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Inspecting AI is not new to regulators. The expectations are already well-established. The key question is whether your organization can reliably demonstrate them. Written by Tracy Hibbs and Tony Sacchetti, Waters Corporation Exploring artificial intelligence (AI) and machine learning (ML) in regulated laboratories governed by Current Good Manufacturing Practices (CGMP) may be new for your…
Why 2026 marks the shift from guidance to enforcement and what it means for your organization now. Written by Tracy Hibbs and Tony Sacchetti, Waters Corporation Regulators are already inspecting AI use, how prepared is your organization? For years, the pharmaceutical industry has anticipated regulatory clarity on the use of artificial intelligence (AI) and machine…
Stage 3 verification: Establishing and maintaining a state of control In pharmaceutical quality control (QC), consistency should mean more than an analyst ending a shift relieved that the results were repeatable and there were no obvious failures. It should mean having enough confidence in the process, the controls, and the data to know that those…
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…
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…
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…
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…
In drug manufacturing, there is no room for error. Every decision, from early formulation to final release, must ensure a product is safe, effective, and consistent. At the center of this process are critical quality attributes (CQAs), the measurable properties that define whether a drug meets its required standards. In this blog, we break down…
In hospital intensive care units, insulin is a critical therapeutic used to maintain tight glycemic control. While it is typically supplied at 100 units/mL, clinical protocols dilute it to 1 unit/mL for continuous infusion, commonly known as the insulin infusion protocol (IIP). At these low concentrations, ensuring stability becomes challenging, especially when aggregation or surface…
Biologics developers today face unprecedented pressure: tighter timelines, increasingly complex antibody formats, and a growing need for real-time process understanding. Yet many analytical workflows still rely on methods that can’t deliver the speed, sensitivity, or depth required for modern bioprocessing. That’s where advances in Protein A (ProA) affinity chromatography are making a meaningful difference, reshaping…
The Role of Enzymes in LC-MS Analysis of Modern Biotherapeutics Enzymes are nature’s catalysts, enabling precise and efficient biochemical transformations. In analytical workflows, enzymatic digestion is a cornerstone technique for breaking down complex biomolecules into smaller, more manageable fragments. This process is critical for applications such as peptide mapping in protein characterization and oligonucleotide mapping…
The FDA’s October 29, 2025 draft guidance has generated significant attention due to the implications for both developers and patients. By allowing developers to bypass comparative efficacy studies (CES) when advanced analytics are successful substitutes, the draft guidance avoids one of the most expensive steps, estimated to account for 70% of the total biosimilar development…