SFF
Collaboration between pharma companies, and with contract development and manufacturing organisations (CDMOs), was key to the success of the COVID-19 vaccine roll-out.
Events across the past two years have shown that pharma is more than capable of achieving new levels of speed and efficiency across sterile development and manufacturing processes.
But the success of the COVID-19 vaccine campaign places pressure on pharma companies to deliver not only future vaccines, but also other fill-finish drug products, at a similar speed. To meet these demands, drug developers and their CDMO partners must consider key learnings from the pandemic to prepare themselves for future global-scale rollouts.
Overcoming the challenges
There was a wide range of challenges that pharmaceutical companies needed to contend with to ensure the success of their vaccine roll-outs, including:
- Ensuring capacity
- Upgrading non-sterile filling to enable effective aseptic processing
- Prioritising projects
- Reconciling aseptic integrity and production efficiency
- Controlling the environment to ensure stability
- Ensuring regulatory compliance
Looking to overcome these challenges
Through close collaboration between CDMOs and vaccine developers, the industry has learned a lot about the ways it needs to operate in a post-COVID world.
In order to thrive, these partnerships must be able to offer solutions to these key challenges, including:
- Greater flexibility - The ability to upgrade and extend line capacity quickly and efficiently, as well as the operational agility to quickly address issues and opportunities, are essential to meet the future needs of the market.
- Diverse capabilities - Implementing the diverse processing and manufacturing capabilities, including advanced digital automation, necessary to handle the complex requirements of global primary packaging components.
- Harnessing advances in lyophilisation - Cryogenic logistics and storage costs associated with the majority of vaccines pose a challenge, particularly when transporting to emerging markets where essential cold-chain infrastructure is not yet available. Advances in lyophilisation allow manufacturers to lyophilise vaccine formulations to reduce temperature requirements and ease distribution complexities.
- Closer collaboration - Close collaboration between vaccine developers and CDMOs and harnessing their collective expertise can make it easier to identify potential bottlenecks and identify solutions to keep projects on track, no matter the scale or nature.
With strong partnerships between developers and their chosen CDMOs in place, companies can confidently work together to bring life-changing vaccines to patients at scale in the future.
In our latest piece with BioPharm International, our Head of Commercial, Sterile Fill & Finish Roberto Raffaele Addamo, shares more on his reflections of the COVID-19 pandemic vaccine roll-out. He further examines the challenges faced by pharma companies and their outsourcing partners, and discusses how sterile fill and finish can be optimised for large-volume projects in the future.