Optimizing CDMO: Challenges And Solutions
Any business that wants to survive needs to be constantly questioning the status quo and staying ahead of its competitors in the market. In addition, the pharmaceutical industry is in massive growth and has a highly fragmented manufacturing sector. Therefore, any CDMO today needs to think about how to compete by optimizing its manufacturing processes and overall development services. As business guru, Tom Peters, wisely said “Excellent firms don’t believe in excellence – only in constant improvement and constant change.”
Revamping manufacturing processes for a Contract Development and Manufacturing Organization can mean several things. A good place to start for any CDMO working with biotechnology and pharmaceutical companies involves the following themes:
- Manage waste and inventory
- Continuous manufacturing process
- Closer collaboration for faster production-readiness
Manage waste and inventory
A CDMO traditionally follows batch processing. Whilst there are good reasons for this, Lean Manufacturing principles can still be applied in some areas and blended in with a batch-production mindset. The overarching question to apply to each manufacturing step is whether it adds value to the end customer. If it doesn’t, then how can it be removed or decreased?
Naturally, the CDMO team needs to find the right balance between, for example, holding too much inventory and having just the right amount to keep the process moving. Although, these days there are software tools that can analyze and streamline any business’s inventory levels.
Continuous manufacturing process
A good example for a CDMO is to implement a continuous moving line where the necessary materials move through an integrated equipment train. This removes the wasted time to pick up what’s needed and it also reduces inventory because you can hold just the right amount that you need. Of course, this involves a different work approach with new tools such as value stream mapping and analyzing Overall Equipment Effectiveness.
Closer collaboration for faster production-readiness
Typically, a CDMO covers the last part of the drug implementation process. This includes API manufacturing, drug formulation and production as well as packaging. Nevertheless, some CDMOs are already looking further upstream and partnering with CRO services, or Contract Research Organization, to get closer to the clinical drug development phase.
This means that the teams can collaborate much earlier in the process to include process requirements in the overall development. Too many CDMOs find themselves with a drug that’s been handed over with tens of process steps that can be reduced to only a handful. Greater collaboration between these companies would make this unlikely and therefore decreases the time taken to launch manufacturing.
CDMO Challenges and Potential Solutions
The biggest challenge with optimizing manufacturing is that it needs a mindset shift from just following an outsourcing approach. Leading any change within a business can be tough but especially so when it’s a transformational change that’s required. Nevertheless, a CDMO that wants to stay commercial and ahead of the curve has no choice, and the following points will need to be considered:
- Lack of technical skills
- Limited investment for new technologies
- Insufficient vertical integration
Lack of technical skills
Any growing industry struggles to find enough skilled talent. This is especially true for a sector undergoing a transformation because teams need to think differently. Recruiting top people will always be a challenge but a CDMO first has to make sure that they’re offering what top people are looking for. This could lead to new internal training programs or updated benefits and well-being offerings to employees.
Another point to note is that people can bring transferable skills from other industries. This also has the added advantage that they will look at things differently. For example, the food industry is also highly regulated and was traditionally batch-focused. Today though, many companies have been transformed by lean techniques and other optimization tools that could be useful for a CDMO.
Limited investment for new technologies
Cash flow is always a challenge, especially for small companies. Nevertheless, implementing Lean techniques doesn’t have to be expensive because it’s often very logical. Another idea is for a CDMO business to look for potential partners with cash reserves and manufacturing know-how.
Insufficient vertical integration
As mentioned, partnerships can be highly valuable for any company. Of course, it comes with its own set of challenges so the setup has to be done carefully. Regardless, a CDMO can expand its range of services through vertical integration, making all parties more competitive.
Key Takeaways for Optimizing a CDMO
Improving and revamping manufacturing processes should always be an ongoing effort. Every CDMO will need to work out its own specific approach but essentially, getting the right mindset for change along with the necessary techniques is the first step. After that, exploring potential partnerships and a more creative recruiting approach can help limit some of the risks. Either way, it’s an ongoing journey of continuous improvement for all.