CPHI Barcelona: Outsourcing in Manufacturing Operations

During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most. 

Contract Arrangements in Pharma Manufacturing 

The core question of Fraschetti’s presentation focused on how the responsibilities of contract organisations and manufacturing linked together. “The moment you sign a contract with a CMO, you’re not just signing a contract for the service itself – you’re signing for a relationship,” Fraschetti stated. Working effectively together is the key to optimising such relationships. 

Fraschetti used an analogy of a parent (the manufacturer) ensuring the child (drug product) arrives home (the patient). Care must be taken in not only getting the child home, but also how. Qualities such as safety and efficiency. Quality Agreements and Financial obligations provide a guiding framework to relationships between manufacturers and CMOs, but this will not be what is impacting day-to-day observations and communications. 

Effective Issue Resolution: oversight and clear communication 

Fraschetti gave a case study overview of how to manage and optimise CDMO relationships with success during a product’s commercial launch. “In March of [2023], we were executing a transfer for the most promising biologics product within our clinical pipeline,” Fraschetti explained. “During the first batch an active ingredient, we observed several issues that were not observed during development. We had two major issues – we couldn’t fill the product with the assembly that had been selected but it just did not perform because of high viscosity. The other was a tendency of the product to clog.” 

With 7 months to go until PPQ, the team needed to rapidly search for solutions. “Achieving the speed and agility in solving these issues had several components… Oversight models and clear communication channels were very important. It’s important to know who to reach out to when you need something from both sides… the other thing is really establishing a relationship and treating people as partners. You can’t achieve speed when relying on the CDMO to do most of the work and purchase the assemblies when you don’t work with them to get a product to the finish line… this is not something you do by promising a certain number of buyers during the commercial phase – you need to get [the CDMO] involved... you do that by establishing a partnership and clear points of contacts, with more opportunities to work with each other and even have informal chats to navigate through issues that occur.” 

Ultimately, successful contract partnerships are achieved when a positive working environment is established for all parties involved. “When working in an outsourcing relationship, there is an expectation that both parties have oversight of the manufacturing process. Of course, there will be agreements to provide framework for that oversight but on a day-to-day basis it is important to effectively leverage relationships. In order to do that, it is very important to have clear points of contacts and lean paths of communication… establishing relationships where both parties feel engaged, where it really feels like a partnership than an agreement, the most important person that will benefit in the end will be the patient.” 

To watch the full presentation from CPHI Barcelona, click here.