Selecting the optimal cell line is a critical early decision in the development of any biologic drug. It can impact everything from expression yields and product quality to regulatory timelines and commercial strategy. One key consideration for many developers is whether to use a licensed or unlicensed cell line, and the right answer depends on the specific goals, timeline, and product profile.
At 53Biologics, we do not offer proprietary strains or cell lines. Instead, we prioritize flexibility. We tailor our services to meet each client’s needs by offering microbial production using different hosts, including bacteria, yeasts, and even fungi. For mammalian cell lines, we work with trusted partners to evaluate and implement the most suitable option for your project.
Licensed Cell Lines: Speed and Proven Performance
Licensed cell lines can be a strong choice when speed is essential. These platforms are typically well-characterized, with documented regulatory history and robust performance in GMP manufacturing. This can de-risk development and accelerate timelines, particularly for clients aiming to enter the clinic quickly or seeking a smoother regulatory path.
However, these lines often come with licensing fees and usage restrictions, which may limit flexibility in scale-up or commercial manufacturing.
Unlicensed or Custom Cell Lines: Control and Long-Term Value
Opting for an unlicensed or proprietary-free strain gives developers more control over the production system, without ongoing licensing costs. This route can be particularly valuable for companies planning long-term commercialization. It is also beneficial when a highly customized production strategy is needed to achieve optimal yields or product attributes.
Developing a new strain may take more time and initial investment, but it offers greater freedom in the long run.
A Flexible Approach at 53Biologics
Since we do not promote in-house cell lines, we are positioned to offer unbiased guidance. Whether you are considering E. coli, Pichia pastoris, filamentous fungi, or a mammalian system, we will help you evaluate the best fit based on your molecule’s complexity, target timelines, and strategic goals.
If you need mammalian lines, we collaborate closely with experienced cell line developers. They can integrate your preferred strain, or help you select and characterize a new one, into a tailored development and manufacturing plan.
Need help deciding on the right production system?
Visit our recent post or contact our team at 53Biologics to explore how a customized, license-free approach can bring flexibility and value to your biologic program.
About 53Biologics:
53Biologics is a Spanish CDMO specialized in decoding biologics production, from DNA to proteins. The company provide services from preclinical development to GMP manufacturing, supporting their clients in getting their biological products to market as quickly as possible.
For more information or to speak with one of our experts, fill out our contact form or email us at in**@53*********.com.
