Articles, App Notes, Case Studies, & White Papers
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Staying On Top Of Changing FDA Regulations To Avoid Clinical Holds
8/14/2023
As the biotech industry has grown exponentially, so has the number of FDA clinical holds. Biotech companies need strategic planning to avoid or quickly resolve costly clinical holds.
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Is Standardization The Key To Scalable CGT?
3/2/2026
Experts note CGT programs often struggle due to limited operational readiness; early standardization supports scalable, reproducible, regulatory‑ready development and helps prevent late‑stage bottlenecks.
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Overview Of COVID-19: Global Clinical Trial Landscape
12/27/2024
Explore how COVID-19 has led to significant global morbidity and mortality. Advances in vaccines, therapies, and clinical trials are enhancing disease management and outcomes.
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How To Make The Best LNPs
1/22/2024
There are various factors that require careful consideration throughout the process of formulating LNPs and utilizing them for successful mRNA delivery and translation.
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Optimization Of Midstream Cell Lysis And Virus Filtration Steps In An Adenovirus Purification Process
9/10/2018
Here we describe screening of detergents for release of adenovirus from HEK293 host cells to replace the traditionally used detergent Triton™.
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Triple-Negative Breast Cancer: Global Clinical Trial Landscape
1/30/2025
With over 1,500 TNBC-focused clinical trials since 2019, research efforts into Triple-negative breast cancer (TNBC) treatments are accelerating despite challenges such as drug resistance.
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How Lipid Nanoparticles Enable Next-Gen Delivery
10/20/2025
Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.
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How A New Factory-In-A-Box Is Helping Scale Up Manufacturing Of Viral Vector Based Therapies To Reach More Patients
8/31/2018
Manufacturing viral vector-based therapies such as vaccines and gene and cell therapies is complex, but a new manufacturing solution helps solve those challenges.
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Why Shipping System Qualification Matters In Advanced Therapies
12/2/2025
Ensuring the integrity of advanced therapies requires documented evidence of robust shipping processes. Qualification is essential for compliance and maintaining continuity across the supply chain.
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Genome Editing of Human Primary T Cells With Lipid Nanoparticles
4/18/2022
We show CRISPR/Cas9-mediated knockouts of the T cell receptor and explore multi-step LNP engineering to produce TCRɑβ KO CAR T cells, a promising approach towards allogeneic CAR T cell therapy.