Analytical Tools for Developing Biosimilars: Part 2, Peptide Analysis
Advancements in High-Resolution Analytics for Characterization of Innovator and Biosimilar Therapeutics Part 2: Peptide Analysis of Infliximab
How Analytical Technologies Support the Development of Biosimilar Drugs
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
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
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
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
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…
Three Reasons for Biopharmaceutical Labs to Add Mass Detection to Routine Analyses
As regulators focus in on the critical quality attributes of biotherapeutics, what can biopharmaceutical labs in late development or QC do to increase confidence in their bioseparations – other than to run more assays?
When Consumables Kits are Greater Than the Sum of their Parts
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…
The Answer to Fast, Sensitive, and Simple Released N-Glycan Profiling and Characterization
How quickly can you go from glycosylated protein to glycan fragment confirmation? Now, analyzing released N-glycans takes about as much time as it does for Tom Brady and the New England Patriots to erase a 10-point deficit and win a football game. An exaggeration? Perhaps, but with the help of the new Waters GlycoWorks…
Waters and Ferring Collaborate to Host Peptide Bioanalysis Forum
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
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…
Killing the cancer while keeping the patient healthy: ADCs
One of the opportunities for personalized medicine is that by targeting a disease, can you eliminate the side effects of the cure? Antibody drug conjugates (ADCs) are one next-generation therapeutic approach that may have an answer. As the Cleveland Clinic notes, “Chemotherapy, the only form of treatment available for treating some cancers, destroys cancer cells…