"Our fixed-price, fastest DNA-to-IND program is packaged in a standardized platform to allow clients to bring a new antibody molecule to IND filing in a rapid amount of time."
What is driving the mammalian cell culture space in 2022, and which of the company’s services are most in demand?
Lonza’s strength and expertise over the past 35 years, from the perspective of biologics development and drug substance manufacturing, has been based on the company’s capabilities around cell culture development in clinical and commercial manufacturing. We continue to strengthen our offerings by further developing and expanding our host cell lines, improving our manufacturing platform, and investing in our tech transfer capabilities. Much of our R&D efforts are focused on increasing titers and improving the stability of constructed cell lines. This not only ensures better commercial viability of molecules but also helps Lonza clients to understand flexibility and improvements to cost of goods they may benefit from long term.
Can you highlight key initiatives Lonza has been involved in over the past year?
An initiative that we embarked upon before the pandemic is our Ibex Design offering. Ibex Design leverages Lonza’s technologies, tech transfer capabilities, and automated bioprocesses to meet the huge surge in interest in speed to clinic. Our fixed-price, fastest DNA-to-IND program is packaged in a standardized platform to allow clients to bring a new antibody molecule to IND filing in a rapid amount of time, guaranteeing to break through three major milestones: five months from DNA to TOX drug substance; 11 months from DNA to IND/IMPD; and minimum 1.5 kg GMP drug substance for phase 1 clinical trials.
This initiative leverages our versatile cell line engineering technology called GS piggyBac. This platform allows us to deliver higher titers and a more robust and reliable output of complex proteins and monoclonal antibodies. In turn, our clients will see improved cost of goods in the long term as their molecules proceed through the clinic.
Finally, we have added capabilities and capacity at four of our sites, including our facilities in Switzerland, China, UK, and Singapore, to facilitate speed to clinic and support the development of increasingly complex novel biotherapeutics.
How does Lonza work to simplify the complex development and manufacturing process, particularly when it comes to conjugates?
We see in the market that many clients are investing in the development of bioconjugates. As such, the market seeks faster, more reliable and simplified supply chains to support the development and commercialization of new bioconjugate molecules. Lonza has the largest antibody-drug conjugate facility in the world, proximal to our Mammalian drug substance manufacturing Ibex Design Facility based in Visp, Switzerland. At the same site, we have also invested in a drug product vial filling facility. Together, this offers a one-stop-shop experience to our clients, which simplifies the supply chain, de-risks technical exchange of materials and data, and facilitates program management.
How does Lonza leverage innovative technologies in the drug development process to maximize high-quality productivity and reproducibility?
Lonza has listened closely to the needs of our customers to better understand what unique challenges they have as they move from the clinic to commercialization. We worked to deliver on several innovative technologies. With respect to reproducibility, Lonza has utilized digital-based training to standardize our manufacturing approach across our global network. We have also invested in electronic batch records in several of our new facilities to accelerate and standardize batch record preparation and batch release time while also working to reduce human error risks.
Lonza continues to invest in perfusion-based and protein intensification manufacturing technologies. Our initiative is to provide n -1 perfusion capabilities in clinical and commercial manufacturing to achieve higher protein titers and ultimately reduce the cost of goods for our clients.
Can you elaborate on Mammalian’s performance over the past year and the company’s growth strategy moving forward?
We saw extremely strong growth, which was enabled by our significant investments into our Lonza Mammalian network by expanding capacity and strengthening manufacturing and development capabilities. Within Mammalian, we have approximately 12 assets around the world, and we have invested into 60% of them over the past two years. This has allowed us to meet the demands that came to us during the pandemic. In biotech and pharma, in general, there is an increase in outsourcing, and we have the capabilities and capacity to service these market demands.
Our long-term strategy is to continue to build on our capacity and capabilities to further support our clients with their BLA and IND filings of new biologic molecules. We have experienced steep growth over the past year, and our goal is to continue to deliver on our commitments from both a quality and operations perspective.