July 2009

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…

ZAP-CHO: A Powerful New CHO Cell Culture Supplement

Figure 1: ZAP-CHO enhances performance of mammalian cell culture by optimizing cell growth and reducing apoptosis, leading to higher antibody production yield. It achieves these performance advantages in commercial media, especially chemically defined media and serum– or animal-component–free media. Because ZAP-CHO is defined and free of animal components, it is an ideal additive for cell culture media formulations. ZAP-CHO is an important breakthrough in mammalian cell culture operations. Previously, the performance seen with ZAP-CHO required the use of hydrolysates, FBS…

Unique Competence in Biopharmaceuticals

      Rentschler Biotechnologie GmbH is a full-service contract manufacturer with over 30 years of experience in the development, production, and approval of biopharmaceuticals in compliance with international GMP standards with a highly skilled staff of 450. As part of the Rentschler Group and headquartered in Laupheim, Germany, Rentschler is one of three leading European CMOs operating globally. Dedicated to delivering high-quality biopharmaceuticals produced in mammalian cell culture, Rentschler has nine stand-alone GMP suites with volumes of 30 L,…

Novel Improvements to Sanitary Flange Adapters and Fluid Sampling Sites for Single-Use Systems

    Figure 1:   SterilEnz®-II/G connectors and SterilEnz Samplers represent a novel design improvement when compared with common fittings and fluid injection sites. This article briefly discusses the features, benefits, and technical aspects surrounding the design and integrity testing of the SterilEnz product line as well as advantages over their predecessors.   SterilEnz-II/G Flange Connectors and Samplers   Each SterilEnz-II/G connector is hermetically sealed inside a rugged overwrap pouch (Figure 1). The connector is fitted with a pre-attached, medical…

Process Analytical Technology (PAT) in Powder Media Production

Quality control is very often perceived as the last step in manufacturing a product. But quality is not a consequence of quality testing; it must be built into the manufacturing process. At the beginning of the 21st century, the FDA Advisory Committee for Pharmaceutical Science (ACPS) began to address this problem, calling for consistent regulations in designing, analyzing, and controlling pharmaceutical manufacturing processes. As a result, process analytical technology (PAT) was developed providing a framework for innovative pharmaceutical manufacturing and…