Covid Vaccine Technology Transfer: 5 reasons, risks, good practices
GMP Compliance Advisor & Auditor
@ PQE Group
Technology Transfer has always been a hot topic and can be even more challenging for complex processes/products like biotechnological ones.
In this Covid-19 pandemic era, different companies are facing technology transfer processes as a mandatory way to boost their covid vaccines production and follow patients’ need, shifting a series of contract manufacturers across the world that must inherit their technology and achieve compliance in a really short timing to meet the production goals.
Transferring a process means taking what was developed in one original company and replicate it into another one: it seems easy but only on the paper! Equipment, utilities, methodologies and documentation can be very different between different companies and this can represent a real challenge once a process needs to be transferred. Moreover, once the transfer is completed successfully it has to be validated, time constraints are also present, even more in the current challenging situation.
5 reasons to perform a technology transfer
- Ensure market access across the world by making the process closer to the patients
- Outsource the process in most strategic areas of the world
- Increase the company business by outsourcing tactical activities
- Ensure a smooth switch from an early development to late development or commercial phase
- Allow temporary or long-term manufacturing relocation, successfully
5 risks in performing a technology transfer without a professional support
- Technological discrepancies between transferring and receiving companies resulting in time consuming and less effective transfer
- Poor technology transfer documentation resulting in possible future regulatory and business issues
- Loss of the opportunity to reach the market on time
- Missing of potentially profitable partnership and/or market access
- Underestimation of the efforts
5 good practices in performing technology transfer
- Ensure the readiness of your process before transferring
- Deeply evaluate the receiving company technical capabilities and quality system
- Rely on a robust technology transfer documentation
- Make sure a strong technology transfer team with cross-functional know-how is in place
- Strictly control timings and budget
Want to know more?
PQE Group staff comprises experienced and skilled experts in multidisciplinary teams, available to support your company on all steps of your Covid Vaccine Technology Transfer: safely transfer your technology to your CMO in full compliance with all local regulations worldwide.
Visit our service page to know more or to contact us, and find the most suitable solution for your company.