Main Conference Day 2Wednesday, 4 November 2026 - Europe/Amsterdam

This presentation will review the recent evolution of global regulatory guidance for synthetic oligonucleotides, assess areas of convergence and divergence, and explore future opportunities for harmonisation and efficiency.

CMC regulatory strategies and health authority interactions for oligonucleotide programs will be discussed, with a focus on recent ASO commercial applications in the US and ex-US regions. Similarities and differences in submission content, filing strategies, regulatory expectations, and health authority requests will be highlighted, supported by recent filing experiences and case studies. Perspectives on emerging hot topics and practical learnings from recent submissions will be discussed, along with potential future areas for regulatory engagement.

The presentation will provide an update on the main principles and current status of guidelines and the expected timelines for implementation. It will summarise key feedback received during the public consultation of two draft guidelines, with a focus on the main scientific and regulatory challenges for stakeholders. The presentation will also provide an overview of the most common issues encountered during Marketing Authorisation Application procedures in recent years.

We have demonstrated that cys-rich miniproteins (“knottins”) can be inserted into the CDR loops of an antibody to create a fusion molecule combining the specificity of the knottin and the benefits of an antibody. The format facilitates the use of phage display technology to engineer the affinity and specificity of the knottin. This will be exemplified using a variety of ion channel modulating knottins

We screened a library of 3.2 million cyclic peptides intracellularly using SICLOPPS. Following a high throughput phenotypic screen we identified CP25, which displays synthetic lethality to MTAP deletion cells via the axis of metabolic vulnerability. Target ID work has identified on target effects, via RNA processing enzymes. We anticipate that our workflow can be applied to a variety of diseases, greatly accelerating the rate of drug discovery.

Fibrosis is a hallmark of many chronic diseases, associated to nearly 45% of all deaths in the industrialized world. Despite its significant impact on global health, effectively delivering therapeutics to these tissues remains challenging. This talk will discuss a novel targeting modality, offering a new perspective on drug-delivery to fibrotic tissues.

Regulators increasing expect terminal sterilization for ASO drug products by steam/autoclave as a process that offers high sterility assurance levels (≤10^-6). Aseptic processing is only allowed if steam sterilization is not feasible. Published ASO data to date (DeCollibus et al 2023) largely focus on molecule-centric, concentration-based chemical degradation, such as depurination and backbone cleavage/hydrolysis, with limited evaluation of the formulation aspects. EMA draft guidance (EMA/CHMP/CVMP/QWP/262313/2024) states that moderate degradation, even above qualification limits, is not enough to reject terminal sterilization. Instead, the guideline encourages optimizing formulation factors (pH, buffer system, and osmolality), and container-closure to enable its use. With advancements in ASO chemical modifications and molecule designs, formulation composition may emerge as a potentially limiting factor. This presentation will illustrate some case studies under such circumstances to help make informed decisions on feasibility of steam sterilization during early phases of ASO drug product development.

Posttranslational modifications (PTMs) have a critical role in shaping peptide structure and function. This talk highlights conotoxins as model small, structured bioactive peptides to explore how PTMs influence folding, stability, and biological activity. Insights from these systems inform rational peptide design, and synthesis of modified peptides to understand and harness their biological activities.

α-Conotoxin Vc1.1 is a disulfide-rich peptide and a promising drug candidate for treating neuropathic and chronic pain. Backbone cyclisation was applied to enhance its drug-like properties, resulting in improved serum stability and oral bioavailability. However, this modification also adversely affected its stability and activity in simulated intestinal fluid (SIF). To address these adverse effects, we explored the use of polyethylene glycol (PEG) linkers as substitutes for peptide backbone cyclization linkers.

Aligning requirements between pre-clinical peptide process development, CMC strategy foundation and risk-mitigated tox/Phase I package is the driving force at PolyPeptide. Modern High-throughput and intensified process tools are structuring our offering in the current, fast-moving environment for peptides. Right the first time, reliability and reproducibility for fast transition to clinic are success criteria for shortening time to IND. Our presentation will highlight our technical and commercial platform for peptide development and present technical case studies and examples of IND acceleration for various peptide programs.

In the early phase of drug development for peptide APIs, speed to start Phase I is absolute key. With our early phase development concept, including process and analytical development, we can strongly reduce the time to manufacturing Tox and first GMP material. Synchronized timelines and parallel workflows between drug substance and drug product within our PepCellerate™ platform allows to save time while reducing risks. A case study will be presented.

Disulfide bond formation is a key step in the manufacture of cysteine‑containing peptides, yet established oxidation methods frequently rely on hazardous reagents such as iodine or hydrogen peroxide. These approaches can introduce safety concerns, material compatibility issues, limited scalability, and undesired side reactions including over‑oxidation and oligomer formation. We describe a new oxidation platform based on dehydroascorbic acid (DHA), the oxidized form of vitamin C, as a mild, selective, and sustainable reagent for disulfide bond formation. The method supports efficient oxidation under aqueous conditions and is compatible with both high‑concentration in‑solution processing and an integrated on‑column implementation during preparative HPLC purification. DHA‑mediated oxidation shows a consistently favorable impurity profile and avoids common side reactions observed with conventional oxidants, even for peptides with limited solubility or high aggregation propensity. The DHA‑based platform simplifies process design by enabling higher working concentrations, reducing unit operations, and allowing oxidation to be integrated into existing purification workflows. The use of a non‑hazardous, vitamin‑derived reagent improves operational safety and equipment compatibility while significantly lowering process mass intensity and solvent consumption. Together, these features support robust scale‑up and align peptide manufacturing with modern sustainability expectations, making the technology well suited for both late‑stage development and commercial production.

This presentation describes the end‑to‑end process development of Dapiglutide, highlighting how innovative manufacturing optimization increased overall yield from ~20% to over 60% and enabled robust, scalable, and industrially viable peptide manufacturing from laboratory to large‑scale production.

When the world needs millions of doses of a molecule transforming the treatment of type 2 diabetes and obesity — manufactured to the highest quality standards — manufacturing science becomes a contact sport. This talk draws on the real process challenges of tirzepatide manufacture to extract transferable principles about innovating under pressure — from bench anomaly to breakthrough, and from gram to metric ton.