Monoclonal Antibodies (mAbs)1 derived from hybridoma cell lines are integral to therapeutic applications and are also used to prepare reagent kits. Hybridoma technology is one of the platforms used to produce monoclonal antibodies (mAbs) against a specific antigen.
Hybridoma cell lines differ from the routine Chinese hamster ovary and Human embryonic kidney cell lines. They possess inherent challenges such as hybridoma instability, lower antibody yields, heterogeneity in antibody production, scale-up challenges, downstream processing issues, and regulatory compliance requirements. Addressing these challenges often requires a multidisciplinary approach involving collaboration with scientists from cell biology, process development, manufacturing operations, quality control and regulatory affairs experts.
In response to a specific client’s needs, Syngene Biologics team undertook the challenge of developing a platform technology capable of utilizing hybridoma cell lines to manufacture multiple mAbs.
The development of this unique platform involved a meticulous process flow, ensuring the successful integration of hybridoma cell lines into Ancillary Raw materials (ARM). The three Ancillary Reagents are formulated using five mAbs in defined combinations at specified concentrations. The Syngene Biologics team curated the technology to produce 5 ARMs and it was scaled up at a manufacturing scale using single-use platform technology. These ARMs were then employed in innovative cocktail formulations to create Analytical Reagents (ARs) for the preparation of reagent kits essential in cell and gene therapy. The kit is designed to activate and expand human T cells for immunotherapy in patients.
1 An antibody is a large, Y-shaped protein used by the immune system to identify and neutralize foreign objects such as pathogenic bacteria and viruses
Manufacturing of Ancillary Raw Material (ARMs) and their cocktail formulations to produce Analytical Reagents (ARs)
Stable cell line preparation: Successful preparation of Master Cell Banks (MCB) and Working Cell Banks (WCB) ensured the stability and reliability of the hybridoma cell lines, addressing inherent challenges.
Strategic scale-up at manufacturing scale: The biologics scientists devised a strategic approach to scale up the production process to meet manufacturing demands, overcoming challenges associated with hybridoma cell lines.
Process consistency and uniformity across mAbs: Ensuring consistency and uniformity across the production of monoclonal antibodies (ARMs) to meet client specifications and global regulatory standards.
Robust platform for cocktail formulations at manufacturing scale: The development of a robust platform enabled the effective handling of complex cocktail formulations at the manufacturing scale, ensuring consistency and efficiency.
