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Designing Analytical Methods for Long-Term Audit Readiness

Reading Time: 6 minutes

Audit readiness isn’t a last-minute activity triggered by validation or inspection. It’s established much earlier, at method design, through the scientific understanding, risk-based control, and documentation needed to demonstrate that a method is fit for purpose and capable of performing consistently over time. If those elements aren’t built in from the outset, gaps are likely...

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Why Chromatography Still Matters in the Age of More Sensitive Mass Spectrometry

Reading Time: 4 minutes

Mass spectrometry (MS) is more powerful than ever. Modern clinical MS systems deliver extraordinary analytical sensitivity, selectivity, and quantitative performance, opening the door to broader test menus with lower detection limits. With capabilities like these, it’s tempting to ask a simple question: Does chromatography still matter as much as it used to? The short answer...

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Advancing Oligonucleotide Purification with MaxPeak Premier OBD Prep Columns

Reading Time: 3 minutes

Oligonucleotide therapeutics continue to grow in complexity, and so do the purification challenges that come with them. Scientists need reliable, scalable solutions for preparative oligonucleotide purification. MaxPeak Premier Oligo OBD Columns provide a powerful solution for these workflows, now expanded to include 19mm ID formats. These columns reduce non-specific adsorption, improve recovery, and enable consistent...

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What’s Really Happening to Your rAAV Under Stress?

Reading Time: 2 minutes

Ensuring the stability of recombinant adeno-associated virus (rAAV) vectors remains a central challenge in gene therapy development. rAAV particles are structurally complex, highly heterogeneous, and sensitive to environmental stress, making it difficult to link analytical changes to functional consequences during manufacturing and storage. A recent Journal of Pharmaceutical Sciencesstudy by Prof. Susumu Uchiyama and colleaguesat...

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Seeing What Others Missed: How CDMS Unlocked Proteasome Function

Reading Time: 2 minutes

Understanding how bacterial proteasomes recognize and process their substrates remains a major challenge in infectious disease biology and drug discovery. In Mycobacterium tuberculosis, this challenge is particularly critical, as the proteasome is essential for bacterial survival inside host macrophages and represents an attractive antibacterial target. A recent Nature Communications study by Prof. Siavash Vahidi and...

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Toward Redosable Gene Therapy: Engineering AAVs to Evade T‑Cells

Reading Time: 2 minutes

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...