Pharmaceutical companies got a major wake-up call during the pandemic. On top of the need for value-driven drug development, they were pressured to deliver faster than ever before. These days, the rate of scientific innovations and breakthroughs, including cell therapy, is going up which is increasing overall demand globally. The industry is now calling for a major transformation and the CDMO sector has a large potential part to play in it.
Advantages of Partnering with a CDMO
Biotechnology and pharmaceutical companies were forced to collaborate more closely with CDMOs during the pandemic. This highlighted the opportunity for creating true partnerships rather than transactional relationships.
A Contract Development and Manufacturing Organization can offer several benefits when partnering with pharmaceutical companies, as detailed below:
- Greater manufacturing capacity
- Access to one-stop-shop for specific dosage form
- Technology transfer
Greater manufacturing capacity
One of the main reasons that pharmaceutical companies turned to CDMOs during the pandemic is to leverage their manufacturing facilities. Of course, that’s to be expected because CDMO services cover manufacturing. Nevertheless, the CDMOs that stood out were the ones who could integrate effectively and even take on some of the drug development workloads.
Access to one-stop-shop for specific dosage form
A one-stop CDMO offers services along both the supply chain and the value chain. Supply chain services include from the start of the production line and go all the way to the packaging and labelling.
On the other hand, value chain services support from preclinical to commercial distribution. Depending on the CDMO, some might also focus on specific dosage forms so offering exceptional expertise. Overall, this one-stop-shop offering takes huge pressure off the biotechnology and pharmaceutical companies.
A CDMO can also support their partners by conducting trial manufacturing during drug development. This allows the CDMO to develop the manufacturing know-how for that specific drug. At the same time, the pharmaceutical company doesn’t need to build extra prototype facilities.
Managing the Risks of CDMO Partnership
For any partnership to work well, both parties need to understand how their competitive advantage can complement each other. On top of this, they both need to do their due diligence in detail.
The following lists the main areas to consider before outsourcing to a CDMO partner:
- Supply chain integration
- Manufacturing demand planning
- Quality risk management
- Regulatory risk
- Drive transparency and a one-team approach
Supply chain integration
Both parties must be open about their capabilities and vulnerabilities to fluctuations in the supply chain. Geopolitical questions come into play as well as the actual process to integrate and digitalize the supply chains. Not only is real-time visibility important but so is managing the availability of critical materials.
Manufacturing demand planning
Demand-driven planning can reduce inventory. Moreover, data analysis makes it easier to design flexible manufacturing facilities thanks to real-time data. It’s important though that this work is done between both parties in a partnership.
Quality risk management
Quality and safety are both critical parts of manufacturing and a CDMO needs to have the latest processes and technologies. Of course, the partners can learn from each other to keep improving the quality systems. Regardless, the more a CDMO has these qualities in-house, the easier it is for the pharmaceutical company to transfer their product manufacturing needs.
Any business working in the pharmaceutical sector is subject to regulatory compliance. Nevertheless, there’s a difference in how companies can approach this to avoid being overwhelmed.
Knowing when to provide certain information to regulators during clinical trials can speed up the overall process. Some CDMOs even have existing relationships with regulatory agencies to support them with the nuances of the details. Again, this can make a positive impact on the overall timelines.
Drive transparency and a one-team approach
Last but not least, all partnerships revolve around people. Even if the leaders have agreed on how to partner, if the teams on the ground can’t communicate openly, the chances are the partnership will fail. That’s why it can be helpful to involve people from various teams and levels during the due diligence. This will give a sense of how things get done in reality as well as what type of culture and values each company follows. From there, it’s much easier to align the details and work through any issues.
Final Thoughts on Making the Most of a CDMO Relationship
Partnering with a CDMO offers major benefits to biotechnology and pharmaceutical companies. Not only do they provide increased manufacturing capability but they often have in-depth know-how in other services, including knowledge in regulatory requirements.
Moreover, a CDMO can work in tandem with pharmaceutical companies and support clinical trials to speed up the overall approval process. When entering any partnership though, both parties simply need to make sure that they conduct their due diligence properly. This will help ensure a good match that can guarantee future success.