2010

New Therapeutics Through Fermentation Technology

          Applications of microbial fermentation technology in new therapeutics are expanding. SAFC offers unique cGMP fermentation-based manufacturing capabilities through its Jerusalem facility, including highly potent APIs and biologics. SAFC scientific teams provide a complete range of services, including process evaluation and development, optimization and scale up, technology transfer, manufacturing, analytical testing and regulatory filing to help customers bring new drugs to market faster. SAFC is finding new applications for its expertise in fermentation technology, including the…

An Improved Performance Affinity Adsorbent

          Albumin and albumin-related proteins such as albumin fusion proteins represent an increasingly important platform for production of therapeutic proteins with extended in vivo half-lives. Affinity ligands directed to the albumin portion of the molecule are ideally suited to development of a purification platform for albumin containing proteins. In addition, significant reductions in manufacturing costs are possible, especially if processing times can be shortened through use of higher flow rates.   Introduction   Mimetic Blue® SA…

Single-Use Bioreactors with Unparalleled Mixing, Scalability, and Ease of Use

        PBS 3-L benchtop bioreactor ()   PBS Biotech has emerged into the growing single-use bioprocessing space with an offering truly unlike any other: elegant, powerful, and incredibly easy-to-use bioreactors. A commitment to quality and innovation is evident in every design element of PBS Biotech’s Pneumatic Bioreactor System™. The proprietary Air-Wheel™ agitation mechanism powered by gas buoyancy provides unparalleled mixing performance for cell cultivation. The result is rapid liquid mixing, efficient mass transfer, and significantly lower shear…

AAIPharma Services Corp.

          For more than 30 years, AAIPharma Services has provided drug product development services to pharmaceutical, biotechnology, and medical device companies around the world. Our team of 400+pharmaceutical scientists and professionals, including 20 PhDs, pride themselves on providing solutions to the most difficult drug development and manufacturing challenges. We have developed drugs in all major therapeutic areas, have had our work included in over 500 INDs, and currently provide services in support of more than 50…

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…

Automated Parallel Chromatography in Downstream Process Development

          The demand for biopharmaceutical products, in particular, monoclonal antibodies (MAbs), is rapidly increasing during recent years. The necessity for pharmaceutical companies of being first to market combined with the need to cut development costs makes the application for high-throughput screening (HTS) techniques and tools in downstream process development indispensable. Atoll’s 96 MediaScout® RoboColumn® array together with Tecan’s Freedom EVO® liquid handling workstation enables fully automated parallel column chromatography for the first time. The RoboColumn® design…

Human Interferon Beta-1b Production in Pseudomonas fluorescens

          Interferon beta-1b is a protein in the interferon family used to treat the relapsing-remitting form of multiple sclerosis (MS). Interferon beta-1b is a natural human protein (molecular weight ~18,500 Da) that is produced in the body in response to viral infection and has antiviral activity. It has been shown to slow the advance of MS and reduce the frequency of attacks. It is believed that interferon-beta achieves this effect on MS progress via its anti-inflammatory…

Althea Technologies, Inc.

          Althea is a contract developer and manufacturer of biopharmaceutical and injectable products, with fully integrated product development and cGMP manufacturing expertise to support client projects from preclinical development through commercial supply. Each project program at Althea is tailored to the specific needs of your product, allowing you to leverage our entire integrated manufacturing approach, or just the parts you need. While realizing all of the tangible benefits of consolidating your development and manufacturing steps, you’ll…

Vetter Development Service

          Vetter, a leading provider of aseptically prefilled drug delivery systems, is poised to launch a new state-of- the-art facility at the Illinois Science + Technology Park in suburban Chicago. An expansion of Vetter Development Service, the Chicago site will support preclinical through phase II development projects. The 24,000-ft2 facility includes three cleanrooms, microbiology and chemical laboratories, and administrative offices.   Early-Phase Work   Developed at the urging of Vetter’s North American clients, the Chicago site,…

Preserving Chromatographic Selectivity While Improving Your Process Purification

          Chromatographic resins for a new purification process are initially selected based on prior experience and knowledge of the feedstock and the target compound. As the process scales larger, and hopefully through therapeutic commercialization, developers seek opportunities to maximize throughput, remove impurities, and reduce cost. Responding to the dramatic increase in batch titers over the past decade, products such as the Toyopearl GigaCap series of resins (first introduced in 2007) were developed to meet the titer…