Thursday, July 1, 2010 Daily Archives

In-Process Control of pDNA Production on CIMac pDNA Analytical Column

          As the demand for plasmid DNA (pDNA)–based gene therapy and vaccines increases, large-scale, cost-effective, and reproducible pDNA production will be required. The key to success is a real-time, in-process control method that ensures a high percentage of supercoiled pDNA in the final product. CIMac pDNA Analytical Column allows the monitoring of degradation products (open circular and linear pDNA), the removal of impurities (RNA), and the assurance that each production step is yielding the amount of…

Biosafety Testing of Biologicals for Mycoplasma Contamination

          Mycoplasma contamination of cell culture (both of primary and continuous eukaryotic cell lines) is common and represents a significant issue of importance in the basic research, development, and production of biologicals. Contamination can alter virtually every physical and chemical property of cells (depending on the contaminating species and the cell type), potentially leading to unreliable results and perhaps unsafe biologicals, biopharmaceutical drugs, or viral vaccines. In fact, contamination may be present with no obvious change…

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…

BioManufacturing Network

          Diosynth Biotechnology, based in Research Triangle Park, NC (USA) and MSD Biologics (formerly Avecia Biologics) based in Billingham, UK have combined to form the BioManufacturing Network. Together the two organizations offer industry-leading CGMP contract manufacturing services for recombinant proteins, vaccines, and monoclonal antibodies with an attractive geographical footprint in the USA and Europe. Our combined expertise enables our customers to improve the cost-effectiveness of new therapies by providing fast-track progress into and through their clinical…

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 comprehensive 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 Biopharmaceutical Services provide…

Rapid Cell Line Development with Integrated Protein Analysis

          The standard cell line development pathway at many contract service organizations is based solely on selecting clones by growth and productivity with little or no analytical characterization of the expressed protein. The use of protein analytics to support selection of clones that match desired product quality is important for second-generation processes and will be of utmost importance for biosimilar development. CMC Biologics performs sophisticated protein characterization using state-of-the-art analytical equipment combined with our robust cell…