Around 85% of Pfizer’s small molecule products pass through Sandwich, Kent, on their journey to market. The work of the Kent site’s team helps millions of patients globally. Brian Henry, Vice President, Drug Product Design, Medicinal Sciences provides Megan Thomas, Drug Discovery World with insight into the scientific learnings of Pfizer’s investment in scaling up medical production at the site.
MT: Pfizer has recently invested £10 million in an advanced manufacturing technology that will considerably speed up the development of new breakthrough medicines. How will this technology do that?
BH: The Covid-19 pandemic has highlighted the need to create new vaccines and medicines at pace and scale.
As part of a £10 million investment in our Sandwich facilities in Kent, a new advanced continuous tablet manufacturing process will improve the speed at which small molecule candidate medicines can be produced for Pfizer clinical trials around the world. The increased speed and efficiency are due to removing the need for the traditional batch scale-up process, which is slow and uses lots of the new medicine.
This streamlined and scalable process will help potential medicines progress through clinical trials faster, ultimately bringing life-changing treatments to patients sooner.
MT: Covid-19 has shown us the value of speed when it comes to drug development and delivery. What has prevented this in the past, and what presents challenges for the future when it comes to pace and speed?
BH: I believe the pandemic is a unique situation and we can’t replicate these speed factors for every candidate molecule. However, it is critical that our efforts to accelerate drug development extend beyond Covid-19 and to important new breakthrough medicines for many other therapeutic areas.
There are number of critical factors that we can build on for the future:
The development of a novel vaccine is a complex and lengthy process that generally takes 10 to 15 years. This past year, we worked at an unprecedented speed to develop a vaccine in a responsible way, collaborating closely with regulatory and health authorities around the world – compressing stages that have taken years into months, and those that have taken months into weeks.
We were already researching the mRNA platform for potential flu vaccines with our partner BioNTech; and recruited more than 44,000 trial participants in a short space of time – that volume and speed of recruitment is not realistic in all trials, and especially in some disease areas. Most importantly, it is a unique situation to have all people and parties involved in the process working towards one single, aligned goal.
And finally, focusing our prioritisation process and resource in key areas made a big difference. We have always managed a diverse portfolio of development candidates through prioritisation, but now we have discovered that we can be even more focused and make decisions faster than we ever thought was possible.
Taking this into account, collaboration, communication, and a willingness to embrace innovation are the core three opportunities for the future of drug discovery.
MT: Part of the £10 million investment in the facilities in Sandwich, Kent, is a new Portable Continuous Manufacturing Module. Can you elaborate on the module, what it is, how it works, and how this will improve the speed at which tablets can be produced for Pfizer clinical trials around the world?
BH: The Portable Continuous Manufacturing Module (PCMM) is a new technology which will enable faster and scalable development of tablets for clinical trials and commercial manufacture around the world.
A traditional manufacturing process would typically start by producing batches of a few thousand tablets at a time. But as clinical trials progress onto larger populations, we need more supplies. With the PCMM technology, the module can run for an hour to make a few thousand tablets, many hours for hundreds of thousands, and even longer if millions of tablets are required for ready-for-market volumes.
We would no longer need to run the same manufacturing process many, many times to produce the volume required or develop larger separate batch size processes. We can also rapidly scale up and transfer the knowledge to our commercial manufacturing groups in other worldwide sites in the Pfizer network with the same technology, thereby streamlining the technology commercial transfer process.
MT: When it comes to anticipating potential devastating outbreaks such as what we’ve seen with the Covid-19 pandemic, what does this sort of investment in drug development mean for preparing for the future?
BH: The Covid-19 pandemic has shown us how important it is to rapidly learn about the make- up of a new disease when it emerges and accelerate the application of those learnings to identify existing and new potential medicines that may slow or stop the disease.
One of the most significant challenges we face in developing any new medicine is how to scale up production as we progress through the clinical trial process and on to commercial supplies.
The ability to mass produce a high-quality new medicine and get it to the patients who need it is what turns theory into reality.
Pfizer’s manufacturing strength has been driven through investing in advanced manufacturing technologies and predictive science to accelerate drug development. This enables clinical trials to progress at pace and could drastically speed up the delivery of life- changing treatments to patients around the world.
MT: Pfizer recently joined the Medicines Manufacturing Innovation Centre project. What is the project and what will it help achieve when it comes to getting drugs to market faster?
BH: The Medicines Manufacturing Innovation Centre is a collaboration between an independent deep-tech innovation centre called Centre for Process Innovations (CPI), the University of Strathclyde and founding industry partners GSK and AstraZeneca.
The centre aims to develop a more agile, responsive medicines supply chain through improved manufacturing processes. It will enable new and disruptive technologies to be proven at scale in a good manufacturing process environment. This will allow the rapid adoption of next-generation processes that reduce risk, cut costs and save time, enabling a healthier society and a robust UK economy.
The partnership will also enable the centre to draw upon Pfizer’s extensive manufacture expertise and experience to help address key challenges and maximise efficiency within the medicines supply chain.
MT: You have mentioned that the MMIC project sets “grand challenges” aimed at advancing new technology and patient outcomes in the pharmaceutical industry – what does this mean?
BH: One of the centre’s aims is to advance emergent and disruptive technologies through a series of flagship ‘Grand Challenge’ projects to increase productivity and patient outcomes in the pharmaceutical industry.
The new partnership with Pfizer will focus on Grand Challenge 1, which intends to develop an innovative continuous direct compression (CDC) platform, which will enable oral solid dosage medicines to be formulated more robustly and efficiently.
MT: What will Pfizer bring to the Medicines Manufacturing Innovation Centre?
BH: As a partner in the Medicines Manufacturing Innovation Centre collaboration, Pfizer will provide data on materials, modelling expertise and leading manufacturing knowledge of continuous mixing technology. An important knowledge gap is understanding how the different materials are used to make tablets perform in this new manufacturing process. We hope to be able to build new predictive models and improved digital twins to further accelerate drug development with our new advance PCMM manufacturing technology.
MT: What opportunities and challenges does Pfizer see in the next 10 years in small molecule and oral solid dose medicines?
BH: I believe the main opportunity is to challenge ourselves to be as patient centric as we possibly can be – to harness progress made in areas such as digital technology and product design and apply it to these types of medicines.
Take creative packaging for instance – how can we better utilise QR codes or e-labels as a means of informing patients about their disease and treatment with the aim of improving adherence and compliance?
Or product design – what more can we do to ensure we design medicines with features that work better for the target patient? For example, medicines that are easier to swallow for geriatric patients or an easier to administer formulation for paediatric patients.
This all needs to happen against a backdrop of more and more targeted patient populations. As our knowledge of diseases and genomics improves, patient sub-groups become narrower and more focused. And thus, we end up with more niche products produced at smaller volumes, with the manufacturing flexibility to accommodate that variability.
Volume 22, Issue 3 – Summer 2021