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Explore our library of resources to discover valuable insights on the latest trends in sterile fill finish.
Webinar | Beyond the filling suite: How modular facility design supports sterile manufacturing success
Sterile manufacturing requirements are fast evolving, which means that many organizations are reassessing whether their legacy facilities can support future operational and regulatory demands. In this webinar, John Wichelt, Vice President and General Manager at Kindeva’s Bridgeton site, explores what a modern sterile fill finish facility needs to look like in this new era. Drawing […]
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Q&A: Navigating tech transfer and production pitfalls
Successful tech transfer alignment requires robust risk management and precise operational planning. When communication gaps or unforeseen supply chain hurdles emerge, project timelines and product quality are often the first to be affected. In this Q&A, we explore the common pitfalls of pharmaceutical tech transfers, including how to protect critical milestones without compromising safety and […]
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What does Annex 1 mean for sterile drug product manufacturing?
Annex 1 compliance remains a key priority for companies working in sterile drug product manufacturing. But recognizing how fundamentally expectations around sterility assurance have changed may be the most significant challenge companies face. Revisions to the EU GMP Annex 1 requirements now move beyond individual compliance activities and place greater emphasis on how contamination risks […]
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Video tour | Explore Kindeva’s US manufacturing network
As a purpose-fueled, people-centric drug delivery CDMO, we are dedicated to advancing programs that help fast-track healthier tomorrows. Our US facilities play a vital role in delivering this commitment, providing specialized environments, technical depth and operational excellence that extend beyond manufacturing. Our US sites are strategically located and designed to support complex drug delivery programs […]
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Explore our world-class sterile injectable facility in Bridgeton, Missouri | Video tour
Spanning over 155,000 sq. ft. of dedicated aseptic operations space, our Bridgeton, MO facility brings together leading expertise, advanced automation and Annex 1-compliant isolator technology to help support growing global demand for sterile injectables. Designed to deliver excellence from floor to ceiling, Bridgeton seamlessly connects development and delivery through flexible fill finish infrastructure that helps […]
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