biopharmaceutical

  • Analytical Tools for Developing Biosimilars: Part 3, Glycosylation, Aggregation, and Charge Variants

    By Scott Berger Reading Time: 8 minutes

    In biotherapeutics, the state of glycosylation has a direct and pronounced effect of the structure, stability, serum half-life, immunogeneicity and bioactivity of the molecule, and constitutes a critical quality attribute (CQA). In our study, characterizing and comparing the glycosylation profile of infliximab began by examining the glycosylation profiles from intact and reduced subunit mass data.

  • How Analytical Technologies Support the Development of Biosimilar Drugs

    By Scott Berger Reading Time: 10 minutes

    Advancements in High-Resolution Analytics for the Characterization of Innovator and Biosimilar Therapeutics As the pharmaceutical industry continues to evolve its focus from small-molecule drugs to balanced product portfolios that include protein therapeutics, analytical chemists are increasingly challenged to produce routine and automated characterization workflows that move innovator and biosimilar biopharmaceutical products forward through development and…

  • Oligonucleotide Therapeutics on the Rise… Again

    By Joe Fredette Reading Time: 4 minutes

    Oligonucleotide drug development has seen its share of ups and downs over the past 20 years – but why? The promise of antisense oligonucleotides (ASOs) and later small interfering oligonucleotides (siRNAs) as therapeutics that can “dial down” or even “turn off” the expression of specific genes/proteins (“gene silencing”) remains high, yet companies dedicated to their…

  • Tandem Quad Mass Spectrometry: The Foundation of Product Safety, Efficacy, and Decision-making

    By Waters Staff Reading Time: 2 minutes

    There is a rightfully high expectation from consumers that the amounts of compounds and ingredients that producers report in their goods are accurate down to trace levels.  Whether personally or professionally, we all rely on this analytical information coming from laboratories that enables critical decisions to be made. Analytical chemists have been performing quantitative studies…

  • Mass detection and mAb QC: How a cost-effective and robust peptide mapping method confirms CDR peptides – and can be validated

    By Brian Murphy Reading Time: 3 minutes

    The quality issues of biopharmaceutical therapeutics are definitely different from chemical drugs because of the increased complexity of manufacturing processes and complexity of the biologic molecules themselves. There is an increasing need for detailed product characterization and control of the manufacturing process. Sheng Hou et.al. have developed and validated a practical, cost efficient, robust adalimumab…

  • A View of the Biopharmaceutical Industry in Asia — an Interview with Ken Fountain

    By Brian Murphy Reading Time: 5 minutes

    Ken Fountain, Director of Biopharmaceutical Business Development at Waters, recently returned from an insightful trip to Asia where he visited Waters customers in South Korea and attended the China Biopharma Executive Summit in Shanghai, in which Waters was a sponsor. We caught up with him and asked him to share his thoughts about the biopharmaceutical…

  • When Consumables Kits are Greater Than the Sum of their Parts

    By Brian Murphy Reading Time: 4 minutes

    ProteinWorks and GlycoWorks kits address more than sample prep challenges One of the most challenging parts of an LC-MS workflow happens before analytical chemists even turn to their instrument: Sample preparation. Get it right, and the analytical run performs as expected. Get it wrong, and the assay has any number of problems, from poor sensitivity…

  • Waters and Ferring Collaborate to Host Peptide Bioanalysis Forum

    By Waters Staff Reading Time: 3 minutes

    Close to sixty scientists from across Western Europe gathered for the Peptide Bioanalysis Forum held on-site at Ferring Pharmaceuticals A/S in Copenhagen on February 3-4, 2015. A collaborative effort between Ferring Pharmaceuticals and Waters Corporation, the proceedings kicked off with introductions by the organizers, Dr. Magnus Knutsson, Director of LC-MS/MS Bioanalysis at Ferring, and Dr….

  • Now Available: Peptide and Protein Bioanalysis Application Notebook

    By Waters Staff Reading Time: 2 minutes

    Peptides and proteins are not small molecules. Why treat them the same? Analyzing large molecules may be one of the greatest challenges that the bioanalyst faces at the beginning of the 21st century. Employing LC-MS for the bioanalysis of large molecules requires the extraction of the target analyte from a matrix of biochemically similar peptides and proteins. However, we have…