Analytical Methods and Instrumentation

Improving Efficiency and Throughput for Titer and Impurity Bioanalytics: Using an Automated, Nanoliter-Scale Immunoassay Platform

Increasing efficiency and productivity for titer and impurity bioanalytics is even more critical as a result of increasing workloads in supporting multiple programs with limited resources. Current methods such as enzyme-linked immunosorbent assay (ELISA) or high-performance liquid chromatography (HPLC) create bottlenecks in critical workflows because of throughput constraints, repeat testing, or longer assay times. The Gyrolab™ workstation is an automated immunoassay platform that can generate high-quality analytical data at high throughput using nanoliter volumes for more rapid and efficient titer…

Biopharmaceutical Product Development: Helping to Develop Better Biologic Products, Faster

From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. With over 80 years of experience, we have the deepest expertise, broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and improved results. Catalent is your strategic partner for biologic drug development success. SMARTag™ ADC Technology for the Development of Optimized Antibody–Drug Conjugates: Catalent has an…

Automated Rapid Microbial Methods: Taking Environmental Monitoring Testing Out of the QC Labs

Environmental monitoring of clean rooms is an integral part of a pharmaceutical company’s quality control testing program. Analyzing the air, surface, and personnel within cleanrooms helps ensure the manufacturing environment meets mandated standards and that any variations can be addressed. Unfortunately, the traditional method for environmental monitoring is manual, inefficient, and time consuming. Laboratory technicians must travel, sometimes across large campuses, to collect samples in manufacturing suites. Technicians have to gown, take the samples, and travel back across the campus…

Bacterial Endotoxin Testing: New Method for Unmasking Endotoxin in Biopharmaceuticals

  Following the initial observations by Chen et al., leading manufacturers of biopharmaceuticals have determined that endotoxin (LPS) can be “masked” in biopharmaceutical formulations typically containing phosphate, polysorbate, and sugars (1). Being in a masked state, endotoxin is undetectable by the commonly used factor C detection methods such as the Limulus amebocyte lysate test (LAL). This phenomenon has also been denominated low endotoxin recovery (LER). As previously shown by Reich et al. (2), endotoxin masking is time dependent, meaning that…