Transitioning Drug Products or Vaccines into a Prefilled Blow-Fill-Seal Drug Delivery Device

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.

Speakers

Christian Eichhorn, PE, Vice President, Process Development & Packaging, ApiJect

With over 17 years of experience in process and packaging development, Christian Eichhorn heads the process development and packaging disciplines at ApiJect, defining strategy while directing and applying technical expertise to projects across the product development lifecycle.

His prior experience includes over 12 years with West Pharmaceutical Services, leading engineering teams that conceptualized and developed new products and integrated new technologies. Leading the Containment Expansion R&D team, he focused on the development of new product concepts through external collaborations and integration of technologies such as additive manufacturing, novel containment and advanced materials.

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As part of West R&D, he founded a new team to expand and centralize analytical engineering capabilities like mold flow simulation and finite element analysis to support the rapid development of new container systems. He co-led the creation and rollout of West’s Innovation Playbook, an internally developed best practice guide and collection of tools to assist colleagues around the globe apply innovation best practices in their work.

While at Parsons Corp., Christian was Process/Project Engineer for several life sciences design building projects, including a 2011 ISPE Facility of the Year award-winning biologics production facility.

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Joseph Wojcik, MBA, PMP, Senior Director, Pharmaceutical Services, ApiJect

As leader of the Pharma Development Team, Joseph Wojcik is responsible for overseeing the successful completion of client development projects, from lab-scale early phase through late-stage development. In addition, he manages client engagement and provides support for combination device programs, including non-GMP feasibility, drug product formulation and compounding and business planning to help clients achieve their goals.

With over 17 years of experience in drug development and delivery, Joe specializes in formulation, tech transfer, fermentation, purification, sterile-filtration and product development in blow-fill-seal (BFS) technology. He is considered a Subject Matter Expert at ApiJect and has played a role in designing and building an automated particulate inspection machine for the company’s novel drug delivery device for sterile injectables. In addition, he supported the launch of a BFS Technology Development Center.

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