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…

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…

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,…

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…

Process Development: One Size Does Not Fit All

      SynCo Bio Partners believe that contract manufacturing should not be “one size fits all†and that the biopharmaceutical contract manufacturing industry needs to explore different collaborative business models in the development of production processes with prospective clients. Most CMOs, including SynCo, offer complete, full process, and analytical method development from the upstream fermentation/cell culture stages to the final purification steps. For small virtual companies to larger organizations with limited available internal resources this can be a good…

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, they have relieved a little of this pressure by outsourcing functions to a limited extent, such as packaging or distribution. Allowing a contract manufacturer to perform some operations frees up companies to focus on their core competencies. Today, however, some of the industry’s most eye-opening success stories are the result of even more extensive…

Launch of Planovaâ„¢ BioEX Virus Filters for Biopharmaceutical Processing

Asahi Kasei Medical Co., Ltd. is pleased to announce the commercial launch of Planova™ BioEX, its new generation of hollow-fiber membrane virus filters. Planova™ BioEX filters are specifically designed to meet the urgent need in downstream biopharmaceutical processing for robust virus filters that not only enhance safety, but also have higher filtration capacities and shorter processing times, even under demanding filtration conditions such as high protein concentration and high filtration pressure. Developed using Asahi Kasei Medical’s unique technology base in…

PAT–Based In–Line Buffer Dilution

Figure 1: Process Analytical Technology (PAT)–based in-line buffer dilution (IBD™) systems produce either binary or ternary blends with tight adaptive control. Up to 100× concentrates are diluted to meet the final dilution end product (1×) specifications. The conductivity of the diluted end product can be controlled to within ±0.1% of the upper limit of the user-defined conductivity range of the detector, and to ±0.1 pH units. Two experiments that were designed and performed to illustrate this blending accuracy are discussed…

Fast and Robust Purification Platform for Influenza Vaccines Production Based on CIM® Monolith Technology

    Figure 1:   Due to potentially very dangerous flu outbreaks in recent years, the need for production of influenza vaccines in sufficient quantities has been expressed. Also, the time needed from vaccine design to the market and overall process efficiency needs to be improved. This, along with drawbacks of the traditional viral vaccine production in embryonated chicken eggs, has led to the use of reverse genetic techniques and cell-culture–based virus propagation. Because existing downstream processes of virus purification…