2010

Nonmetallic Fluid Handling Components and Systems

          BioConnexx specializes in engineering, manufacturing, and distributing reusable and single-use fluid handling components and systems for the biotechnology and pharmaceutical fields. BioConnexx products are designed and manufactured to meet or exceed all standing guidelines and regulations with stringent material selection and carefully considered design. With years of intense and thorough research and engineering, BioConnexx has assembled a complete line of “off-the-shelf” and custom products manufactured under specific guidelines and engineering tolerances and tailored to meet…

The Culture of High-Tech Components

          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…

Comprehensive Global Capabilities and Extensive Scientific Expertise

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its comprehensive portfolio of services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today. Working with clients of all sizes, Covance recognizes that your development program is as unique as the product you bring to our facilities. With over 250 different biomolecules successfully supported annually, Covance Biopharmaceutical Services provide…

New Protein G Biosensor Brings “Out-of-the-Box” Detection of Diverse Mammalian Antibodies

Today’s antibodies are sourced from a diverse set of mammalian hosts whose isotypes have different affinities for protein A and protein G. ForteBio’s new protein G biosensor provides an “out-of-the-box” solution for direct quantitation of the mammalian immunoglobulins that do not bind to protein A. Readings can be performed in buffer, chromatography eluents, conditioned medium, and cultured lysates using a convenient 96- or 384- well microplate format. Assay parameters can be adjusted to detect concentrations from 0.05 µg/ml to 2,000…

Biopharmaceutical Product Development

Catalent Pharma Solutions offers a total solution for the development and manufacture of biopharmaceutical and sterile products. Our proprietary technology — and expertise in working with proteins, peptides, and other biotechnology-derived active materials and small molecules — helps to maximize the potential of your API and accelerate your product’s speed to market. From cell line engineering to manufacture of API and drug product for clinical trials, our team of highly experienced protein chemists, biochemists, pharmacists, and pharmaceutical scientists provide the…

Biases in the Bacterial Endotoxin Test

          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…

BioManufacturing Network

          Diosynth Biotechnology, based in Research Triangle Park, NC (USA) and MSD Biologics (formerly Avecia Biologics) based in Billingham, UK have combined to form the BioManufacturing Network. Together the two organizations offer industry-leading CGMP contract manufacturing services for recombinant proteins, vaccines, and monoclonal antibodies with an attractive geographical footprint in the USA and Europe. Our combined expertise enables our customers to improve the cost-effectiveness of new therapies by providing fast-track progress into and through their clinical…

Ready-to-Use Solutions Speed Up MAb Bioprocessing

  Summary   Comparison of a complete MAb purification process from a 100-L cell culture volume demonstrated a 50% reduction in process time using the ReadyToProcess platform instead of traditional process equipment. The decrease was made possible by elimination of column packing and testing, membrane wetting and rinsing, system cleaning, cleaning validation, and so on. Additionally, the ReadyToProcess run required less hardware and thus generated a smaller footprint. Both chromatography steps were run on one system using disposable, exchangeable flow…

How to Balance High-Titer Processes with Consistent Quality?

          The high cell culture process (XD®) is a continuous process in which both cells and product are retained in a stirred-tank bioreactor using suspension mammalian culture. This is accomplished using a retention system: Fresh medium is continuously supplied, and metabolic byproducts are withdrawn and discarded through the retention system. XD® provides a controlled environment that leads to consistent product quality in terms of bioactivity, glycosylation pattern, and other product characteristics. Moreover, XD® technology is independent…

Microplate-Based Endotoxin Testing in GLP/GMP Environments

          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…