Continuous evolution and reinvention in biopharma

What have been the most significant developments in the industry for contract manufacturing and development to the pharmaceutical market over the past 21 years?

In our view it has been the advent of biologic drugs and their acceptance as key treatment options in a large number of disease areas such as oncology and immunology. In the past five to 10 years, the focus has shifted to manufacturing and supplying these drugs to the market in an efficient and flexible manner. There is also an increasing need for technological diversity, innovation, automation and creative business models.

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The arrival of biosimilars and establishment of generics is creating pressure on pharmaceutical companies to further enrich their portfolio with new innovative medicines and increasingly focus on more diverse technologies, more targeted medicines and often rare indications. The significant efficacy results achieved by some of these novel medicines, such as CAR-T cell therapies, are also helping to bring them to the forefront in terms of both funding and pipeline activities. Thus, CMOs also need to evolve to produce increasingly diverse and complex drugs in varying capacities.

How has your company evolved to meet these challenges?

Lonza Pharma & Biotech (LPB) has grown in step with the evolution of the biopharmaceuticals industry. This year marks the 21st anniversary of Lonza’s acquisition of Celltech in 1996, which helped us expand into mammalian cell cultures and monoclonal antibodies. Since then, we have both expanded our biologics experience and made strategic investments into additional innovative technologies like cell and gene therapy capabilities. Our recent acquisition of PharmaCell – providing a home in Europe for Lonza’s global cell and gene network – and our collaboration with Octane Biotech around the Cocoon,a fully automated, GMP-ina- box automation device for patient-specific cell therapies, are clear examples of our strategy to solve the most pressing challenges around manufacturing these novel technologies. We are now building the  world’s largest cell and gene therapy facility in Pearland, Texas, which will provide a flexible manufacturing set-up to companies that need capacity for viral vectors, or virally modified cell therapies, and will come online in Q1 of 2018.

What are likely to be the main opportunities and challenges affecting your industry over the next few years?

We believe we will see an increase in tailored, targeted medicines in clinical pipelines and more cell and gene therapy drugs will be approved. The two CAR-T drugs approved in the past few months have opened the regulatory pathway for many other similar therapies. These groundbreaking developments bring high hopes for patients around the world and a new level of manufacturing, with increasingly complex drugs requiring highly flexible manufacturing programmes.

How is your company preparing for these developments?

We can never settle. We work to stay in sync with the market’s needs, varying capacity and changing demand, and as such continue to develop highly flexible manufacturing programmes to deliver those increasingly complex drugs. This entails increasing use of advanced technologies and shifting from labour intensive, manual manufacturing platforms to viable solutions and fully closed and automated systems.

In addition to the cell and gene therapy facility in Pearland, Lonza is also preparing for market developments by creating a technology agnostic and agile manufacturing complex, IBEX, in Switzerland. These will help Lonza to respond quickly to changing customer requirements.

What are your customers’ key requirements from their CMO or CDMO, and how are these changing, if at all?

With small patient-scale batch sizes, centralised production using scale-up processes is no longer applicable and scaleout approaches become the norm. Today, the cost of production still represents a major hurdle on the way to market. Our customers need a true partner who understands these challenges and can build adapted solutions, using new technologies that enable robust and cost-efficient manufacturing, and yield replicable highquality medicines.

How can customers get the most from their CMO or CDMO?

We believe it is critical to have open discussions early on around manufacturing options and development needs. We see this as being more critical for cell and gene therapies, where companies may rush to launch their products without a commercially viable process. At this point, a CMO with significant expertise in process development and optimisation could help avoid significant cost and efficiency issues that can surface later on.

What have been your company’s outstanding achievements of recent years, and what impact has this had on your customers and potentially the industry more generally?

I believe our biggest achievements stem from our ability to continuously evolve and reinvent ourselves as a CDMO, and in the day-to-day activities of our employees who manufacture and deliver these medicines that have the potential to transform patients’ lives. Having supplied 31 small and 20 large molecule commercial medicines to the market and manufactured over 250 molecules for clinical trials in 2016 alone, we are very proud to be the enabler for our customers, delivering the medicines of tomorrow, today.