Learning Center
How Are Robust and User-Centric Biological Drug Products Developed?
Includes a Live Web Event on 04/28/2025 at 11:00 AM (EDT)
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
Contact Hours: 1
CRNI® RUs: 2
Ahmad Sediq
Ahmad Sediq, PhD, is a pharmacist with a PhD degree in pharmaceutical technology from Leiden University in the Netherlands. Dr Sediq worked as a formulation scientist at Janssen Vaccines in the Netherlands, where he was responsible for late-stage development and commercial launch of adeno-associated virus- (AAV)-vector-based vaccine products for Ebola and human immunodeficiency virus (HIV). He joined Lonza DPS in 2018, where he was principal scientist and group leader in the Formulation Development group. At Lonza, his team was responsible for early- and late-stage drug product development of various biological formats. In 2022, Dr Sediq joined Roche/Genentech, where he is taking the lead of early- and late-stage drug product design and development for treatment of inflammatory bowel disease and lung cancer.
Dr Sediq is interested in applying his technical and scientific knowledge into pharmaceutical care and treatment. Therefore, he is passionate of performing research at the interface of pharmaceutical technology and clinical practice.
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