Why does it take so long to manufacture new drug products - and can it be done faster?
A new approach has demonstrated that it can.
In fact, this approach has proven effective in dramatically accelerating the pharmaceutical manufacturing process, enabling new drug products to reach the market up to three times faster than conventional approaches – and this means significant benefits for pharma companies, pharma manufacturers, and patients alike.
Historically, the pharmaceutical manufacturing process has been difficult and lengthy. Demanding and evolving regulatory environments and complex cross-functional processes are common reasons given for the typically long set-up times, low overall efficiency of equipment, and difficulties in scaling production quickly.
When it comes to manufacturing new drug products, we find that many of these barriers come pre-built into conventional approaches. But our experience of testing those barriers in a time-critical project has shown that some may be more perceived than real.
Developing a new approach
Faced with the challenge of getting a new drug product to market in what would normally be deemed an impossible timeline, the key manufacturing partner of a leading pharmaceutical company knew that conventional methods would not work. The approach they took proved that many of the perceived barriers could be overcome, and changed perceptions about what is possible to achieve.
Their task – to produce the drug substance for their Pharma partner’s newly-developed Covid-19 vaccine. But to meet their partner’s objectives, they needed to produce the drug substance for billions of doses within 12 months, from a zero base.
This monumental challenge faced further complications, as a new vaccine being produced in new facilities, with new processes and technologies, under a strained supply chain. The manufacturing process also involved many complex interfaces between different functions, all of which had to be tightly coordinated and managed.
To succeed, they had to get new production lines up and running in record time – and then keep them operating at maximum throughput and highest yield and quality levels.
Joining the dots – an integrated approach
Recognizing the need to do things differently, the manufacturing partners engaged Genioo to help them de-risk the end-to-end supply chain, manufacturing, and quality processes, accelerate throughput, and provide practical support to enable the business to succeed.
The result was an integrated approach that combined:
- Deep process and functional analysis to identify key risks and opportunities, and design specific initiatives to unclog bottlenecks
- Expert, hands-on support to enable shop-floor staff to put these initiatives into practice
- An effective PMO process to identify issues along the way and resolve them rapidly.
Unclogging the bottlenecks
As a first step, we worked alongside the manufacturers’ teams to develop Value Stream Maps for each contributing function. We then aggregated these to provide an easy to understand, single, end-to-end view of the entire manufacturing process, from materials planning through to shipping and distribution.
With the process quickly and clearly mapped out, potential bottlenecks and sources of value destruction could be identified. Prioritization of the key risks and recommended remediations led to the devleopment and launch of a program of initiatives to mitigate risks, clear blockages, and maximize throughput.
The Value Stream Mapping exercise provided much needed transparency across the entire process – and more importantly, across the interfaces between different functions. Clearly mapped RACIs and interdependencies gave everyone involved much greater clarity on their roles and accountabilities.
This way of working shifts away from the typical consulting model where external consultants are brought in to develop a plan which is then communicated to internal staff. Instead, it follows a co-creation model. Genioo consultants and staff members came together with their external and internal expertise and insights on how to reach the end goal. The resulting plan had the complete buy in and understanding of all, which deepened alignment, engagement, and commitment from the outset.
Designing a program is one thing, but making it work in a complex, high-pressure environment is another.
To achieve this, Genioo provided hands-on support with a small number of highly experienced consultants with extensive LEAN and functional expertise. They worked alongside managers and operators on the shop floor. Operating as ‘one team’ and combining external and internal expertise, meant problems and issues could be rapidly identified, diagnosed, and resolved and key initiatives could be accelerated.
The extensive practical experience of the consultants meant a smaller number were needed than is typically the case. Internal teams could tap into this knowledge base and broaden their own capabilties and skills as the project progressed.
Identifying and resolving issues – the ‘War Rooms’
A Program Management Office enabled an end-to-end view of the program, and the interconnectivity between all initiatives. But rather than a typical PMO model of reactively tracking and reporting on progress in weekly meetings, the PMO played a highly proactive role.
Given the time frames and the cross-functional nature of the programme, the PMO drove transparency across functions and issues on a daily basis.
A ‘War Rooms’ mechanism offered a structured and easily accessible approach to uncover critical insights through daily tracking of data such as deviations, batch releases, and manufacturing performance. Managers and operators from every function impacted by potential risks or opportunities, gathered in a war room to jointly review the data, discuss solutions, and make decisions.
The War Rooms brought together the right people with the right information at the right time, to solve problems and ensure the project stayed on track.
Changing the paradigm
Together, we set up and readied the new operation in record time. In just three months, we had three large scale kits (production lines) up and running. Another three months on, production ramped up to best-case throughput, with another three large scale production lines in operation.
We achieved this milestone in around a third less time than normally required, despite starting from scratch with a new product, new facilities, and built-to-spec equipment. Our success helped accelerate emergency marketing authorisation for the vaccine, enabling it to reach the people who needed it faster.
More widely, the program enabled the manufacturing partner to deliver on its overall target – to produce the drug substance for billions of vaccine doses in just 12 months – with flow-on benefits to its pharma partner in terms of market share and revenue.
From an industry-wide perspective, the project also demonstrated a template for transforming pharma/bio-pharma manufacturing effectiveness, whether setting up production for new drugs or optimizing existing processes.
The success of the project showed that taking a focused, pragmatic one-team approach can deliver better, faster, lower cost outcomes for pharma manufacturers than more academic conventional approaches.