SPEAKER: Ahmad Sediq
ROOM: Rivoli C
CONTACT HOURS: 1
CRNI RUs: 2

Biological drug products (biologics) that contain, among others, proteins and monoclonal antibodies can only be administered parenterally (mostly, via an injection or infusion). Development of an injectable product, especially for biologics, is a lengthy and expensive process. This is related to the sensitive nature of biologics and the aim of having a user-friendly product that can ideally be administered at home by the patient directly. This presentation aims to provide deeper understanding about how development of biologics is designed in order to meet user requirements and capabilities. The product development process ranging from typical vialed product up to products coming in devices (such as auto-injectors or within body injection devices) will be outlined. The importance of understanding the product use and limitations will be highlighted to enable continuous improvement of the products and development strategies. 

Learning Objectives: At the conclusion of this session, learners will be able to: • Discuss the properties of biologics that are important for the therapeutic outcome • Discuss crucial parts in the development of biologics that are tailored to enable optimal product use • Explain how multidisciplinary interactions improve the value of the product for the end-users