How To Develop Sterile Drug Products for Subcutaneous Use for 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.

Register Free: 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).

Key Learning Objectives:

• Increase understanding of the challenges associated with pharmaceutical development and manufacturing of sterile products for subcutaneous use, especially:
  • High-protein–concentration liquid formulation development
  • Injection device selection
  • Drug-device integration
  • 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.

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
• CMC Consultants

Speaker:

Michael Adler, PhD
Director, Drug Product Design
ten23 health

Michael Adler, PhD, 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.

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