July 2010

Thermo Scientific HyClone Cell Boost Process Supplements

          Major drivers in biopharmaceutical development and manufacturing include improved performance in bioprocess cell culture through increased cell viability, product quality, and yield. Success has been achieved in addressing these drivers using Thermo Scientific HyClone Cell Boost by providing solutions that include strategic supplementation of nutrients based on metabolic profiling of cells and media at various stages of the bioprocessing cell culture campaign. One of the greatest improvements is derived from increased viable cell concentration and…

Avid Bioservices

Avid Bioservices offers a fresh approach to the Contract Manufacturing organization (CMO)–client relationship: fully integrated services across the process chain, including cell line and process development, analytical methods development, cGMP manufacturing, fill/finish, regulatory submission, and commercialization of biologic drug product or drug substance. our expertise enables our clients to succeed in their ventures. As a wholly owned subsidiary of Peregrine Pharmaceuticals, a clinical-stage biotech company with a management team experienced in the commercialization of therapeutic proteins, we know what it…

Nuvia™ S Media

          Increased productivity and reduced costs continue to be the driving forces in process development. Recent advances in upstream processes have dramatically improved the productivity of cell culture fermentation. However, prolonged fermentation and high concentration of monoclonal antibodies (MAbs) at harvest may also lead to product degradation and/or aggregation. Clearing these unwanted by-products remains one of the main challenges in downstream processing of therapeutic MAbs. Media with high binding capacity for target molecules and significant resolution…

A Responsible Business

          At a time when most companies endure the effects of a global economic melt-down, ALLpaQ™ seizes the opportunity for growth on the international stage. ALLpaQ™ Packaging Ltd. develops, manufactures, and supplies standard and custom bioprocess containers for the storage, transportation, and handling of biopharmaceutical fluids on both three-dimensional (3D) and two-dimensional (2D) design platforms. During the past twelve months, ALLpaQ™ has emerged as a strong contender on the world stage in providing packaging solutions to…

Rapid Optimization of Single-Use Bioreactor Performance

          Whether evaluating conventional stainless steel or single-use bioreactors, every system must accomplish the same thing: control a bioprocess for an intended result. The result may be biomass, product titer, substrate conversion, or any number of complex, process-specific productivity measures. Each system shares the same basic elements, including a bioreactor vessel and a gas addition subsystem. The vessel uses an agitation subassembly, gas sparger, and in some cases, gas overlay elements. These must be properly engineered…

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…

From DNA to Clinic

          A clear mandate has emerged throughout the industry to improve the timelines from candidate identification to phase 1 clinical trials. The goal of reducing the time to phase 1, combined with increasing titers and regulatory requirements, presents novel challenges to downstream development. To meet these challenges, Boehringer Ingelheim has developed the BI-Purification Excellence (BI-PurEx) strategy to shorten the development time to clinical trials while improving process understanding during early development phases to ensure a safe,…

More Than 25 Years Listening to the Bioprocessing Market

          Applikon Biotechnology is the world’s leading manufacturer of glass autoclavable vessels. Over 25 years ago, autoclavable vessels were sold as systems by many companies. When large west-coast biotech companies wanted a modular approach and also wanted changes in the design of the vessel, Applikon listened and complied. The glass bioreactor is now the standard of the industry and is sold in similar forms by many of Applikon’s competitor. Applikon has kept its focus on the…

Bioprocess Data Management

          IDBS provides a flexible data management solution that meets the diverse demands of biologic drug development based on our extensive experience working with global biopharmaceutical and contract manufacturing organizations. the IDBS Bioprocess data Management solution enables streamlined execution of process workflows, improved data access, sharing and reporting, and the process insight needed to successfully reduce the time and cost required to deliver new biologics to market.   Managing Diverse Data   Biopharmaceutical companies generate a…

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…