Industry Yearbook 2015-2016

New Host-Cell Protein Assay for Escherichia coli Cell Lines

With the E.coli|360-HCP assay, a second host-cell protein (HCP) assay based on the novel 360-HCP ELISA concept enters the market. 360-HCP ELISA integrates four different assay types. So a scientist can evaluate in no time which kit type performs best for a specific process. Read the full text of this application note in the PDF (Login required).

Optimize and Monitor Product Integrity

Development of a single drug, whether it is a new chemical entity, biotherapeutic, or genetic/cellular therapy, requires significant investment of resources. Care must be taken to choose analytical methods that are fit for the purpose of monitoring product and contaminants in the process. With expertise in labeling and detection, Enzo offers solutions to help rapidly analyze protein stability and integrity for all your bioprocessing needs. Read the full text of this application note in the PDF (Login required).

Data-Driven Decisions to Maximize Productivity Using Automated Immunoassays in Clone and Bioprocess Development

High productivity in bioprocess development demands efficient bioanalytical procedures to measure clone expression, product titer, and process impurities. Commonly used methods such as enzyme-linked immunosorbent assay (ELISA) or high-performance liquid chromatography (HPLC) can create bottlenecks in critical workflows due to limitations in throughput, performance, and time to results. Read the full text of this application note in the PDF (Login required).

Generation of High-Performing CHO Cell Lines for GMP Biomanufacturing

Since the approval of tPA derived from Chinese hamster ovary (CHO) cells in 1986, stable expression of recombinant proteins has become a very important system for the manufacture of therapeutic proteins. With an increasing number of therapeutic proteins in development, the demand for fast and robust development of manufacturing cell lines is still increasing. During the past 30 years, the productivity of stable recombinant cell lines could be increased from <100 mg/L to several g/L. The huge increase in productivity…

Nova Biomedical

Nova Biomedical is a technology company based in Waltham, MA, that provides state-of-the-art, automated cell-culture analyzers for the biopharmaceutical market. In 1998, Nova introduced the first line of chemistry analyzers for the biotechnology industry: the BioProfile® series. Nearly a decade later, Nova added the BioProfile Flex series featuring an expanded menu and real-time analysis of key metabolites, nutrients, and gases in cell culture media. In 2011, we announced the BioProfile CDV automated cell density/viability analyzer, which measures up to 80…

Performing Three Key Microbiology Quality Control Tests with a Single, Automated Instrument

Microbial quality control (QC) testing is a critical aspect of pharmaceutical, medical device, and personal‑care products manufacturing. Such tests typically include the following: environmental monitoring (analyzing the air, surfaces, and personnel within cleanrooms to ensure manufacturing areas meet mandated standards) bioburden testing (testing devices, components, raw materials, or finished goods to verify that the total population of viable organisms is within acceptable limits) sterility testing (testing final or in‑process products for viable organisms; a sterility test result should show no…