2008

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…

Mixing and Resuspension of High Powder Loads Using a Magnetic Mixer

Figure 1. The Newmix-Levtech Magnetic Mixer system is a compact and noninvasive single-use mixing system. Its heart is a mixing bag that incorporates an innovative, bottom-mounted, magnetically driven impeller capable of providing efficient high-torque mixing for all powder-liquid and liquid-liquid mixing applications. The impeller rides on a low-friction, inert bearing assembly designed to ensure low particle shedding while allowing mixing of very high powder loads in large liquid volumes. All product-contacting surfaces are 100% disposable. Introduction Powder-liquid mixing is a…

Closed-Loop Solutions to Improve Efficiencies and Yields Using Automated Online Sampling Systems for Bioreactors

Improving production quality, efficiency, and yield is the objective of every commercial biotechnology process. Automation of assay tasks now routinely performed manually directly improves production bioprocesses. The US FDA supports and encourages this activity through the process analytical technology (PAT) initiative within its regulatory structure. The features and benefits of the online series of Automated Reactor Sampling (ARS-M™) systems supplied by Groton Biosystems are detailed here. Online Automatic Assays Today the most vital late-stage and production assay measurements — with…

Purification of a Monoclonal Antibody Using a Combination of UNOsphere™ Rapid S and UNOsphere Q Media Ion Exchange Chromatography After Protein A Capture

Figure 1. Antibody-based drugs represent a growing segment of the pharmaceutical industry and one of the most promising classes of therapeutic drugs. The demand for protein-based drugs is expected to grow steadily for the foreseeable future. However, production of monoclonal antibody (MAb)–based drugs remains very costly, and solutions to lower production costs are needed. Downstream purification steps are becoming a target for cost reduction. The use of ion-exchange chromatography to directly capture MAbs from cell culture streams or as a…

Scale Up on Efficiency in Biologics Contract Manufacturing

Wacker Biotech has a 20-year track record in manufacturing microbial-derived biopharmaceuticals, giving us a deep understanding of such products and of our customers’ needs. We provide comprehensive contract-manufacturing services and proprietary technologies that significantly lower the cost of goods. Our customers benefit from a comprehensive service for the development of robust, highly efficient, and readily scalable processes and GMP-compliant manufacturing for clinical trials and commercial supply. Service We work in close collaboration with our customers. Projects are managed by dedicated…

Avecia Biologics: Development Expertise. Manufacturing Excellence.

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, their clinical development programme. Process Development and Scale Up Avecia’s experience ensures that process development is applied appropriately dependent upon the development needs of customer products at different clinical stages. Expression in E. coli and yeast, including Pichia pastoris and Saccharomyces cervisiae Wide range of constructs and expression options including developing a customer’s existing system or creating one de-novo…

Microfluidics Offers M-110P Microfluidizer® Processor

Microfluidics offers its M-110P Microfluidizer® processor, a benchtop laboratory machine that requires no compressed air or cooling water for hydraulics. Designed to operate reliably, quietly, and efficiently at up to 30,000 psi process pressures, the portable M-110P requires only a standard 20-amp, single-phase “household” electrical outlet and can easily be incorporated into any laboratory setting. Using Microfluidics’ fixed geometry diamond interaction chamber technology and ceramic plunger, the M-110P easily enables the production of nanosuspensions and nanoemulsions, as well as liposomal…

Building a Community of Users and Expanding Novel Cell-Based Applications of the WAVE Bioreactor

Figure 1. Developed in 1996, the WAVE Bioreactor™ and Cellbag™ disposable bioreactor systems have revolutionized cell culture for commercial and R&D applications in the production of cell-derived products using animal, insect, plant, microbial, and virus cultures. Oxygen transfer and mixing are accomplished by the novel principle of wave-induced agitation. Wave action generates free surfaces for bubble-free oxygen transfer from the headspace of each Cellbag bioreactor, and it also mixes the fluid suspending cells or particles. This design eliminates the need…

The Global Biotech Community’s One-Source Contract Manufacturing Solution

Cook Pharmica is a full-service biopharmaceutical contract manufacturer located in Bloomington, IN. Cook Pharmica’s mission is to provide process development, flexible manufacturing, and comprehensive analytical services to the global biotech community; enabling its partners to bring their life-saving discoveries to patients. And with the recent announcement of its expansion into parenteral contract manufacturing, Cook Pharmica will serve the industry as a complete one-source solution. The current API manufacturing facility was designed to support clinical and small-scale commercial products and features…

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, pharmaceutical and biotechnology companies have relieved a little of that pressure by outsourcing functions to a limited extent, such as in packaging or distribution. Allowing a contract manufacturer to perform some of these operations frees up companies to focus on their core competencies. Today, however, some of the industry’s most eye-opening success stories are…