Downloads
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Implementing Medium And High-Volume Drug Handling And Packaging Programs
4/23/2026
Simplify the complexity of combination product development by partnering for integrated support across device design, industrialization, manufacturing, and final product assembly.
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Don't Just Launch Your Molecule, Protect It!
4/23/2026
Accelerate your path to market with integrated support to streamline processes, reduce delays, and deliver safe, user-friendly drug-delivery solutions.
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Providing Solutions In Titer, Host Cell Protein, And Scalability
4/23/2026
By leveraging expertise across a global network and executing a streamlined, rapid technology transfer, see how we were able to enable a highly data-driven approach to clone selection and process optimization.
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Selecting The Right eQMS To Maximize Quality Maturity
4/23/2026
Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.
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Do Changes Signal The End Of Biosimilar Regulatory Redundancy?
4/23/2026
First came excitement over the looming patent cliff. Then, FDA and EMA took big swings at what many have called redundant work. Combined, they make a more attractive environment for biosimilar developers.
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How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT
4/23/2026
Patient access often gets mischaracterized solely as a cost and pricing issue. A discussion among industry leaders reaches a deeper, more complex conclusion.
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Quality By Design Understanding And Securing Virus Clearance
4/22/2026
Data-driven virus clearance improves risk assessment, process insight, and study design. Learn how Quality by Design cuts late-stage risk while strengthening regulatory confidence and viral safety.
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Tech Transfer Roundtable: Real World Lessons From Rentschler Biopharma's Experts
4/22/2026
Real‑world lessons for planning and executing tech transfers, with practical insights on early alignment, process readiness, risk reduction, and cross‑functional coordination for smoother scale‑up.
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FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing
4/22/2026
The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.
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Validating Candel's BLA-Ready Analytics Profile
4/22/2026
The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.