Interferon beta-1b is a protein in the interferon family used to treat the relapsing-remitting form of multiple sclerosis (MS). Interferon beta-1b is a natural human protein (molecular weight ~18,500 Da) that is produced in the body in response to viral infection and has antiviral activity. It has been shown to slow the advance of MS and reduce the frequency of attacks. It is believed that interferon-beta achieves this effect on MS progress via its anti-inflammatory…

          The use of 0.1-µm rated sterilizing grade filters has been increasing in cell culture media filtration due to mycoplasma contamination concerns. Currently, no standards exist for conducting mycoplasma retention testing on these 0.1-µm labeled filters. A task force has been established at PDA to publish a technical report to standardize testing. Until such guidelines are published, conducting side-by-side tests under identical conditions is the only fair way to compare different 0.1-µm rated filters. Sartorius Stedim…

          Major drivers in biopharmaceutical development and manufacturing include improved performance in bioprocess cell culture through increased cell viability, product quality, and yield. Success has been achieved in addressing these drivers using Thermo Scientific HyClone Cell Boost by providing solutions that include strategic supplementation of nutrients based on metabolic profiling of cells and media at various stages of the bioprocessing cell culture campaign. One of the greatest improvements is derived from increased viable cell concentration and…

          Whether evaluating conventional stainless steel or single-use bioreactors, every system must accomplish the same thing: control a bioprocess for an intended result. The result may be biomass, product titer, substrate conversion, or any number of complex, process-specific productivity measures. Each system shares the same basic elements, including a bioreactor vessel and a gas addition subsystem. The vessel uses an agitation subassembly, gas sparger, and in some cases, gas overlay elements. These must be properly engineered…

          IDBS provides a flexible data management solution that meets the diverse demands of biologic drug development based on our extensive experience working with global biopharmaceutical and contract manufacturing organizations. the IDBS Bioprocess data Management solution enables streamlined execution of process workflows, improved data access, sharing and reporting, and the process insight needed to successfully reduce the time and cost required to deliver new biologics to market.   Managing Diverse Data   Biopharmaceutical companies generate a…

          As the pharmaceutical industry focuses on developing biological drugs derived using cell culture processes, the ability to optimize the growth, health, and potential yield of the cell line becomes increasingly important. Finding the optimal cell culture media is a daunting and time-consuming process due to the amount of potential media components and the unique requirements of the cell line being researched. Osmolality information is a crucial component to this research because of its close relationship…

          Bioengineering AG has been planning and constructing biotechnological plants for over 35 years. Holistic solutions have become the status quo: from inoculation to harvest, from feed line to CIP-system, and from automation to validation. The know-how acquired over years should not be limited to customers fermenting with Bioengineering equipment. Therefore all Bioengineering components are available as single parts. These custom-made components for a variety of special applications facilitate progress in culture technology.   Operational Safety…

          The bacterial endotoxins test (BET) is unique because of its biases. Several biases in the BET are caused by the variability of standard endotoxin dilutions and the methodologies of the Limulus amebocyte lysate (LAL) test. The purpose of this study is to clarify those biases.   Bias from the Standard Endotoxin Dilutions   Operators for the BET often encounter variability of the potency in the standard endotoxin dilutions. To clarify the practical variability of the…

          Monitoring for contaminants is a critical step during the production process in the pharmaceutical and medical device industries. Endotoxin, a frequent contaminant, can cause fever, inflammation, headache, nausea, and even death. Found in the cell walls of gram-negative bacteria, endotoxin has routinely been detected by the sensitive and specific Limulus amebocyte lysate (LAL) assay. In the presence of endotoxins, LAL coagulates through an enzyme-mediated cascade, which has then been traditionally quantified based on gelation and…

          As production facilities strive for greater efficiency, a common practice is to seek process improvements in quality control (QC) operations. All production facilities share some common requirements for these QC checks, especially that they can be fast, simple, proven, and economical. In addition to this, the production of biological materials such as proteins frequently presents additional requirements, including the need to perform QC tests using very small volumes and the ability to measure the protein…