| |
|
|
|
Xtalks, Online
2024-11-13
Blow-Fill-Seal (BFS) advanced aseptic technology offers liquid drug products and vaccines significant advantages over traditional glass vials, such as cost efficiency, transportability and improved environmental sustainability.
However, transitioning to BFS also presents challenges, including the need to design suitable BFS containers, validate the technology for specific formulations and adapt to evolving regulatory requirements. In addition, the design of BFS prefilled drug delivery systems must be tailored to the specific needs of the drug product or end user.
This webinar outlines the essential technical considerations and strategic approaches necessary to successfully transition pharmaceutical drugs and/or vaccine products into BFS drug delivery systems — whether vial or prefilled injectors. It details the importance of understanding material compatibility, optimizing process parameters and assessing impact on the injectable product’s stability and integrity. By identifying and addressing potential issues through prototyping and feasibility studies, drug sponsors can ensure that the BFS drug delivery system meets user requirements and quality standards.
Additionally, this webinar highlights key considerations for evaluating drug or vaccine formulation, packaging, regulatory filings and biowaiver requests when developing combination products using BFS technology. This comprehensive approach is critical for successful product development and regulatory approval.
Enhanced BFS technology has the capability to handle a diverse range of injectable products such as temperature sensitive biologics, vaccines, peptides and small molecules and offers numerous advantages over traditional glass vials.
By addressing technical considerations, leveraging prototyping and feasibility studies and implementing a well-informed regulatory strategy and knowhow pathways, the transition from glass to BFS can be effectively managed and efficient product life cycle management can be maintained.
Register for this webinar today to learn how BFS can revolutionize drug delivery systems and streamline drug development and approval processes.
Keywords: Medical Device, Drug Delivery, Clinical Research, Pharmaceutical Packaging, Vaccines, Packaging, CMC, Combination Product, Injectable, Medical Device Development, Sterile Injectables, API/Formulation Development
|
|
|
|
|
|
|
|
Organized by:
|
|
Xtalks |
|
|
Invited Speakers:
|
|
Christian Eichhorn, PE, Vice President, Process Development & Packaging, ApiJect
Joseph Wojcik, MBA, PMP, Senior Director, Pharmaceutical Services, ApiJect
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
2024-11-13
|
|
|
|
|
|
|
|
Registration:
|
|
Free Registration
|
|
|
E-mail:
|
|
tristan@xtalks.com
|
|
|
|
|
|
|
|
|