Successful Technology Transfer for Biopharmaceuticals and Biologics
Biopharmaceutical production is increasingly being outsourced, collaborations between public sector and private sector enterprises in the field are increasing and more players are entering the sector.
These are all factors which are likely to mean a greater number of technology transfers need to be facilitated, bringing with them an increased risk of both costly and time-consuming mistakes.
Previous research conducted by Tunnel Consulting of ten major pharmaceutical companies, reported by PharmaTech.com, found many conducted more than ten such transfers each year.
Getting the technology transfer right the first time – no matter the circumstances – is a way to avoid these and ensure the biopharmaceutical reaches the market in the fastest possible time.
Increasing need for technology transfers
The changing landscape of the pharmaceutical market is leading to an increasing number of collaborations between research organisations, governments and the pharmaceutical industry.
Just a few of these were highlighted in a recent article for PharmaTech.com by Chan Harjivan and George Dougherty, including Project Bioshield in the US and the sponsorship of drug development activities within the developing world from The Bill and Melinda Gates Foundation.
However, technology transfers in these circumstances were said to be "unusually challenging" in comparison with traditional commercial markets.
"Interestingly, these drug-development challenges are analogous in many ways to those faced by the biopharmaceutical industry as the era of the blockbuster commercial drug comes to an end."
"Therefore, the innovative approaches being explored in these difficult markets point the way toward potential solutions for sustainable mainstream drug development in the 21st century," the writers explained.
The Tufts Centre for the Study of Drug Development also recently launched the Tufts Institute for Biomedical Partnerships website to facilitate further collaboration between the pharmaceutical industry and research organisations.
Such partnerships hold benefits for both, in that they generate revenues for the university and the pharmaceutical company, while allowing the latter to develop novel drugs using the newest technology.
At the same time, contract manufacturing partnerships relating to biopharmaceuticals are increasing, sometimes across international boundaries, which further emphasises the need for a successful technology transfer.
Executing a successful technology transfer
Despite the seemingly increasing need for technology transfers, this is one area in which many major pharmaceutical companies are still lacking, the research from Tunnel Consulting showed.
Many of these were problems at the top, with senior managers and corporate decision makers not understanding the planning which needs to go into a technology transfer, and the implications this will have on not just the organisation, but also the supply chain, regulatory practices and laboratory functions, PharmaTech.com reported.
"Early and effective coordination" between the sending and receiving sites was not always present and detailed information on how compatible the old systems and new systems are was said to be lacking.
These issues were said to lead to problems with budgeting and scheduling, compliance, longer lead times to market, the supply change and an "excessive" number of rejects, which are barriers the biopharmaceutical industry simple cannot afford to run it.
Speaking to the website, Michiel Ultee,vice president of process sciences at Laureate Pharma, said the key to executing a successful technology transfer is ensuring the issues relating to both the technological and human aspects are met.
Processes which are already well developed will require less work on the part of the contract manufacturing organisation, thus saving time, but whatever the state it is essential to have a clear picture of what is needed.
"Regarding communication or people, we have learned that it is important to set clear objectives and the scope, and for our project managers to work closely with the project manager or project director at the client," he added.
In short, good planning and good communication are needed for a successful technology transfer; much like are required in many other aspects of drug development.