August 2012

BioPharma Solutions

      BioPharma Solutions, a business unit of Baxter Healthcare Corporation, works with pharmaceutical companies to support their commercialization objectives by providing scientific expertise, sterile manufacturing solutions, parenteral delivery systems, and customized support services needed to meet the unique challenges that parenteral products face.   Meeting Parenteral Manufacturing Challenges   Parenteral manufacturing can be a complex process. Cytotoxics, antibody-drug conjugates (ADCs), highly potent compounds, biologics, and lyophilized products require specialized understanding. BioPharma Solutions offers a dedicated facility with experienced…

EcoPrime

      LEWA developed its first pulseless pump for liquid chromatography in the late 1970s and delivered its first chromatography system in the early 1980s. LEWA is the leader in supplying pumps used for pilot and industrial HPLC, SMB, and LPLC chromatography worldwide. A customer came to us several years ago requesting a low-pressure liquid chromatography system with a flow range of 20–2,200 L/h. They also wanted the ability to achieve linear gradient from 1 to 99%. We designed…

Expression of a Self-Assembling Antigen-Targeting Fusion Protein

    Figure 1: ()   The Pfēnex Expression Technology™ platform is a very powerful protein expression technology based on the microorganism, Pseudomonas fluorescens. The Pfenex platform can deliver a robust production strain with unprecedented speed and a success rate that transcends legacy production hosts. Traditional recombinant protein expression hosts such as E. coli, insect cells, and yeast tend to have high failure rates regarding their ability to produce high titers of soluble, full-length, active target protein. In addition, the…

Commercial Prefilled Syringe Filling

The commercial prefilled syringe line at Cook Pharmica can process up to 600 syringes per minute, 36,000 syringes per hour, or 70 million syringes per year. The automated, high-speed syringe line is fully enclosed in a barrier isolator to provide the highest level of aseptic processing available by removing the human element from the entire process. With the ability to operate in smaller batches or full-scale campaigning, the prefilled syringe line is capable of bridging clinical programs into commercial production.…

POROS® HQ 50 and GoPure™ Prepacked Columns

      Anion-exchange (AEX) products are commonly used as a polish step in product flow-through (FT) mode to bind impurities. Comparing resins with membranes and membranes with membranes is challenging because of the complicated and unique scaled-down model formats of the products offered by different vendors. A novel approach to AEX FT using a short, 5-cm length, packed-bed format with a faster operating flow rate is explained. The performance of commonly used AEX resins and membrane adsorbers, detailing dynamic…

A SciLog® MabTec™ Method for Manual Bolus Fed-Batch Versus MabTec™ Automated Continuous Fed-Batch

      SciLog’s MabTec™ is an add-on bioreactor maintenance system that can gravimetrically manage, automate, and document your bioreactor feeding or perfusion strategy. The MabTec™ upgrades many manual processes to walk-away automation with minimal investment in terms of capital or time.   Summary   MabTec™ combines accuracy with convenience to provide an ideal solution for cell culture feeding strategies. Based on the results, MabTec™ demonstrated the ability to increase protein production while eliminating several hours of manual daily operation.…

Comprehensive Global Capabilities and Extensive Scientific Expertise

      Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its broad portfolio of services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today. Working with clients of all sizes, Covance recognizes that your development program is as unique as the product you bring to our facilities. With over 250 different biomolecules successfully supported annually, Covance…

AbSolute® High Cap

The capture step in the downstream processing of monoclonal antibodies (MAbs) is often the bottleneck and the most expensive step due to the use of protein A media. In recent years, several new-generation protein A media have been launched on the market claiming improved MAb capture, or improved resistance to cleaning agents. AbSolute® High Cap, the new revolutionary protein A media by Novasep, maintains excellent DBCs at low and high velocities, therefore, providing substantially improved productivity and strongly reduced costs…

Bio on Demand

      NNE Pharmaplan has developed a new facility concept we call Bio on demand™. Facilities based on the Bio on demand™ concept can be established in one to two years. The result is a flexible facility that is fully operational, locally compliant, and with functioning quality systems. The Bio on demand™ concept involves a high degree of single-use technology to ensure cost-effective production and fast establishment. Facilities based on our Bio on demand™ concept can be delivered globally,…

Pharmaceutical Biotechnology Innovations in Manufacturing

Challenging conventional process technologies with innovation and forward-looking solutions lead to the next generation of manufacturing processes. With its biotechnology, chemistry, and fine chemistry capability, DSM has an extensive toolbox for developing the most economic and sustainable solutions for customers. DSM’s biotechnology uses microorganisms, enzymes, and mammalian cells to produce novel ingredients and improve existing food ingredients, (bio)pharmaceuticals, plastics, and chemicals. Mammalian Cell Culture–Based Manufacturing A state-of-the-art facility, located in Groningen, The Netherlands, is dedicated to the development, scale-up, and…