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Explore our library of resources to discover valuable insights on the latest trends in drug delivery.
The Kindeva Advantage: Setting the Gold Standard for Elemental Impurities Testing
In this blog, Jen Roark, Scientific Director of Injectables at Kindeva, explores the challenges of controlling elemental impurities in drug products. She breaks down the risks and regulatory guidelines outlined in USP <232> and ICH Q3D, then takes a deep dive into the findings of a recent PQRI interlaboratory study that highlights the complexities of […]
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A bridge to the future: Our world-class Bridgeton facility
Manufacturing sterile injectables today is more complex than ever. Navigating stringent aseptic requirements, evolving regulatory expectations and the need for significant specialized investment has made the path to market increasingly challenging. A fragmented approach across development, drug substance manufacturing and fill finish remains a common industry practice that can introduce critical vulnerabilities. With every handoff, […]
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Mastering USP 661.1 and 661.2: Kindeva Drug Delivery Simplifies Your Path to Compliance
Understanding the evolution of USP <661.1> and <661.2> In this blog, Jen Roark, Scientific Director of Injectables at Kindeva, breaks down the critical shift in pharmaceutical packaging standards ahead of the fast-approaching December 1, 2025, implementation deadline. She covers the history of USP <661.1> and <661.2>, the move to a risk-based framework, specific testing requirements […]
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The impact of inlet design on HFA-152a pMDI drug delivery
When assessing aerodynamic particle size distribution (APSD) using the Next Generation Impactor (NGI), throat model selection can significantly influence drug deposition outcomes. Accurate deposition data is essential for optimising pMDI design and ensuring consistent, effective drug delivery to patients. Recent research by our pulmonary/pMDI experts—Aaron Taylor, Chad Haraldson, and Stephen Stein at Kindeva—explores how United […]
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Evaluating extractables in low-GWP pMDI formulations
As the pharmaceutical industry advances toward low global warming potential (GWP) propellants like HFA152a and HFO1234ze(E), understanding material compatibility becomes critical, especially when it comes to leachables from common device components. In a recent evaluation, a group of pulmonary experts at Kindeva assessed the extractable levels associated with various polybutylene terephthalate (PBT) suppliers in pressurized […]
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The three key trends that will most impact drug development in 2025
The speed of change in the drug development and manufacturing sector requires its stakeholders to be proactive in understanding and addressing key trends and directions the industry is taking. As a global market of considerable size and significance, the value of which is anticipated to grow from $589.06 billion in 2024 to $632.71 billion in […]
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Microneedle array patch characterization recording
Microneedle array patches (MAPs) have the potential to transform delivery of medications and vaccines. While this innovative drug delivery format could result in improved efficiency across a wide range of therapeutics, it also brings critical challenges. To successfully move from concept to commercialization, MAP manufacturers must consider scalability, regulatory compliance, and other complexities. In this […]
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Microneedle array patch characterization presentation
Microneedle array patches (MAPs) are a transformative innovation in drug delivery, with the potential to redefine how medications and vaccines reach patients. MAPs promise a simpler, more effective way to deliver a wide range of therapeutics, but their journey from concept to commercialization is filled with critical challenges. From scaling manufacturing to ensuring regulatory compliance, […]
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Addressing top tech transfer challenges
Technology transfer represents a critical bridge between development and commercial manufacturing. This complex process — moving product and process knowledge between development and manufacturing teams or between different manufacturing sites — demands precision at every stage. The implications of technology transfer extend beyond knowledge sharing. Each decision during this process directly impacts manufacturing efficiency, regulatory […]
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