In this free webinar, learn about the technical factors involved in transitioning drug products, including material compatibility, process parameters and their effects on drug stability and integrity. Attendees will gain insights into identifying and resolving potential issues by using prototyping and feasibility studies to ensure the blow-fill-seal (BFS) system meets necessary performance and quality standards. The featured speakers will share considerations when assessing drug or vaccine formulation, packaging, regulatory filings and biowaiver requests for combination product development via BFS technology.
TORONTO, Oct. 23, 2024 /PRNewswire-PRWeb/ — 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.
Join experts from ApiJect, Christian Eichhorn, PE, Vice President, Process Development & Packaging; and Joseph Wojcik, MBA, PMP, Senior Director, Pharmaceutical Services, for the live webinar on Wednesday, November 13, 2024, at 1pm EST (10am PST).
For more information, or to register for this event, visit Transitioning Drug Products or Vaccines into a Prefilled Blow-Fill-Seal Drug Delivery Device.
FORWARD LOOKING STATEMENT
This press release contains forward-looking statements within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included in these materials that address activities, events or developments that ApiJect expects, believes or anticipates will or may occur in the future are forward-looking statements. Forward-looking statements contained in this press release specifically include the expectations of plans, strategies, and objectives of ApiJect. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of ApiJect, which may cause actual results to differ materially from those implied or expressed by the forward-looking statements.
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