July 2008

Specialists in Purification and Analysis

Figure 1. As a leading provider of process and analytical solutions for the biotechnology and pharmaceutical industries, Applied Biosystems offers an extensive portfolio of tools to help optimize every stage of biopharmaceutical production — from characterization to purification to pharmaceutical manufacturing. These solutions provide pharmaceutical manufacturers with the tools they require to maximize throughput and yield and ensure product quality. Purification High Performance on a Large Scale: Applied Biosystems POROS Perfusion Chromatography products are today’s best-performing chromatographic media for process-scale…

From Cell Line Optimization to Aseptic Filling

The biopharmaceutical industry is faced with a challenging task: planning, developing, manufacturing, and bringing to market a highly specialized and complex biopharmaceutical product. Competitive pressures, cost, and — above all — time to market are of key concern. The wide range of implementation options, from in-house resources to outsourcing companies of various calibers and capabilities, adds yet another layer of complexity to the decision-making process. Our objective is to offer our customers a full-service alternative to the development and manufacturing…

Flexible, Cooperative, Midsized Miltenyi Biotec, a CMO for Biopharmaceuticals

Trust, competence, and motivation are the major characteristics of a reliable contract manufacturer for clinical projects. At Miltenyi Biotec, customers have more than just projects: they have goals that Miltenyi Biotec helps them to achieve. Miltenyi Biotec is a midsized biotechnology company, focused on medical devices, equipment, and therapeutics for R&D and clinical applications. The product expertise includes GMP-grade antibodies, peptides, growth factors, cytokines, aphaeresis materials, and cellular products, resulting in a broad and significant understanding of different manufacturing challenges.…

Protein Projects Integrated Development

Founded in 2000 in Grenoble, France, Protein’eXpert is an expanding contract research organization devoted to recombinant protein engineering and production. Our 50-member staff offers custom-designed services focusing on the discovery, optimization, and production of valuable target or therapeutic proteins. Since 2004, Protein’eXpert has extended its offering to the biomanufacturing of therapeutic protein and recombinant vaccines for early clinical trials through its integrated subsidiary PX’Pharma. PX’Pharma provides dedicated contract services for process development and scale-up optimization as well as preclinical and…

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 350. 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, 250 L, 500…

Outsourcing Clinical Manufacture

The biopharmaceutical industry is a predominantly research-based industry that is rapidly maturing toward commercialization. As it does so, biopharma executives have to grapple with complex issues concerning process development, scale-up, and preclinical manufacture of material for toxicology studies, clinical studies, and eventually commercial sale. Selecting a suitable CMO, negotiating a robust contract, and managing on-going relations are of utmost importance to successfully securing a timely, quality supply of product. There are very different types of CMO. Some CMOs are biopharma…

Taking the Next Step with Contract Manufacturers

Pressure is bearing down on all sides. Pharmaceutical and biotechnology companies face stress from increasing costs, intensifying global competition, growing regulatory stringency, and more. For years, pharmaceutical and biotechnology companies have relieved a little of that pressure by outsourcing functions to a limited extent, such as in packaging or distribution. Allowing a contract manufacturer to perform some of these operations frees up companies to focus on their core competencies. Today, however, some of the industry’s most eye-opening success stories are…

Scale Up on Efficiency in Biologics Contract Manufacturing

Wacker Biotech has a 20-year track record in manufacturing microbial-derived biopharmaceuticals, giving us a deep understanding of such products and of our customers’ needs. We provide comprehensive contract-manufacturing services and proprietary technologies that significantly lower the cost of goods. Our customers benefit from a comprehensive service for the development of robust, highly efficient, and readily scalable processes and GMP-compliant manufacturing for clinical trials and commercial supply. Service We work in close collaboration with our customers. Projects are managed by dedicated…

DAISOGEL C4-Modified Phases for Protein Purification

Figure 1. Recently, purification of biomolecules, such as peptides and proteins, by process scale HPLC using reversed phase silica gel media has become increasingly important in biopharmaceutical production. DAISOGEL SP-300-C4-BIO is the newest product using this technology, a butylsilyl(C4)-modified silica gel with 30-nm pore diameter for applications involving peptides, proteins, and other large molecules. Besides selectivity, several other aspects influence the performance of chromatography in preparative processes and consequently have a crucial effect on the total process cost. Therefore, when…

Developing Scalable, Robust Processes That Result in Stable, Active Products

KBI Biopharma is a leading contract development organization for the biopharmaceutical industry. We accelerate and optimize drug development and manufacturing programs for our client partners, including global pharmaceutical and biotechnology companies and organizations in biodefense. Our clients benefit from faster time to market and lower cost of manufactured goods. Ongoing Innovation We are continually working on new technologies and new partnership opportunities to enhance biomanufacturing. Our expertise in biophysical and biochemical protein characterization makes us highly successful in delivering optimal…