Outsourcing
In light of the pandemic, tech transfer has been emphasised as key in streamlining production processes at scale.
technical transfer process, which is based both on thorough technical processes and, to some extent, an assessment of the cultural fit with its CDMO. “We set up the tech transfer by creating an overriding document and then one for each unit component of the manufacturing, such as upstream, downstream, conjugation, and fill and finish,” Mulkerrin explains. “Then we have a meeting, typically a day or perhaps two, after two on-site at the manufacturer.”
“We set up the tech transfer by creating an overriding document and then one for each unit component of the manufacturing, such as upstream, downstream, conjugation, and fill and finish.”
“There is a component that is cultural, but clearly it is mostly technical,” he adds. “Our internal alignment is within the manufacturing group for the manufacturing, as well as with the regulatory and quality organisations. The same is true for the quality control group. We rely on the experts to help each other and as long as there is respect for the organisation then it will run smoothly.”
Essential steps to streamline tech transfer
While the pandemic has highlighted the need for speed in all stages of vaccine production and manufacturing, and it has cast a light on the areas where delays arise, it must be remembered that the window for tech transfer in the vaccine development process was already narrowing. Ten years ago, it might have been normal for a full tech transfer to take between five and ten years. In that context, 30 months does not seem long at all. Nevertheless, that trend of acceleration must continue, and the pandemic has shown that it can. Tech transfers involve many challenges – not least the need to account for the safety, quality, and
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efficacy requirements of life-saving products that can, at the same time, be potentially toxic. That places a great burden on the production process, as does the complexity of the manufacturing process, which requires a large team of highly skilled experts striving for the highest quality standards. So, what kind of steps can be taken to streamline the tech transfer process and shorten timelines for production? McKinsey’s researchers have looked closely at this problem and identified key parameters that, though familiar to ADC and others, are now more clearly codified. Many of the steps relate to early planning and instituting a process for rapid decision making. From the start, the pharmaceutical company should define a clear end-to-end strategy, detailing even the contract manufacturing phase. Standardised documentation for feasibility evaluation, as well as early clarification of filing requirements and country-specific issues are also high on McKinsey’s list of priorities. Other factors, however, stem from a pharmaceutical company’s relationship with its CDMO. These include the need to work in partnership to identify risks in the transfer process and to instil a mindset of continuous improvement. Taking every step will not eliminate every hurdle, but it will go a long way to making a tech transfer both swift and successful.
“For early programmes, we can encounter problems in the development of a process, but for our later programmes we expect the surprises to come much less often,” says Mulkerrin. “In a good relationship we expect the problems to be worked on as a collaboration, with both sides contributing to the solution. It is with new programmes that the industry usually encounters problems.” “Our evaluation of a CDMO begins with an assessment with a team travelling to the site,” he adds. “Then we have an RFP [request for proposal] they answer, and the depth and clarity of the response is part of the evaluation. Then the quality assurance organisation will audit the company. Each of these steps in our evaluation permits us to understand the organisation we are evaluating. We value the technical capability and their quality temperament the most.”
The pandemic has emphasised the need for tech transfers to be seen as an opportunity for streamlining the production process at scale, rather than as a bottleneck. This applies directly to Covid- 19 vaccines and therapeutics, but a push for more standardised methods for sharing information and manufacturing know-how could have far-reaching implications across the industry. Technical transfer, with the right strategic planning early on and a clear process for assessing the CDMO relationship, can be an opportunity to make products and processes better, rather than just another hurdle to clear. ●
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
eamesBot/
www.shutterstock.com
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