making sure you have a process with a clear definition to cover any IP development and who will own it. Having a Non-Disclosure Agreement is just common sense but they don’t usually cover the intricacies of IP rights.
As Peter Drucker famously said, “culture eats strategy for breakfast”. If the partnership doesn’t fit because of mismatched values and misaligned culture then it doesn’t matter how good your plans are because they will fail.
It’s important to make sure you’re clear about both company’s values and processes around decision making and communications. It can be helpful to look at the details of how people are hired and promoted. This always gives a good idea about what companies value in terms of style and behavior.
Funds and speed
Money is always a concern. Many CEOs and CFOs lose countless nights worrying over the bottom line. So, be realistic about what’s available and what’s possible from each of the company’s funds. Moreover, don’t over-promise something that seems unlikely to be delivered on time.
Key Takeaways for Choosing a CDMO
Great business partnerships work because communication is open and everyone is aligned in their approach and their goals. So, take your time to evaluate your potential CDMO but be willing to also share from your side. After all, equal partnerships work both ways. Involve your teams and get feedback from everyone. Just like any hiring process, it’s about the people and making sure everyone feels comfortable with what’s expected and what’s possible. Get the right culture and your strategy will naturally follow through.
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Last modified: November 2, 2021