July 2009

A Dedicated Contract Development and Manufacturing Organization Focusing on the Delivery of Advanced Biologics for Customers Worldwide

Angel has provided contract development and GMP manufacturing services for recombinant proteins, antibodies, and vaccines since 2001. Responding to market demand, Angel has also built an impressive track record delivering advanced (live) biologics comprising cell therapies including stem cells, cellular vaccines, and bacteriophages. Angel is one of very few European companies providing specialist GMP manufacturing support of these products for international clients. Comprehensive Solutions Angel offers vertically integrated manufacturing solutions reducing risk, cost, and timelines for clients. We believe that…

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…

Single-Use Sensing Solutions

Figure 1: Single-use purification processes typically use peristaltic pumps to provide single-use fluid pathways. However, peristaltic pumps are known for generating severe pressure oscillations. These oscillations have an effect on the accurate measurement of the process, thus limiting the effective monitoring and controlling of system pressure. SciLog is pleased to announce a significant performance breakthrough in pressure monitoring: achievement of a 98% reduction in signal noise level associated with peristaltic pump pulsation. In this solution, a significant increase in the…

Ready-to-Use Devices for Optimizing Bioprocesses with Integrated Sensors

Figure 1: Bioprocess fermentors are typically equipped with real-time monitoring devices such as temperature, pH, oxygen, or even viable cell density. The advantages of on-line over off-line measurements are easiness of use, timely results, and the possibility of immediate responses to the measured value. By contrast with the well-equipped fermentors used for production, the disposables used in bioprocess development have lacked such on-line measurement devices so far. Cultivation conditions could be monitored only by means of off-line sampling, typically performed…

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…