Strategies for Overcoming Obstacles in Large Molecule Production: Achieving Success
In the rapidly evolving biotech industry, time and cost efficiency have become crucial factors for emerging and small biotechs. Lonza, a leading company in the field, is addressing these challenges by offering integrated programs that streamline the development of large molecules, such as vaccines, hormones, growth factors, cytokines, and antibodies.
Lonza's integrated programs, backed by over 35 years of knowledge and experience in antibody manufacturing, aim to simplify, integrate, and accelerate the development of more complex molecules. With competitive timelines, monoclonal antibodies can go from DNA transfection to IND application in just 11 months, bispecific antibodies in 13 months, and even the most complex proteins in 15 months.
Lonza Biologics Mammalian, a part of the Lonza Group, has developed a range of offerings to manufacture a variety of large molecule types. The company's strategies include using in silico tools to de-risk development upfront, integrating genes into highly active regions using Lonza's GS piggyBac transposon system, and using the industry-standard GS Xceed® expression system for faster development timelines with minimized risk.
The company's approach to large molecule manufacturing is designed to balance risk, time, and costs, creating an optimal path for each molecule's journey to the clinic. Lonza performs a GAP analysis when a customer transfers a commercial or later-phase manufacturing process to best adapt Lonza's services to the customer's process.
Lonza offers bespoke integrated drug substance and drug product programs for any type of large molecule, including bispecific antibodies, Fc-fusion, and other recombinant proteins. Working with Lonza allows customers to create customised CMC strategies and transfer cell lines at any stage of development.
The company also accommodates a range of product transfer situations, including adapting customer's existing processes or developing them to fit Lonza's process. Lonza Biologics Mammalian leverages its long-standing expertise with flexibility to create bespoke manufacturing programs for any molecule type. The company's flexible services allow customers to transfer ongoing programs at any stage of development.
Lonza's tailored programs use a combination of platform processes, advanced toolboxes, and bespoke development based on the characteristics of the molecule. This approach addresses challenges early on, reducing the likelihood of problems arising later, and facilitates tailored analytical characterization and downstream processing.
In the current biotech funding landscape, emerging and small biotechs face significant financial and time-to-market pressures while progressing their molecule to the clinic. Lonza's new suite of offerings focusing on reducing the time to achieve investigational new drug (IND) submission aims to address this challenge, helping these biotechs achieve key milestones and generate critical data before moving to the next fundraising round.
By partnering with Lonza, biotechs can focus on their core competencies while Lonza takes care of the manufacturing process, ensuring high product quality and meeting clinical timelines, all while considering individual customer needs, financial considerations, and key IND milestones.
