by by Richard Dennett, Director, Voisin Consulting Life Sciences
What is Technology Transfer?
Technology transfer happens at each pivotal stage of the product/process development lifecycle of a biopharmaceutical product – this can be, for example, from development into cGMP manufacture, for the purpose of licensing, and as a function of outsourcing contract manufacture. At each of these stages it is essential to demonstrate that the process remains robust and that the product (which can be influenced by the process) pre- and post-transfer is comparable. To do this it is necessary to transfer the methods, materials, equipment, training and knowhow required to realize the transfer. Whilst this may look easy when written in a couple of lines of a blog, in reality, and for the manufacture of biopharmaceuticals, this can be very complex and any fault in a single aspect of technology transfer can seriously impact the whole program.
How do you know that you’ve achieved technology transfer?
Key to this is meeting pre-determined acceptance criteria, such as:
- Qualification that the analytical methods can be reproduced
- Demonstration that the process can be operated in accordance with the manufacturing instruction
- Comparability of the product – it is essential that the active product meets equivalent pre-and post-transfer specification – this can involve testing of general specifications through to in depth characterization of higher order physiochemical properties to highlight product integrity or product associated impurities
So what tips have you got for making a successful technology transfer?
- ‘Buy-in’ – development, manufacturing and quality should be a focus of the technology transfer team and this should be replicated within the giving and receiving party.
- Planning – plan ahead. An emerging biotech may think that technology transfer will take a couple of weeks: a seasoned biotech knows that successful transfer can take up to several months.
- Strong project management and communication is essential
What advice would you give anyone currently embarking on technology transfer?
Build up a solid understanding before you start and, if possible, gain access to someone who’s had experience of doing it before.
What are the trip hazards?
- Not following the plan of what needs to be transferred, how this will be done and assignment the correct acceptance criteria.
- Lack of proactive project management
- Rushing into things
What is your experience with technology transfer?
During my career I’ve worked at the development/cGMP interface of projects, as a technology transfer manager in a contract manufacturing organization and now within regulatory CMC – so I have had great opportunity to see technology transfer from all angles.
Tech transfer from a regulatory point of view is key for supporting comparability within the dossier submission and technology transfer protocols and reports may be scrutinized as part of the pre-approval inspections – therefore it’s serious stuff.
What are your key take home messages?
- Treat technology transfer seriously
- Take time
- Gain buy in
- Plan correctly
- Make sure you know what you are transferring and how you will achieve acceptance of the transfer.
- If it isn’t written down it never happened – quality documentation – technology transfer protocols and reports are essential.
We heard that you’re a fan of paper aeroplanes?
Yes, look out for these at BioProcess International. I’m actually an amateur pilot and recently had a crash landing in the last plane I flew – a 1930s designed ‘flying flea’ – technology transfer of the understanding of the flight characteristics was to blame – paper aeroplanes are much safer!
2014 – Why is technology transfer important today and what added value does it hold?
Technology transfer is essential. Correct technology transfer can mean the difference between a successful or failed project. Done correctly, technology transfer can build in product/process robustness and positively expedite your development program therefore reducing costs and time to market.