“Lonza is looking at how we can industrialize the cell and gene therapy manufacturing processes and platforms. One of the key issues is a shortage in supply of viral vectors, and our new facility in Houston is a direct response to this.”
Lonza completed its largest-ever acquisition in 2017. Could you provide insight into how Capsugel has been integrated into the company?
Historically, Lonza has been primarily API focused in our service offering. In 2016, the company made the decision to expand its services and move further down the value chain to offer drug product services for small molecules and biologics to our clients as well. We determined that an acquisition for solid dosage forms was the most strategic path and subsequently bought Capsugel. Over the course of 2017 and 2018, Capsugel was integrated into Lonza Pharma & Biotech – the traditional CDMO side of the company – as well as our Consumer Health & Nutrition business. It was a perfect acquisition for us, and we are pleased with the success of our integration efforts. We now have integrated service offerings covering the full value chain, including development and manufacturing of drug substance and drug product solid dosage forms, and can help customers with specific pharmaceutical and delivery challenges of their small molecules, such as bioavailability, taste masking or modified release.
With regards to Lonza’s drug product capabilities in the biologics space, how have you driven growth?
For the biotherapeutics area and parenterals, we have focused on organic growth through initially securing the right capabilities and talents, basing our new offerings on strong scientific, regulatory and industrial experience. As parenteral drug products were something new for Lonza, we aimed for a step-wise approach and started by implementing drug product development services in 2016 in a new facility in Basel, Switzerland. Since then, we have successfully expanded our parenteral drug product capabilities and capacity and grown our team, and the next step for us is to offer in-house cGMP fill and finish.
Through our IbexTM Solutions we will be providing customers with biopharmaceutical product support throughout the lifecycle from preclinical to commercialization from cell line construction to drug product manufacturing all in one location, including a sterile fill and finish facility that will come online in 2021. In the meantime, we are pursuing bridging strategies for drug product manufacturing, including third party suppliers and potential acquisitions in this area to further strengthen our offering.
Lonza Pharma & Biotech’s 2018 organic sales growth was at 13.9%. Where are you seeing the greatest increase in demand for your services?
Lonza’s growth in 2018 came from both sides of our business – small and large molecules. We are seeing increased demand within the pre-clinical and clinical areas in particular, with a healthy pipeline of new molecules in early phases. This gives us a good view on the future market and helps to seed the commercial offering. We are still seeing a very strong demand from our large pharma customers and increasingly from small biotech that often have quite specific needs from a CDMO – this is an area of growth for Lonza.
As Lonza moves further into the biologics space, how are you able to help biotechs de-risk their molecules?
Lonza’s role is to help our customers de-risk their molecule and development pathway towards commercialization and provide the optimal environment for success. We have a portfolio of late discovery services that we offer at our Cambridge, UK facilities, called Applied Protein Services. We will look at the structure of customers’ molecules and help them choose which lead candidate to take forward with the best chance of success. We rely on bioinformatics as well as in vitro analysis to weed out potential issues with developability, stability risks, manufacturability and immunogenicity.
Molecules are also becoming much more complex. We can de-risk these molecules by providing technologies including expression systems that enable our clients to bring difficult-to-express proteins to the clinic. We are also focused on how we can help them to put in place robust and scalable manufacturing processes, to support them as they move through the clinic to commercialization.
Given that the CDMO space is becoming ever more consolidated, what is Lonza’s value proposition to the industry?
Lonza has a focus on innovation, in both technology and business models. As more complex molecules move towards the clinic, we are looking to offer a broader toolbox of synthetic biology solutions for development and manufacturing. With our business models, our attention is on getting our customers to their key milestones – IND and BLA – faster with reduced risk through our Ibex Design and Ibex Develop solutions. The regulatory world is changing dramatically, and we have a significant number of customers on breakthrough and fast-tracked regulatory pathways. We help our customers prepare for very fast transitions from early clinical phases through to launch.
Lonza opened the world’s largest dedicated cell and gene therapy manufacturing facility in Houston, TX, in 2018. What is the significance of this investment?
Lonza is looking at how we can industrialize the cell and gene therapy manufacturing processes and platforms. One of the key issues is a shortage in supply of viral vectors, and our new facility in Houston is a direct response to this. In general, we are developing technology and processes that enable our customers to deliver economically viable therapies for patients. For example, we are working to create greater efficiencies in areas like scaling up allogeneic cell therapies and viral vector manufacturing. However, for highly personalized medicines such as autologous cell therapies, which are specific to individual patients, the question is not how to scale up, but how to increase automation in manufacturing for individual patients. We hope to continue helping advance and standardize these emerging therapeutic areas and the treatments – or cures – they may offer thousands of people around the world suffering from debilitating genetic disorders or other diseases.
How would you like Lonza to be perceived by the industry moving forward?
Lonza has 120 years of experience in providing services to customers, and we aim to be a second brain for them as well as an extra pair of hands. We can help them strategize the best way to get their molecule to market as efficiently and with the least risk possible. Our goal is to enable our customers to meet their greatest challenges in delivering effective and safe treatments for patients.