BIO
The pharmaceutical development and manufacture of mRNA vaccines and other complex products remains especially challenging in comparison to conventional small molecule drug product development and manufacturing.
To ensure the efficient and seamless tech transfer of these products, manufacturers require the scientific knowledge and technical support of experts. These experts are equipped with the knowledge and capabilities to implement careful forward planning and execution to help avoid any unnecessary disruptions or delays.
But whether tech transfer takes place with a sponsor company, another CMO, or a different site within the same organisation, a variety of challenges must be overcome.
When it comes to facilitating tech transfers, it is crucial to establish robust information transfer protocols between all parties involved. However, complexities arise when these companies do not share the same data transparency level or when a party lacks the necessary manufacturing experience. Overcoming these challenges requires additional support to help identify and implement the required infrastructure and processes at the receiving site.
A range of tips can be followed to ensure best practice across the tech transfer process from sponsor to CMO or from CMO to CMO:
- Transparency: All process documentation, including successful runs and any failures or issues, should be made fully transparent between parties to ensure complete information transfer.
- Technical team observation of the sending unit: Having the technical team from the receiving site observe the processes at the sending unit can help in better knowledge transfer.
- Sending unit team observation of the receiving unit: Conducting engineering runs under the observation of peers from the sending unit can help to capture any yet-to-be-documented process knowledge.
It’s essential that pharma companies pay close attention to the tech transfer capabilities and processes of potential CMO or CDMO partners when making their selection.
The CMO/CDMOs with a clear and robust tech transfer process with a direct line of sight from the start of the programme through to commercial manufacturing are best placed to lead the success of a sponsor company's projects, and should not be overlooked.
With so many factors to consider when considering a tech transfer partnership, sponsors and CMOs/CDMOs must be prepared to overcome the wide range of challenges that may arise.
In a recent Q&A with PharmTech, two experts from our oral solid dosage and biologics business units, share their insights and expert advice on how these partners can work together to facilitate a successful tech transfer.
Click the link to hear more from Uwe Hanenberg, Head of Product Development and Rebecca Powell, Associate Director, Tech Transfer at Arranta (a Recipharm company).