Main Conference - Day 3 (May 14)Thursday, 14 May 2026

Traditional solid phase peptide synthesis often involves the use of large volumes of a number of challenging solvents and reagents, including polar aprotic solvents, chlorinated solvents, and TFA. Efforts to remove these types of solvents and reagents has led to concerted efforts to investigate alternative platform strategies that both eliminate these chemicals, and also drive down synthesis cost and PMI. Additionally, the synthesis of peptides using purely liquid phase chemistries offers an option to designate more advanced sub-fragments of the peptide with favorable physical properties as potential registered starting materials.

The GLP-1 boom in obesity and metabolic disease has triggered a capacity crunch, hitting emerging biotechs hardest. This talk explores two pressure points in GLP-1 API manufacturing: (1) defining defensible starting materials for complex dual agonists under regulatory scrutiny, and (2) securing scarce development and GMP capacity at CDMOs dominated by big pharma. We share pragmatic tactics to keep small sponsors competitive without sacrificing quality or speed.v

Over the past decade, the pharmaceutical industry has transitioned from traditional small molecules toward complex new modalities, including peptides, antibody-drug conjugates (ADCs), and oligonucleotides. The structural complexity and similarities inherent in these modalities pose significant characterization challenges, requiring analytical scientists to extend the boundaries of modern techniques. While Size Exclusion Chromatography (SEC) and Reversed-Phase Liquid Chromatography (RPLC) are essential for assessing physical stability and chemical purity, one-dimensional chromatography is often insufficient for full characterization. To address this, we have developed an array of multidimensional techniques coupling orthogonal retention mechanisms, such as RPLC-RPLC, RPLC-SEC, SEC-RPLC, and RPLC-HILIC. A primary challenge in these systems is mobile phase incompatibility between dimensions; we address this through a novel interface utilizing In-Line Mixing Modulation (ILMM) for sample homogenization. Furthermore, non-denaturing SEC methods are critical for peptides to preserve native conformation and higher-order structures (HOS), which are essential for biological activity and quality control. Developing these methods is often difficult due to secondary interactions that limits the use of physiological aqueous buffers requiring reasonable amounts of organics. We present strategies to suppress these interactions, enabling separations based on pure hydrodynamic volume. This presentation will highlight the current analytical challenges and the advanced strategies to achieve comprehensive peptide characterization.