As biologics grow more complex, so do the tools required to understand, validate, and ensure their quality. From monoclonal antibody cocktails to antibody-drug conjugates (ADCs) and cell therapies, developers are navigating new frontiers in potency, purity, and functional characterization.
Promega’s R&D scientists have been actively contributing to this evolving dialogue through respected industry platforms like BioCompare and BEBPA. Through ongoing collaboration with industry experts, Promega scientists are developing innovative assays and strategies that address the complex challenges of biologics development and quality assurance.
This article highlights key takeaways from five recent publications featuring Promega experts and collaborators, with insights spanning from early research to quality assurance in manufacturing.
1. Rethinking Potency Assays for Contaminant Detection
Jamison Grailer PhD., Sr. Research Scientist, Promega Corporation, BEBPA – Beyond Potency: Leveraging Bioassays for Contaminant Testing
“Detecting these impurities requires robust analytical tools, and bioassays can play a central role in the quality control of these products.” In this article, Jamie explores how bioassays—traditionally used for potency—can serve as a frontline tool for contaminant detection new modalities, such as mRNA therapeutics. By expanding the scope of these assays, QC teams can identify impurities that might not be captured through traditional physicochemical tests.
2. Unlocking Mechanisms Behind ADC Functionality
Julia Gilden PhD., Sr. Research Scientist, Promega Corporation, BEBPA – Unlocking the Multifaceted Mechanisms of Antibody Drug Conjugates
“Next-generation payloads aim to broaden this therapeutic arsenal by incorporating immune modulation, altering protein expression, and directly targeting specific oncogenic mutations.”
The complexity of ADCs where antibody, linker, and payload must work in harmony—requires innovative characterization tools. Julia shares how functional bioassays provide a window into ADC performance, enabling more predictive and precise development.
3. Standardizing Antibody Validation for Reproducibility
Julia Gilden PhD., Sr. Research Scientist, Promega Corporation, BioCompare – Advanced Antibody Validation Strategies to Ensure Scientific Reproducibility
“Our cell-based bioassays have bioluminescent reporters driven by genetic elements that indicate signaling through specific pathways These types of bioassays add a new level of functional information.”
Antibodies are foundational to the biologics field, but inconsistent validation methods compromise quality. This article presents Promega’s commitment to regulatory-aligned functional cell-based assays that not only confirm specificity but also improve scientific reproducibility.
4. Functional Assays for Cell Therapy Characterization
Julia Gilden PhD., Sr. Research Scientist, Promega Corporation, BioCompare – The Promise of Autologous and Allogeneic Cell Therapies
“Allogeneic products come with an economy of scale that accelerates everything. Production and administration are much closer to that of traditional drugs.”
As the field of cell therapy advances, so does the demand for scalable, reproducible assays. This article explores the different challenges presented by autologous and allogeneic cell therapies.
5. Multiplexed Assays for Monoclonal Antibody Cocktails
Jamison Grailer PhD., Sr. Research Scientist, Promega Corporation, BioCompare – Advancing the Development of Monoclonal Antibody Cocktails
“In cases where mAb components act synergistically, bioactivity can be measured in an appropriately designed bioassay demonstrating each component’s contribution in a single readout”
In the era of combination therapies, developers are formulating monoclonal antibody cocktails to enhance efficacy. Jamie discusses the need for functional potency assays that reflect real-world biological complexity.
A Platform for Scientific Progress
These contributions illustrate how Promega’s scientists are shaping the future of biologics characterization—across therapeutic modalities and stages of development. Through collaborative research and open scientific dialogue, we aim to deliver tools that empower pharma and biotech innovators to bring safe, effective therapies to market.
Interested in learning more about our biologics solutions? Explore Promega Biologics Tools
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