July 2009

Designing, Developing, and Delivering Our Clients’ Biopharmaceuticals

      Eden Biodesign is a globally integrated biopharmaceutical and vaccine contract biomanufacturing company. We are an expert provider of consultancy, biopharmaceutical process development, and CGMP manufacturing services. Our rarely found blend of experience and expertise, gained from providing services to a worldwide client base, ensures that the clinical medicines we develop are regulatory compliant and optimally positioned for further clinical and commercial development. Our state-of-the-art facility in Liverpool, UK, is licensed to produce clinical products, which is best…

Characterization-Based Manufacturing Process Development of Protein Therapeutics

      KBI Biopharma is a leading contract development and manufacturing 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 employing new technologies for the analysis of proteins and developing new partnerships, technologies, and services to enhance biomanufacturing. Our…

Analytical Strategies for Monitoring Residual Impurities Encountered in Bioprocessing

    Profiling of impurities in biopharmaceuticals and their associated intermediates and excipients is a regulatory expectation. Since residuals are typically present at low levels in difficult sample matrices, development and validation of assays can be quite challenging (Figure 1). Matrix types can vary greatly due to the fact that sampling at a variety of process steps is required to accurately monitor throughout the production process. Figure 1: ()   Some residual impurities are introduced in the upstream steps as…

Developing Fusion Proteins for Therapeutics

Fusion proteins are generating a lot of excitement these days because of their targeted use in therapeutic treatments of cancer, autoimmune diseases, and metabolic diseases. The webcast “Recent Trends In The Development and Manufacturing of Fusion Proteins As Therapeutics” examines the practical applications of fusion proteins and the challenges that manufacturers face. Created by joining two or more genes originally coded for separate proteins or protein domains, a fusion protein results in a single polypeptide that includes functional properties from…

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 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…

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…

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…

Sandoz: A Provider of Customized Solutions in Biotech Manufacturing

      Sandoz is one of the leading specialists in microbial fermentation of classic and recombinant microorganisms. The company’s comprehensive know-how is based on more than six decades of experience in the field of classical microbial products and more than two decades in recombinant microbial production at commercial scale. Building on this know-how, Sandoz offers a broad variety of integrated services including innovative expression systems, process development, scale up and production of recombinant products derived from microbial systems, and…

Getting to Clinical Trials Faster with a Better Formulation: Symyx CDMO

      Symyx CDMO (contract development and manufacturing organization) provides a faster, more reliable route to clinical trials by delivering drug product manufactured with a highly optimized and robust formulation. We have over a decade of experience working with the smallest biotechnology start-ups and the largest pharmaceutical companies. Symyx combines formulation expertise, high-productivity research technology, and CGMP manufacturing capability in a single facility.   Biopharmaceutical Development and CGMP Manufacturing   Symyx has the subject-matter expertise and technologies to integrate…