We help ensure the medicines people take every day are reliably safe and effective, from the common aspirin to the most complex biotherapy. Tests performed using our liquid chromatography-mass spectrometry (LC-MS) instruments ensure the efficacy and safety of these complex, protein-based drugs well before they reach the patient.
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…
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The FDA’s October 29, 2025 draft guidance has generated significant attention due to the implications for both developers and patients.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developers to bypass comparative efficacy studies (CES) when advanced analytics are successful substitutes, the draft guidance avoids one of the most expensive steps, estimated to account for 70% of the total biosimilar development…
Whether you are analyzing adeno-associated viruses (AAVs) or virus-like particles, nucleic acids such as RNAs or lipid nanoparticles (LNPs), proteins, or protein complexes, simple and fit-for-purpose tools with speed, accuracy, and precision are essential for driving biotherapeutic innovations forward. In recent years, scientists have increasingly turned to charge detection mass spectrometry (CDMS).
In the realm of cutting-edge medical treatments, cell therapy products have emerged as revolutionary tools in combating a myriad of diseases, ranging from cancer to genetic disorders. These therapies harness the power of living cells to regenerate damaged tissue, modulate immune responses, or directly target malignant cells. However, amidst the promise of these novel treatments…
Glass delamination has been a persistent challenge in the pharmaceutical industry, posing risks to drug stability and patient safety. The phenomenon occurs when shiny, thin glass layers (lamellae) detach from the interior surface of a glass container and float in the contact liquid. These subvisible glass particles (SVGPs) can cause serious health risks, including infusion-related complications….
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…
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…
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…
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….
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…