Dose Administration, Compatibility, and Clinical Usability of Biologics

This webinar will focus on multiple facets concerning the administration of biological drug products and product quality. It will touch on topics like designing studies to fit MABEL, diluent compatibility, lean and efficient study designs incorporating various administration container materials, diluent choice, equilibration and hold-time procedures. It will include selecting appropriate filter types, handling steps, potential impacts on dose, microbial sterility and product interactions. Additionally, it will explore analytical method requirements and the application of closed system transfer devices (CSTDs).

Register Free: https://www.pharmtech.com/pt_w/dose-administration

Event Overview:

Biological drug products (DPs) need to maintain product quality during administration to ensure patient safety, considering diverse administration conditions across various clinical sites and hospitals. Key aspects involve handling procedures, DP compatibility with the administration container, assessing product quality and stability during hold time and administration, ensuring sterility, and verifying accurate dosage delivery. The focus on CSTDs with biologics has increased recently, possibly affecting dose delivery and drug product compatibility.

Key Learning Objectives

• IND section P.2.6
• Phase-appropriate drug development
• MABEL design and in-use studies
• Biocompatibility
• Protein aggregation
• Physico-chemical stability of DPs during administration
• CSTDs
• IV bags
• Microbial stability under in-use conditions
• Handling DPs in pharmacies
• The Pharmacy Manual for preparation and administration of DPs

Who Should Attend

• CEOs
• CMCs/product team leaders
• R&D managers
• R&D scientists
• Regulatory affairs specialists
• Formulation development scientists and managers
• Drug product scientists and managers
• Analytical scientists and managers
• Sterile production managers
• CMCs Consultants

Speakers
Professor Hanns-Christian Mahler, PhD
Chief Enablement Officer
ten23 Health

Adithya (Adi) Balasubramanian, MS
Business Development and Sales
ten23 Health

Register Free: https://www.pharmtech.com/pt_w/dose-administration