July 2010

How to Balance High-Titer Processes with Consistent Quality?

          The high cell culture process (XD®) is a continuous process in which both cells and product are retained in a stirred-tank bioreactor using suspension mammalian culture. This is accomplished using a retention system: Fresh medium is continuously supplied, and metabolic byproducts are withdrawn and discarded through the retention system. XD® provides a controlled environment that leads to consistent product quality in terms of bioactivity, glycosylation pattern, and other product characteristics. Moreover, XD® technology is independent…

Microplate-Based Endotoxin Testing in GLP/GMP Environments

          Monitoring for contaminants is a critical step during the production process in the pharmaceutical and medical device industries. Endotoxin, a frequent contaminant, can cause fever, inflammation, headache, nausea, and even death. Found in the cell walls of gram-negative bacteria, endotoxin has routinely been detected by the sensitive and specific Limulus amebocyte lysate (LAL) assay. In the presence of endotoxins, LAL coagulates through an enzyme-mediated cascade, which has then been traditionally quantified based on gelation and…

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…

Process Development for Cell-Based Influenza Vaccine

          Influenza virus vaccines have traditionally been produced by infection of fertilized hen eggs. This labor-intensive approach requires large facilities, which has led to the development of large-scale mammalian cell culture methods for future virus vaccine production processes. The main focus of these studies was to use generic, established, and scalable techniques for industrial production of live influenza vaccines (Figure 1) and potentially also for other viruses independent of type or size. Development of three different…

Turn-Key Bioreactor Solutions

        top) and TruBio µC (bottom ()   In order to reduce scale-up costs and facility capital expenses, biotechnology companies are adopting single-use systems. To fully enable the single-use paradigm, automation software, hardware, and single-use sensors must be optimized; moreover, both validation documents and materials certifications must be readily available for cGMP implementations. Finesse provides turn-key, configure-to-order measurement and automation solutions for many single-use bioreactor types: “stirred-tank,” “paddle,” or “rocker” systems. The Finesse turn-key system is optimized…

Simple, Innovative Technology Improves QC Processes and Streamlines Production

          As production facilities strive for greater efficiency, a common practice is to seek process improvements in quality control (QC) operations. All production facilities share some common requirements for these QC checks, especially that they can be fast, simple, proven, and economical. In addition to this, the production of biological materials such as proteins frequently presents additional requirements, including the need to perform QC tests using very small volumes and the ability to measure the protein…

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)…

Detection of Microbial Contaminants in Water Samples Using the Milliflex® Quantum System

          Water is a key raw material used in manufacturing products within the healthcare, pharmaceutical, and biopharmaceutical industries. Microorganisms found in these water systems are mainly stressed, slow-growing strains characterized by long incubation times (five to seven days) before growth can be detected using traditional microbiology methods such as membrane filtration or pour plates. That time required before contamination can be detected in water can cause delays in product release and extend the storage time of…

Products and Services Designed to Facilitate Cell Culture Media Development

In response to the biopharmaceutical market needs, the focus of Irvine Scientific today is to provide chemically defined and animal-derived component-free cell culture media for use in the production of recombinant proteins. Drug development companies that do not invest in the costly and complex work of media development can rely on the services of Irvine Scientific to obtain and optimize formulas for their production cell lines. As the leader in rapid turn-around time for providing specially formulated products to clients,…

The Waters ACQUITY UPLC H-Class Bio System

          The complete characterization and analysis of biopharmaceuticals includes the application of size- exclusion chromatography (SEC) to measure protein aggregates and other size variants. Soluble protein aggregates in particular can contribute to immunogenicity. Accurate analysis and quantitation of biotherapeutic protein aggregates is therefore often required. Current HPLC/silica-based SEC methods can be time- consuming and unreliable. Their uncertain results may be due to changes in retention time, peak shape, or spacing between peaks as well as irreproducibility…