Ten23 Health

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).

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

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.


Physico-chemical stability of DPs during administration

Microbial stability under in-use conditions

The Pharmacy Manual for preparation and administration of DPs

Formulation development scientists and managers

Business Development and Sales
ten23 Health

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Webinar Date/Time: Mon, Nov 18, 2024 11:00 AM EST


Dose Administration, Compatibility, and Clinical Usability of Biologics

Gain valuable insights into pharmaceutical development for sterile subcutaneous products with this exclusive webinar. Learn about critical development strategies and scenarios for initial launches and lifecycle management. Dive into the technical, preclinical, and clinical bridging required when transitioning from intravenous to subcutaneous administration. Explore the challenges of high-protein–concentration liquid formulations, injection device selection, and drug-device integration. Master the design of your development pathway to ensure your drug product delivers quality, efficacy, safety, patient usability, and competitiveness.

https://www.pharmtech.com/pt_w/subcutaneous-use

Are you looking for insights into pharmaceutical development activities for sterile products for subcutaneous use? Get to know how different development strategies and scenarios apply for initial launch or in life cycle management. This unique webinar will cover technical, preclinical, and clinical bridging from intravenous to subcutaneous administration, as well as aspects if you want to transition from a vial presentation to a patient-centric injection device (eg, prefilled syringe or on-body injectors).



Increase understanding of the challenges associated with pharmaceutical development and manufacturing of sterile products for subcutaneous use, especially:

High-protein–concentration liquid formulation development

Drug product manufacturing process development

Learn the required technical, preclinical, and clinical bridging studies needed when switching from intravenous to subcutaneous administration and/or when transitioning from a vial to subcutaneous injection device;

Learn how to master an optimized the design of your development pathway and roadmap to ensure you have a successful drug product that provides quality, efficacy, safety, patient usability, and product competitiveness.


Director, Drug Product Design
ten23 health

, is currently the director of drug product design at ten23 health in Basel, Switzerland. He has over 20 years of industry experience at different pharmaceutical companies, including Abbott (now AbbVie), Roche, and Lonza. He has vast experience in early- and late-stage formulation and drug product manufacturing process development for both liquid and lyophilised dosage forms. His area of expertise also covers process transfer, process characterization, and validation and commercial support for biological drug products, including combination products and small-molecule parenterals. Dr Adler has driven development of monoclonal antibodies and novel antibody-derived formats, fusion proteins, PEGylated proteins, synthetic peptides, and oligonucleotides for intravenous, subcutaneous, intravitreal, and intrathecal delivery. He has extensive knowledge in regulatory registration activities, as well as health authority interactions for the US, Europe, and other regions. Dr Adler studied pharmacy at the Heidelberg University in Germany and holds a doctor of philosophy degree in pharmaceutical technology from the University of Erlangen-Nürnberg in Germany.

Webinar Date/Time: Tue, Oct 22, 2024 11:00 AM EDT

Ten23 Health

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