July 2009

Avecia Biologics: Development Expertise. Manufacturing Excellence

    Adedicated contract manufacturing organization supporting the biotechnology and pharmaceutical industries from preclinical process invention to postlaunch, commercial scale manufacture. Avecia’s industry-leading expertise enables customers to improve the cost-effectiveness and profitability of new therapies, while maintaining fast-track progress into, and through, its clinical development program.   Process Development and Scale Up   Avecia’s experience ensures process development is applied appropriately dependent upon the development needs of customer products at different clinical stages. Expression in E. coli and yeast, including…

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…

Isn’t It Time to Rethink Protein A?

    Figure 1:   During the past few years the biotech industry has started to move away from protein A-based platform systems for MAb purifications. The high cost of protein A resins, their modest dynamic binding capacities (DBC), and their limited base stability place restrictions on a developmental engineer’s ability to reduce process costs and improve throughput for a given plant footprint. Recent literature reports from Percivia (1) and Medarex (2) have described the use of improved cation exchange…

Pandemic Preparedness

SAFC Biosciences® since 1971 manufactures high quality sera, cell culture media, and specialty products for commercial firms using mammalian and insect cell culture methods to develop and produce biopharmaceuticals. SAFC Biosciences focuses on organizations involved in vaccine, human therapeutics, and animal health in all stages of development from preclinical through clinical phases I, II, and III, to commercial products. SAFC Biosciences has successful relationships with pharmaceutical, established and start-up biotechnology companies, contract research and manufacturing organizations, agricultural-related firms, and nonprofit…

A State-of-the-Art Facility Uses Disposables and Stainless Steel

Baxter Bioscience’s Hayward CGMP manufacturing facility offers dedicated capacity backed by 15 years of experience in developing and manufacturing monoclonal antibodies and recombinant proteins. We offer the firepower you need at any stage of development. Our goal is simple: to advance your biologic at any step — from preclinical to commercial — in the most timely and cost-effective manner possible. This state-of-the-art, licensed facility is located in the premier Biotech Bay for fast and flexible service. Just under 30 miles…

Launch of Planova™ 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…

Automatic Orbital Welding Systems Enhance Efficiency and Functionality

Orbital welding has long been the most popular and accepted method for joining 316L stainless steel tubing within the bioprocessing and pharmaceutical sectors. Yet as requirements for orbital welding continue to expand, so does the need to select a system that will pay dividends in more ways than one. Recent advancements in small, portable inverter power supplies help improve the consistency and reliability of welds as well as operator efficiencies. Open Platform Design To enable optimal efficiencies, a power supply…

Eight Questions to Ask Before Planning Your Single-Use Biomanufacturing Facility

Figure 1: Deployment of new GMP biomanufacturing capacity is a battle of tradeoffs (Figure 1). Push to accelerate your timetable? Cost or quality considerations must be compromised. Need to drive down total investment? Build-out time or quality must be sacrificed. As single-use technology establishes wider acceptance, certain tradeoffs may be lessened, but serious challenges remain. Figure 1: () Overcoming the limitations intrinsic to conventional biomanufacturing strategies requires a fundamental rethinking of bioproduction architecture. With the FlexFactory® biomanufacturing platform and a…

Boehringer Ingelheim: From Mind to Market

      The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since its foundation in 1885, the family-owned company has been committed to researching, developing, manufacturing, and marketing innovative products of high therapeutic value for human and veterinary medicine. Our therapeutic areas are respiratory, cardiovascular, central nervous system, urology, virology, rheumatology, metabolism, immunology, and oncology. Boehringer Ingelheim is one…

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…