Thursday, July 1, 2010 Daily Archives

DNA Removal By Depth Filters in Bioprocesses

  Conclusion   The removal of DNA from cell culture broths and lysates may be required to accomplish the CBER-recommended concentration of DNA impurity of About the Author Author Details Michael Wang, PhD, is a Marketing Manager Bioprocess at 3M Purification Inc., 400 Research Parkway Meriden, CT 06450-1018; 203- 238-8795; Mwang9@mmm.com. REFERENCES 1.) Dorsey, J. 1997. The Role of Charge in the Retention of DNA By Charged Cellulose-Based Depth Filters. BioPharm 10:46-49.   2.)3MPI Application Brief: DNA Removal from Bioprocess…

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,…

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…

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…

Development and GMP Manufacturing of Biopharmaceuticals

With Richter-Helm BioLogics and Richter-Helm BioTec, over 20 years of experience in development and manufacturing of biopharmaceuticals and the innovative strength of high-performance teams are coupled with the solid foundation of the owner companies Gedeon Richter Plc. (Hungary) and HELM AG (Germany). Preclinical to Commercial Supply Richter-Helm BioLogics offers services for development and manufacturing of biopharmaceutical products from customers in the pharmaceutical and biotechnology industries. Richter-Helm BioLogics develops and produces recombinant proteins, plasmid DNA, and vaccines in microbial systems. Richter-Helm…

Biological Manufacturing

RecipharmCobra Biologics is the specialist biologics division of the Recipharm AB group, one of the leading contract development and manufacturing organisations in Europe. We provide a comprehensive range of services, from early-stage development to the supply of GMP material for Phase I, II, and III clinical trials. We are with you every step of the way. The Market Is Growing — So Are We We have provided contract development and manufacturing services to customers worldwide for more than a decade,…

Lancaster Labs Develops Extractables Database for LC/MS Analysis

The FDA has been focusing effort into evaluation of potential adulteration of drug products due to contact with packaging and closure systems, sample delivery devices, and components used in product manufacturing. Packaging includes components such as vials, caps, and stoppers. Drug delivery devices include nebulizers and inhalers. Components used during product manufacturing include filters, tubing, fittings, connectors, bioprocess bags, and bioreactors. Lancaster laboratories provides support by performing extractables and leachables testing. Extractables are compounds that can be extracted from a…

Formulation and Fill for a Vaccine with Alum Adjuvant

          The goal: Develop a CGMP formulation–fill process for a subunit vaccine–aluminum adjuvant complex. The challenge: To engineer a scaled-up process for vaccine–adjuvant suspension formulation and fill, ensuring a uniform fill per dose as well as a sterile product. The outcome: Florida Biologix scientists successfully developed the manufacturing, formulation–fill process and test methods. The process was conducted successfully in a scaled-down engineering run and at full scale, and 2,500 vials were tested, released, and shipped to…

Outsourcing GMP Biologicals

    Figure 1: ()   Selection of a CMO is critical to biologic drug development; and the primary selection criterion is experience. How do biotech companies measure experience? CMO experience can be measured in many ways — primary metrics include (1) total number of GMP processes developed by a CMO; (2) number of projects involving your strain; (3) number of projects involving your product type; (4) GMP production success rate; (5) total number of GMP lots produced; and (6)…

Recognized Biologics Center of Excellence

          This year marks the 10-year anniversary of Eden Biodesign, so we thought it fitting to reflect on our past and look to the future as we remain committed to growth, success, and our long-standing reputation for being much more than a CMO. Eden has grown from a single- roomed office to a multinational organization with locations in the United States and Europe as well as partner organizations around the globe. We operate a custom-designed, 41,000…