Monoclonal antibody biotherapeutics account for roughly one-fifth of FDA new drug approvals every year, with cancer treatments accounting for the majority of them.
Beside the full-length monoclonal antibodies, researchers are also looking at next-generation antibody products, including antibody drug conjugates (ADCs), antibody fragments, antibody-like proteins, engineered antibodies and others. Moreover, there is also a marked focus on the biosimilar market, which is currently worth roughly $4.3B, and is expected to nearly double by 2026.
That is why, accelerating mAb development to meet market demand requires solutions that optimize development processes, reduce time to market, and select the right partner to spearhead their scale-up activities.
Early-Stage mAb Optimization
Achieving market acceptance for new mAbs can be limited by common challenges in their development and manufacturing processes. Below, we show you which are and how to optimize them.
- Media development and optimization are critical to improving productivity and simplifying workflows by increasing titers and improving protein quality. There are a number of advanced media choices available to optimize processes, including animal origin-free (AOF) and chemically defined (CD) media, available in multiple formats and optimized for different cell lines.
- Innovative feeds, reagents, and additives can help optimize processes, reduce variability, and improve overall workflows, becoming a critical early step for ensuring later success.
- The rapid prototyping services for small scale, can also help in testing the manufacturability and scalability of a formulation prior to cGMP scale-up; modifying formulations by adding or removing a raw material and testing how it will impact a process; testing new and unique raw materials; and converting media to a new format, such as from a liquid to a powder formulation.
- Using analytical platforms that can help developers troubleshoot issues and model optimal processes can maintain consistency during scale-up. This reduces the costs and improves efficiencies.
- The application of multi-omics is opening new doors in biomanufacturing and pharmaceutical process development through the application of proteomics and metabolomics in identifying intracellular pathways. This technology can help to identify how media components are being used by cells and optimize it.
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During this phase, it is important to choose a medium that suits bioprocessing objetives. Some of the media possibilities are liquid and dry powdered medium (DPM).
The liquid and DPM formats both possess pros and cons – while dry format is more economical for shipping and storage due to its longer shelf life, its reconstitution can be labor-intensive and costly. Conversely, the liquid format, which is easy to use and has a reduced risk of cross-contamination, can be expensive to ship and has a comparatively shorter shelf life.
Late-Stage Production of mAbs
While a traditional bioreactor can support most mAb scale-up, bioreactors such us single-use can improved efficiency and performance in mAb manufacturing.
Many of the challenges associated with mAb scaling can be overcome by digitalization-based solutions. Incorporating an integrated solution that records data and maintains end-to-end information fidelity and enables streamlined data transfer through a fully integrated open architecture system is key to this approach.
Finally, it is essential for biopharmaceutical companies to choose a partner with expertise and experience that can apply them holistically across the process. 53Biologics specializes across the therapeutic development, scale-up, and commercialization paradigm. This includes process characterization, advanced analytics, product development, process optimization, tech transfer, project risk mitigation strategies and timeline management.
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Optimizing for mAbs With Support and Experience
A partner with scale-up expertise and experience is a critical part of the commercialization process for any therapeutic.
The scale-up partner will help to successfully bring a biological product to market. Therefore, it is important to evaluate their experience and expertise in process characterization and optimization, product development, technology transfer, biotech business modeling, risk mitigation strategies, timeline management, cGMP sourcing strategies and process simplification.
With an experienced team, 53Biologics can serve as an ideal collaborator throughout the mAb manufacturing process. With our large manufacturing facilities, 53Biologics has the flexibility to minimize delays and maximize the quality of clients’ outcomes.
53Biologics can help biopharma companies greatly reduce costs, mitigate supply risks, and increase productivity for their mAb products.
Would you like to now more? Contact now our mAb manufacturing team!