Catalent’s growth from a softgel and small molecule service provider into a partner for drug delivery technology and manufacturing solutions, is the biomanufacturing industry success story.

Julien Meissonnier, Chief Scientific Officer at Catalent discusses the current contract development manufacturing organization (CDMO) space, the role of biotherapeutics and cell & gene therapies, and their evolution.

 

• Could you briefly talk us through Catalent’s general strategy regarding its science and technology platform portfolio especially when it comes to supporting the ever-evolving pharma and biopharma space?

Catalent’s mission is to help people live better, healthier lives. At the core of this is an ecosystem of science and technology that we have built to enable innovation and, ultimately, help our customers to deliver better treatments and patient outcomes.

The past two decades have witnessed the rapid emergence of many innovative therapies and modalities to address disease: firstly, with small-molecule therapeutics, peptides, and traditional vaccines; and then, with the addition of monoclonal antibodies and other recombinant proteins for additional impact.

Today, the industry is broader, and the foundations for drug development have increased in complexity, with emerging modalities such as messenger RNA (mRNA), cell and gene therapies, stem cells, and RNA interference, among others, providing new, and sometimes better ways, to combat illness and disease.

At Catalent, our goal is to build on our 90-year heritage of technology innovation and be the accelerator for our customers and partners, helping them to translate new, emerging pathways for treatments into reality. Through active investment in the technologies of the future, we want to enable broader patient access to treatments based on these new modalities.

Our team of over 3,000 scientists and technicians, across more than 50 global sites, are tasked with resolving the most complex CMC challenges in our industry. They are effectively our innovation engine. To enable our scientists to stay at the forefront of their fields of expertise, we established an internal Scientific Resource Centre to promote dynamic learning and collaboration across that team. This enables the organisation to share experiences, collaborate, and learn from each other, but most importantly, allows us to leverage what I think is the most compelling technological and scientific assets in the industry.

• Catalent’s venture into Advanced Therapy Medicinal Products (ATMPs), such as cell and gene therapies, really taps into an overarching mission to offer true end-to-end services for clients. Would you say this space has become especially attractive due to possibilities of producing cures and not just treatments?

True CDMOs such as Catalent have radically transformed over the last three decades from being transactional outsourcers providing contract supply, to becoming strategic partners across the development pipeline from pre-clinical to commercialisation. This is especially true for ATMPs, where cutting-edge science is powering the next generation of medicine, and innovators are looking for partners to accelerate the discoveries towards clinical phases, with manufacturing and process development expertise.

Catalent is supporting innovators of all kinds, including those working with emerging modalities such as cell and gene therapies, stem cells, protein degraders, and mRNA, by providing key scientific and technological building blocks to promote the most appropriate development, delivery, and manufacturing technologies at the correct time in the product innovation process. These building blocks include, for example, plasmid DNA, induced pluripotent stem cell (iPSC) banks, and novel 3-dimensional cell therapy expansion platforms.

• With the relatively recent acquisitions made with Paragon Bioservices and MaSTherCell, what was the thinking behind these two purchases and exactly how did they complement Catalent’s existing services? Were you looking for a long time to get into this space or were those deals quite opportunistic when the opportunity arose?

Catalent continuously looks for strategic opportunities to supplement its product portfolio through acquisitions, especially in high growth sectors. To do this, we undertake assessments of emerging modalities and monitor the “pulse” of innovation within the industry. When it is appropriate, and there is clinical evidence to suggest technologies have reached the critical tipping-point of potentially becoming transformative therapies, we consider investing or acquiring the appropriate scientific and/or technological platforms that can serve innovators and accelerate their access to scale. Such disciplined strategic assessment means that we avoid investing too early in modalities that are yet to demonstrate their ability to transform the way diseases are treated, or even cured, enabling us to maximise the utilisation of our new science and technology assets and bring maximum benefit to patients.

It was this exact process that led us to enter the gene therapy and cell therapy markets when we did, by acquiring Paragon Bioservices and MaSTherCell, respectively. These acquisitions were the culmination of over five years of monitoring those markets, the technologies, and companies within it.

• Do you think it’s more important for a CDMO to be able to offer science and technology platform technologies and such in the cell and gene space rather than the biologics or even the small molecule space? Why is that?

