PepTalk 2023: An Overview

Last month, scientists working in drug discovery and biologics development were treated to an informative and insightful PepTalk 2023 conference in San Diego, CA from January 16-20. More than 850 participants from top global pharma, biotech, academic, and governmental institutions convened to learn about the latest scientific advancements in cutting-edge biologic therapies.

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Specific areas of focus included Antibody Discovery & Engineering, Bispecific Antibody Development, Characterization of Biotherapeutics & Vaccines, Cell & Gene Therapy, Biotherapeutic Expression & Production, and Process Technology & Innovation.

The Pursuit of Better Outcomes with New Biologic Therapies

While monoclonal antibody (mAb) therapeutics comprise the majority of new biologics, new modalities are being developed to better treat patients and improve disease outcomes. These new therapeutic modalities may specifically target solid tumors, decrease off-target effects resulting in lower toxicity, and recruit the body’s immune system to express proteins that fight chronic disease.

Many of these new biologic therapies are designed and built as individual components before they are assembled to form active drug products, unlike small molecular weight (SMW) drugs or a specific mAb. This provides added therapeutic utility; for biologics such as antibody drug conjugates (ADCs), bispecific antibodies, mRNA vaccines, and cell and gene therapies, it also increases the complexity of manufacturing. The added complexity often requires multiple bioanalytical techniques for measuring toxicity and intended therapeutic effects.

While Luminex assays are well known in drug discovery, several sessions discussed xMAP^® Technology also being used in process development and manufacturing stages for mRNA vaccines. xMAP’s ability to measure hundreds of proteins or genomic targets in a sample provides unmatched comprehensive analysis on a single platform. Custom built Luminex assays—particularly those that measure specific impurities and residual host-cell proteins—also provide greater utility for reliably assessing the safety of these new biologics.

Updated Regulatory Guidelines

Another hot topic at the conference was the response from regulatory agencies, such as the FDA and EMA, to these novel biologics therapies. These regulatory agencies are updating guidance documents in both the USA and Europe, and are working with industry sponsors to clarify parameters for the proper manufacture, quality characterization, and safety assessment of these new therapies.

For Research Use Only. Not for use in diagnostic procedures.