July 2009

Supporting Biopharmaceutical Visions

      ProBioGen AG is a specialist for mammalian and nonmammalian high-producer cell engineering and GMP manufacturing of biopharmaceuticals. Combining a deep molecular understanding of cells, scientific expertise, state-of-the art industry process engineering, and production know-how, ProBioGen is the partner of choice for biopharmaceutical companies seeking outstanding cell line development and manufacturing capabilities. Moreover, the company’s proprietary AGE1.cell lines® are licensed to several key players in the industry and enable cost-efficient and safe production of vaccines and proteins. ProBioGen…

A New Solution for Endotoxin Removal in Biomanufacturing Processes

EndoTrap HD® manufactured by Hyglos GmbH (former Profos AG) is a new revolutionary tool especially designed to meet the needs of pharma and biotech industry for the efficient removal of endotoxins in biomanufacturing processes. EndoTrap® HD fulfils all requirements for industrial applications, and it can easily be integrated in/at early or late-stage purification processes of biological substances such as proteins, drugs, antibodies, or vaccines. Background Endotoxins (lipopolysaccharides, LPS) are major contaminants found in commercially available proteins or biologically active substances.…

Comparability Between the Mobius® CellReady 3-L Bioreactor and 3-L Glass Bioreactors

Figure 1: The Mobius CellReady 3-L bioreactor is a single-use, stirred-tank bioreactor ideal for bench-scale cell culture. The CellReady 3-L bioreactor is preassembled and gamma irradiated, significantly reducing turnaround times typically associated with glass bioreactors. There is no need to clean, assemble, or autoclave between experiments. The CellReady 3-L bioreactor ensures maximum operational flexibility with prefitted, weldable tubing and vent filter; two sparging options; and compatibility with most standard bioreactor controller configurations. Designed to replace traditional glass, bench-scale bioreactors, the…

Improving Peptide Mapping

Figure 1: Peptide mapping is the workhorse technique in biopharmaceutical analysis, offering the comprehensive characterization of biopharmaceutical products. Its applications include the identification of proteins based on the elution pattern of peptide fragments, the determination of posttranslational modifications, the confirmation of genetic stability, and the analysis of protein sequences when interfaced to a mass spectrometer. In a typical peptide mapping workflow, a protein is first digested with trypsin or other protease to generate peptides, which are separated by liquid chromatography,…

A Team of Experts

  Who We Are     Based in Grenoble, France, PX’Therapeutics (formerly known as Protein’eXpert) is a contract research and manufacturing organization devoted to the development of biotherapeutics. Our 50-person staff offers custom-designed services ranging from recombinant protein and monoclonal antibody discovery and optimization up to clinical cGMP manufacturing for preclinical and clinical studies.   Acknowledged Scientific Expertise   We have demonstrated our high level of expertise in protein science and our capability to tackle complex and recalcitrant projects. We…

Viresolve® Pro and Pro+ Solutions: Next-Generation Parvovirus Safety

Figure 1: Millipore Corporation’s new Viresolve Pro and Pro+ solutions are a major leap forward in virus clearance technology. As biotech manufacturers experience high titers, the evolution of process platforms and increasing focus on cost of goods, the demand for a robust high-capacity unit operation is increasing. Viresolve Pro and Pro+ solutions deliver robust parvovirus clearance, high productivity, and performance assurance. The Viresolve Pro and Pro+ solutions offer the highest level of virus clearance for the development of biopharmaceutical products.…

From General Data Management to Advanced Audit Trails…

Figure 1: New Brunswick Scientific has developed three new versions of Supervisory Control and Data Acquisition (SCADA) software programs. These SCADA programs allow fermentation or cell culture processes to be automated, monitored, and controlled. The three packages — BioCommand® Track and Trend, BioCommand Batch Control, and BioCommand Batch Control Plus — provide a variety of tools and the flexibility needed for any process requirement. Whether you require only basic trending and batch reporting, programming for process automation and optimization, or…

A One-Stop, Full-Service Provider

Recipharm Biologics is part of Recipharm AB of Sweden, one of Europe’s leading contract development and manufacturing organizations. Privately owned and financially robust, Recipharm specializes in providing customers with a full-service, one-stop-shop approach — from formulation and analytical development through to commercial manufacturing. We employ some 1,400 people and have been operating since 1995. With manufacturing facilities located in Sweden, France, the United Kingdom, and Switzerland, we can handle a wide range of dosage forms including solid dose, sterile (liquids…

ChromaSorb™ Single-Use Membrane-Based Anion Exchanger

    Figure 1:   Millipore Corporation’s new ChromaSorb membrane adsorber uses an innovative membrane-based anion exchanger to perform robust impurity clearance at a wide range of salt concentrations. This feature enables users to improve their process economics by eliminating the downstream bottleneck of buffer tank capacity inherent with the use of other membrane adsorbers, as well as traditional resin chromatography. ChromaSorb membrane adsorber provides enhanced process flexibility and efficiency and a smaller manufacturing footprint than traditional anion resins and…

albufuse®: Extended Circulatory Half-Life and Bioavailability of Biological Drugs with Albumin Fusion Technology

Figure 1: Biological drugs are an increasingly important and growing part of the pharmaceutical industry but are associated with a number of challenges that have constrained their application. The lack of efficacy due to short protein half-life and/or poor availability is an issue that leads to a requirement for both high and frequent dosing (Figure 1). Such administration demands can result in unwanted side effects and limit the therapeutic benefits, as well as elevated patient dosing that creates an extra…