Biotechnology and pharmaceutical companies are going through a major shift in approach and mindset. The current pandemic has been a huge wake-up call to the sector that highlighted the limitations of the current supply chain. Now, CDMOs have an incredible opportunity to increase their competitive advantage as pharmaceutical companies look to outsource their manufacturing. This means they’ll be looking for nimble and effective partners. So, how can a CDMO get up to speed, especially with all the pressures of a consolidating market?
Why Flexibility is Key for CDMO Manufacturing
First, why is flexibility so important and what does it mean for a CDMO, a contract development and manufacturing organization? Ultimately, most manufacturing sectors have either been through a turnaround or are about to. Originally led by the car industry with lean manufacturing, flexibility brings many advantages although it does take some effort to implement.
Here are just a few benefits:
- Respond to changes in demand cost-effectively
- Offer a wider range of services
- Fully integrated partnership opportunities
Respond effectively to fluctuating demand
The pandemic is an extreme example that we hope never to see again but some predict that it won’t be the last. After all, the SARS outbreak or the deadly Spanish Flu of 1918 occurred not that long ago. Moreover, increased globalization and rising affluence have seen demand for drugs increase across the world, including emerging markets.
The challenge today is for a CDMO to develop a flexible approach that can cope with fluctuating demand. There’s a big difference between tweaking a production line to respond to fluctuations versus scrambling to keep up. This also impacts cost and time to market for the development and manufacturing organization. That’s why any CDMO company needs to learn how to become more nimble so that their bottom line also benefits.
Offer a wider range of services
Today’s market sector is highly fragmented so any CDMO is at risk of being bought out. If they want to increase their competitive advantage, they need to think about what other services to offer. They can do this both through a partnership or with their change management program.
Either way, it’s a huge benefit to biotechnology and pharmaceutical companies if a CDMO offers support for drug development services as well as packaging services, amongst other offerings. They could also consider providing a wider range of dosage forms from solids to sterile liquids.
Fully integrated partnership opportunities
A flexible CDMO can more easily adapt to create a successful partnership than one stuck in its ways. That’s because the flexible CDMO will have already considered their processes and how these can connect to work with other businesses. By focusing on integration, a CDMO will be more agile with innovative solutions to drive a faster time-to-market. Ultimately, that’s what makes for a successful partnership, along with the right teams but more on that shortly.
How CDMO can Support Flexible Manufacturing
It can be useful to know some of the ways a CDMO can drive flexible manufacturing when considering a partnership. That way, you know what to look for, as described below:
- Modular equipment with high-throughput process flow
- Automation and single-use technology
- Adaptable mindset
Modular equipment with high-throughput process flow
A modular approach allows a CDMO to scale up quickly because the equipment can easily be moved and rearranged as new processes develop. Moreover, it reduces the time to build new facilities meaning that investment costs can sometimes be deferred to post clinical trials. Moreover, high throughput process flow can work in tandem to integrate the processes.
Automation and single-use technology
Flexible manufacturing is a fine balance between automation and hands-on operations when optimizing a process. There’s nothing wrong with single-use equipment because these can often be produced quickly. The trick is to analyze each process for its value-add characteristics and remove any resulting waste, as per lean engineering principles.
There’s no perfect solution but behind every manufacturing improvement is a collaborative and open-minded team. They will know how to adapt and how to be curious to implement the changes required to become more flexible.
This won’t necessarily be easy for a CDMO because skillsets are hard to find in today’s markets. Nevertheless, a CDMO can think about other relevant industries when hiring, such as the food sector, where people have transferable skills and regulatory knowledge. Essentially, the food sector recently went through a similar transformation which could be helpful in a CDMO environment.
Final Thoughts on CDMO Manufacturing Flexibility
Manufacturing expertise can be a significant competitive advantage, especially in a consolidating market. With the extra pressures on supply chain and delivery timings, biotechnology and pharmaceutical companies are also specifically looking for that manufacturing know-how. The more a CDMO can demonstrate this, while being flexible, the more attractive they’ll be as a partner. Then, everything else follows, including funds and customers.