Science and technology platforms are—and remain—at the core of every modality that Catalent develops, manufactures, and delivers. In cell and gene therapies and emerging treatments, the level of manufacturing technological maturity is much lower than for small molecules and protein-based therapeutics, such as monoclonal antibodies, partly because these new therapies have, over recent years, been propelled to the clinics and to commercialisation at a much faster pace than the now established modalities were. Looking simply at the evolution of expression technologies for monoclonal antibodies since the late 1990s, expression levels have progressively increased from the hundreds of milligrams per litre, to well in excess of ten grammes per litre, while process intensification has continued to climb a very steep curve to support that pipeline’s development, and reduced the costs of manufacture, expand its applicability, or gain scale. We believe the same technological advancements will be seen in cell and gene therapies.

Catalent now has the tools to lead the CDMO industry in bringing the next generation of development, drug delivery, and manufacturing technology innovations to scale, so that more patients can benefit from these new therapies.

We are confident that our latest technology innovation efforts in areas including viral vector manufacture, multi-specific expression, and protein degrader development have the potential to transform the landscape of such therapies.

• Over the past 10-15 years, the sort of relationships Catalent had with clients for products such as softgel and certain biologics, was very much a simple vendor supplier relationship. With the advent of cell and gene therapies, which are very innovative and relatively unknown, would you say the relationships with your clients have evolved to become strategic or far more entwined?

Our relationship with customers across all modalities has evolved, especially as we are a strategic partner for many programs, or, in the case of emerging biopharma companies, Catalent provides the comprehensive development services to help them gain funding, progress programmes through early-phase trials, and then be a reliable supply partner that can support the initial launch and global commercialisation of a drug product.

At the same time, we have become more forward-thinking about the way we partner with innovators. Our dedicated scientific advisory team help customers design and tailor their strategic CMC and manufacturing strategy for each therapy’s specific needs. We operate an open model, whereby our team of advisors bring complementary expertise, as well as evaluation and analysis of pre-existing datasets, to maximise an innovator’s chance of success and avoid pitfalls. To date, we have helped reorientate the development of around half of the candidates we have worked on, for example, by selecting a different candidate, or an alternative technology that has maximised the chance of success.

Through its sustained investment in new technology platforms, Catalent provides partners with the technological tools to help them accelerate innovation towards future development and commercialisation. I believe this approach makes Catalent a good partner today, and an even better partner for the future.

• With the pace at which cell and gene therapies are evolving, could you comment on the kinds of innovative technologies within this space that you think could play a key role in the next five years or so?

New biological hypotheses explored with cellular therapies, including autologous, allogeneic, or iPSC-derived therapies, have the potential to become the means of earlier and more effective treatment options for certain diseases. Therefore, transformative, scalable, closed-processing cell therapy manufacturing platforms will be necessary to enable the vision of wider accessibility and improved health. Our investment in novel culture platforms, whether iPSC-derived or not, will be an important move for the industry.

Speed and scale will remain paramount. Technologies that offer more speed could, for example, provide faster access to DNA, and more scalable manufacturing platforms can potentially bring the process used for adeno-associated virus (AAV) manufacturing closer to the efficiencies expected of monoclonal antibody production today. Also, viral vector gene therapies are immunogenic, which limits innovators to a single bolus administration with limited possibility to re-administer. We believe that technology platforms potentially capable of reducing immunogenicity of an AAV, still yet in preclinical stages, will enable re-dosing, better transgene expression, and be transformative over the coming years.

These emerging therapies also raise new bioanalytical challenges to ensure consistent product safety and efficacy, and have created a resounding call for additional capacity. Consequently, scientific advancements into multi-omics platforms, and establishing data from single cells and nuclei, will be each transformative in that space. Catalent is investing at scale both in novel platforms and in the development of a highly skilled scientific community to stay ahead in every aspect of our work for the benefit of our customers and their patients.

And we should not overlook the role that small-molecule drugs still have within pharmaceutical innovation, because the number of exciting scientific advancements in that field continues to accelerate, including in areas such as protein degradation. In response to this growth, Catalent has developed a novel, targeted protein degrader developability platform that we believe will improve the likelihood of successful development of those innovations by making them suitable for oral delivery.