Thursday 18th September - Main Conference Day ThreeThursday, 18 September 2025 - ET (Eastern Time, GMT-05:00)

This talk will focus on the steps and procedures necessary to produce a drug product, starting with a biologic drug substance. This is the final step in drug manufacture and the only set of procedures that must be done aseptically. The typical testing procedures for drug product will also be discussed.

• Case study on challenges with formulating high concentration biologics – particularly emerging biologics

• Improve viscosity to avoid issues with syringe ability and injectability - development of specialized delivery devices

• Optimising buffer systems and excipient usage

• Maintaining homogeneity

• Storage and temperature challenges

Patient convenience and the need for self-administration are fueling the demand for prefilled syringes and autoinjectors for biologics, requiring specialized formulation and fill finish capabilities.

Subcutaneous delivery of biologics via self-dosing devices is increasingly essential for chronic disease management, yet development remains slow and costly—often requiring years and tens of millions of dollars due to formulation redevelopment and complex clinical trials. A key barrier is the disconnect between drug and device development, regulated under separate frameworks (21 CFR 210/211 vs. 820). This talk introduces an integrated approach for drug and device development from project inception to commercial launch and provide effective toolboxes along the development phases.