Home / Knowledge hub /
Webinar | A Bridge to the Future of Aseptic Manufacturing: A Pharma 4.0 Case Study
January 15, 2026
Growing demand for high-quality sterile fill finish capacity is putting pressure on development timelines and supply programs across the industry. As expectations for Annex 1 alignment, agility and data-driven control rise, partners need facilities designed to keep pace with evolving requirements.
In this on-demand webinar, Chad Hafer, Director of Technical Operations, Aseptic Fill Finish at Kindeva, walks through the thinking behind the Bridgeton sterile fill finish campus. He explains how Pharma 4.0 concepts and the Annex 1 draft informed our approach, and what that meant for building a site that can keep pace as expectations evolve.
Watch Chad’s full talk to learn more about:
- The design principles that shaped our Bridgeton facility
- The role of automation and interconnectivity across our aseptic manufacturing
- How we built in flexibility and scalability from day one
- Our approach to supporting vials, prefilled syringes and cartridges, delivering close to 100% OTIF to our customers
Access this content
Fields marked with a * are required.
Related resources
Explore our other resources to discover valuable insights on the latest trends in drug delivery.
Sterile fill finish Q&A: What should sponsors ask before manufacturing begins?
Successful sterile fill finish depends on decisions made long before a product reaches the filling line. Process understanding, technology transfer strategy, contamination control and commercial readiness all influence how confidently a program can progress into Good Manufacturing Practice (GMP) manufacturing. In this Q&A, Kindeva experts share practical perspectives on the questions pharmaceutical and biotech teams […]
Learn MoreWhy successful technology transfers can start by slowing down
Technology transfer programs often face pressure to move quickly, but rushing through the early stages can lead to costly execution delays when teams start before internal alignment is complete. By slowing down, teams can streamline the process, ensure alignment from the start, and challenge assumptions before the transfer begins. In other words, slow is smooth; […]
Learn MoreBridging the gap between upstream precision and downstream excellence in aseptic fill finish
The pressure to bring complex therapies, including biologics and glucagon-like peptide-1 (GLP-1) agonists, to market quickly has placed a significant strain on commercial production networks. As drug developers respond to growing demand for these therapies, the transition from bench top discovery to commercial aseptic fill finish volumes can happen quickly. But, when upstream processing scales […]
Learn MoreTurning media fill data into stronger aseptic control in an Annex 1 era
Media fills provide an important demonstration of aseptic process performance, as the information gathered during a simulation gives manufacturers a stronger understanding of how the process behaves over time. As companies must now translate their media fill processes to meet Annex 1 expectations, the way this information is reviewed can provide valuable insight into aseptic […]
Learn MoreRethinking media fill strategy in the Annex 1 era
Media fills play a central role in aseptic process validation, providing a practical demonstration that a manufacturing process can be carried out without introducing microbial contamination. However, under the revised EU GMP Annex 1 guidance, the focus has shifted, and an acceptable final incubation result is no longer sufficient on its own. Now, media fills […]
Learn MoreWhat’s behind the decisions shaping successful fill finish programs?
Advanced equipment and available cleanroom capacity are important considerations when choosing a sterile fill finish CDMO partner, but they only form part of the decision. As a drug program nears cGMP manufacturing, careful consideration of technical, quality, and operational readiness is essential, as it shapes how confidently a program can progress. These considerations take place […]
Learn MoreBuilding sterile injectable manufacturing capacity for growing GLP-1 demand
Glucagon-like peptide-1 (GLP-1) receptor agonists are being prescribed more frequently, increasing pressure on sterile injectable manufacturing networks. To effectively serve expanding patient populations, developers must increase output while maintaining product quality and regulatory compliance without disrupting the supply of other therapies. Meeting the growing GLP-1 demand requires manufacturing models that can manage high-volume programs alongside […]
Learn MoreMeeting the challenges of fill finish manufacturing
How flexible infrastructure and early manufacturing expertise can help drug developers respond to changing demand With rising demand for glucagon-like peptide-1 (GLP-1) medicines, continued progress in biologics and the expansion of self-administered treatments, new expectations are being placed on sterile fill finish operations. Manufacturers must accommodate different container formats and production volumes while maintaining consistent […]
Learn MoreCan one quality system manage complexity across multiple drug delivery platforms?
As drug development portfolios expand across multiple delivery platforms, increasing complexity places quality systems under greater strain. For sponsors considering a CDMO, it is essential to know that the Quality Management System (QMS) can provide consistency while allowing teams to respond appropriately to the requirements of each product. A harmonized QMS can provide that framework […]
Learn MoreLet’s transform tomorrow together
Every patient deserves a brighter tomorrow. As your strategic partner, we are dedicated to building your lasting legacy and helping you fast-track healthier tomorrows. You dream it, we deliver it.