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Toward Redosable Gene Therapy: Engineering AAVs to Evade T‑Cells
Adeno-associated virus (AAV) vectors are widely used in gene therapy because of their ability to enable long-term transgene expression with favorable safety profiles. However, immune responses to the AAV capsid remain a major barrier, limiting treatment durability and the feasibility of repeat dosing. A recent Nature Communications study led by Dr. Ronit Mazor and colleagues…
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Beyond Impurities: Why Today’s Biologics Need Smarter Particle Analysis
Particle analysis is not just a requirement in biopharmaceutical development—it’s a critical component that can make or break the safety and efficacy of your drug. When developing protein therapeutics, particles like aggregates over 1 µm must be defined and monitored, while in delivery systems, even the vehicles themselves—cells or viruses—qualify as particles. Ignoring or mismanaging...
Why Compliance with USP 789 is Essential for Pharmaceutical Manufacturers
Ensuring the safety and quality of pharmaceutical products is a critical responsibility for manufacturers. The United States Pharmacopeia (USP) plays a pivotal role in setting the standards that safeguard patient health and uphold product efficacy. Among these, USP 789 specifically addresses particulate matter in ophthalmic solutions, emphasizing the importance of maintaining stringent quality controls to...
Optimizations in High-Throughput Process Development: Enhancing Efficiency and Precision
High-throughput process development (HTPD) refers to the systematic approach of performing numerous experiments simultaneously to expedite the optimization and development of biopharmaceutical processes. This innovative methodology significantly transforms and accelerates how scientists, clinicians, and engineers tackle the challenges associated with bioprocess development. By employing HTPD, organizations can accelerate process optimization, reduce operational costs, and improve...
Advances in Exosome Quantification Techniques
The study of exosomes has gained substantial attention in recent years due to their significant potential in diagnostics, therapeutic applications, and as biomarkers for various diseases. Exosomes, which are extracellular vesicles (EVs) ranging from 30 to 150 nm when stable and in solution, are secreted by various cells and carry molecular signals like proteins, lipids, and RNAs to recipient cells....
OligoWorks SPE Kits: Boosting Oligonucleotide Bioanalysis Efficiency
New OligoWorks Solid Phase Extraction (SPE) Kits for extraction and bioanalysis of oligonucleotides deliver advantages over liquid-liquid extraction (LLE) and other existing SPE kits and sample preparation methods. Read on to discover how.
Gene and Cell Therapy Commercialization Advances, Challenges, and the Path to Success
Cell and gene therapy appear poised to revolutionize drug and vaccine discovery, with the potential to address diseases that have been untouchable, and treat others with more successful therapies. But the road to success has been rocky, and many obstacles remain for both gene and cell therapy commercialization. A Look Back: The History of Gene Therapy Therapeutic Targets Gene...
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