Progress in drug design has led to the development of new molecules. However, the limited ability to selectively deliver these molecules at well-defined dosing regimens and screening them remains a significant challenge. Therefore, the development of effective therapies relies on the development of effective carriers that are nontoxic, able to carry a significant payload of the molecule, with high accuracy, and which allow combination therapeutic platforms. Microfluidics is a technique which deals with flow of fluids within micron-sized channels. It provides a platform where nanomedicines can be synthesized in a controlled manner enabling to tune their size, charge, polydispersity, and other surface fictionalization properties. In addition, the technique is energetically economical, easier to use, comparatively cheaper, and faster, and also the molecules which haven’t been incorporated in the particles can be reused. The talk will cover the manufacturing of polymer-based and lipid-based Nanomedicines using microfluidics and comparison with traditional formulation methods. Moreover, the manufacturing of lab-on-a-chip by 3D printing for drug screening will also be discussed.

Speed of formulation development of early-stage biologics is critical for regulatory filing and first in-human dose. Platform formulations are often implemented to meet the accelerated timelines for Phase I formulation development of standard monoclonal antibodies. However, for other modalities like bispecific antibodies, additional buffer/excipient screening might be needed to get a stable formulation. Here, we will discuss a case study for formulation development of a hydrophobic bispecific antibody.

The COVID-19 pandemic has shown how critical formulation and stability are for equitable access to vaccines. Stable presentations that are easy to distribute and administer are essential to make these vaccines available to all people who need them, both in outbreak situations and for routine immunization. CEPI is investing in novel presentations, such as microarray patches and solid dosage forms, to improve equitable access to vaccines.

• Addressing current formulation challenges
• Improving drug stability and safety
• The future of drug delivery: emerging trends and technologies​​

The application of surfactants, mainly polysorbates, is a common practice to prevent surface- or agitation-induced protein aggregation in liquid formulation. However, polysorbates, despite their common application, bring along disadvantages, including chemical and enzymatic instability. This presentation will provide an overview of the protein-stabilising capability of surfactants against agitation- and interface-induced stresses, and corresponding assays for its evaluation. Furthermore, a focus is set to alternative surfactants suitable to replace polysorbates.

Excipients and excipient mixtures within liquid and lyophilized biopharmaceutical formulations are mainly identified based on screening or heuristic approaches. Physically-sound modelling approaches, especially predictive modelling approaches, are desirable to identify excipients and excipient mixtures based intermolecular interactions in solution. We will present a novel approach, considering water activity/water activity coefficients as criteria to determine the optimal excipient mixture for a given liquid/lyophilized formulation in an early development stage.

Biopharmaceutical companies utilise Advanced Kinetic Modeling (AKM) to ensure the stability and efficacy of delicate biomolecules during storage and transport. Following quality-by-design principles, AKM predicts long-term shelf-life based on accelerated stability studies. Evaluated across various biotherapeutics and vaccines, AKM demonstrates accurate stability forecasts up to 3 years, confirming its universal reliability for diverse products, even those with temperature excursions.

We've developed a rapid platform for predicting the long-term degradation of polysorbates in protein therapeutic formulations, crucial for preventing denaturation and aggregation. Using a temperature-dependent equation derived from existing PS20 degradation data, we accurately forecasted PS20 and PS80 hydrolysis for up to 2 years within just 2 weeks of short-term kinetics studies. This platform significantly expedites the assessment of PS degradation, aiding in refining purification processes and optimising antibody formulations.

Formulation is an integral part of drug product development. Platform formulation approaches are often used for specific types of therapeutic modalities to ensure efficient “fast-to-clinic” development. At the same time there are increasing demands for convenient patient-centric products that may require innovative formulation approaches. The talk, which will include several case studies, will demonstrate benefits of innovative formulation and address the balance between routine vs. innovative formulation.

A key challenge to the cost and stability of monoclonal antibodies (mAb) is in the control of host cell protein (HCP) impurities. HCPs often co-purify with the desired mAb product and can impact the stability of the final mAb protein product. Here, we explore established and new techniques for HCP mitigation that could be implemented in the future to improve the quality and stability of the final mAb drug product.

In this presentation, we will discuss cutting-edge Platform Polymer Technologies tailored for the targeted treatment of solid-tumor cancers. Delving into druggable targets, our exploration advances the frontier of therapeutic possibilities. Join us for insights into groundbreaking strategies that promise enhanced precision and efficacy, heralding a new era in advanced cancer therapeutics.