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A bridge between design and delivery: Exploring sterile fill finish integration for injectable product success
The global sterile injectable contract manufacturing market is experiencing rapid growth, driven by increasing demand for advanced biologics, glucagon-like peptide-1 (GLP-1) therapies and other injectables. These products pair drugs with delivery devices to support patient-centric care, but their manufacturing presents unique challenges. Programs often require specialized environments, such as cold-chain storage and low-volume fills, and […]
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Going beyond manufacturing: The Kindeva customer experience
Going beyond manufacturing: The Kindeva customer experience As development timelines tighten and product complexity grows, the quality of CDMO partnerships has transformed into a critical success factor. In today’s high-stakes landscape, drug developers need more than technical execution. They need partners who embed early, stay aligned and help navigate every phase of the product lifecycle. […]
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Built for better tomorrows: How Bridgeton delivers for patients
Kindeva’s Bridgeton facility offers a purpose-built solution for the complex and evolving landscape of injectable drugs. The facility was specifically designed to address challenges in sterile injectable manufacturing, such as the siloed approaches that often separate core functions like formulation and fill finish. By co-locating these functions and operating within integrated systems, the Bridgeton model […]
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Building confidence into complex drug-device programs with early analytical expertise
Drug-device programs are under pressure to do more, with tighter timelines, deeper scrutiny and increasing complexity. As teams move from concept through clinical and commercial phases, one challenge remains constant: ensuring products behave as intended, consistently and safely. That challenge gets more complicated as formulation, device mechanics, packaging and regulatory expectations converge. Whether developing an […]
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What makes Bridgeton the perfect partner for your next sterile fill finish project?
The pharmaceutical sector is experiencing a significant increase in the demand for advanced biologics, biosimilar therapies and other sterile injectables. As a result, the global sterile injectables market is projected to grow from $632 billion in 2025 to $1.078 trillion by 2032, with a compound annual growth rate of 7.9% [1]. In response to this […]
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From vial to value: How GLP-1s are redefining injectable care for chronic conditions
The market for glucagon-like peptide-1 (GLP-1) therapies is growing rapidly, with a projected value of $186.6 billion by 2032. Originally developed for diabetes, these therapies are now widely used for obesity treatment, which has created a need for convenient and scalable delivery systems. This growth is reshaping the industry, creating new demands on manufacturing capacity […]
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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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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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