Biologics, with their precision targeting, expand treatment options for a multitude of diseases - from cancer to autoimmune disorders. In 2023 alone, 10 antibody therapeutics received their first approvals in either the US or EU according to The Antibody Society. Labs working diligently on these revolutionary treatments face a long and difficult path, but with a few key decisions they can make the journey much smoother.
The Biologics Development Workflow
Biologic drugs are complex molecules derived from living organisms. A prime example is monoclonal antibodies (mAbs), truly the most valuable player (MVP) of immunotherapies. The biologic development process from concept to clinic happens in several stages: molecule development, cell line development, process development and finally, manufacturing.
During molecule development, the focus is on identifying and optimizing the biological molecule—usually a mAb or some antibody derivative. Scientists use various techniques to first identify the molecular target, screen large libraries to select the most promising hits, and then refine these leads to improve therapeutic properties, like affinity, specificity, and efficacy.
Once a therapeutic antibody has been optimized and characterized, the process moves to cell line development. The aim here is to establish a stable and productive cell line that can reliably produce the selected molecule on a large scale. The best cells are banked in preparation for manufacturing.
The Backbone Tech of Biologics Development
What’s the key to success here? A seamless integration of molecule development and cell line development, ensuring scientists have a consistent data flow for making critical decisions.
For instance, during antibody discovery, analytical methods are used to study biophysical characteristics including target binding and functionality, making sure the candidates can effectively target the disease. And further downstream, genetically modified cells are carefully screened and chosen for their productivity and robust growth.
The Challenges of Multi-Vendor Solutions
Traditionally, biologics development laboratories have relied on a patchwork of solutions from multiple providers, leading to a fragmented approach and lots of challenges.
This lack of integration between disparate systems is a drain on efficiency, as data and materials struggle to flow seamlessly from one stage to the next. Moreover, navigating multiple customer service touchpoints and contracts can become a logistical challenge, taking focus away from the science.
There is a growing trend to partner with a single provider due to countless benefits:
-
Integration and Compatibility: Workflow components are designed to work in unison. This facilitates the smooth transfer of data and materials between different stages of development, boosting efficiency and reducing the risk of errors.
-
Simplified Training: Operators master different tools and platforms more quickly, allowing them to confidently run experiments, and leverage multiple technologies together to answer more complex questions.
-
Streamlined Support and Service: Having a single point of contact simplifies the resolution of arising issues and ensures service contracts are clearer and accountability is well-defined.
- Consistent Quality and Performance: Unified workflow solutions enhance consistency in quality and performance, ensuring reliable and high-standard biologics production.
The One-Stop-Shop Advantage of an Expert Partner
Want to bring all the right tech and tools into one smooth, automated workflow? Sartorius integrates technical expertise, trusted instrument platforms, and robust lab essentials into a comprehensive offering that spans the entirety of molecule and cell line development.
By using cutting-edge analytical instruments and validated cell-based assays, researchers can explore molecular interactions and binding kinetics more directly, simplifying their analysis without the need for detection reagents. These vital tools help in understanding complex biological processes in real time, offering key data at every step of the development journey.
Additionally, high-throughput technologies make the screening of clones and media much quicker—key for identifying high-performing cell lines with the right quality traits. This streamlined approach allows scientists to rapidly address critical questions about cell health, growth rates, and protein expression, moving beyond the limits of traditional methods.
Click here to discover more ways to streamline biologics development.