July 2009

Analytical Strategies for Monitoring Residual Impurities Encountered in Bioprocessing

    Profiling of impurities in biopharmaceuticals and their associated intermediates and excipients is a regulatory expectation. Since residuals are typically present at low levels in difficult sample matrices, development and validation of assays can be quite challenging (Figure 1). Matrix types can vary greatly due to the fact that sampling at a variety of process steps is required to accurately monitor throughout the production process. Figure 1: ()   Some residual impurities are introduced in the upstream steps as…

Optimization and Scale-Up of a Downstream Antibody Process Using a High-Throughput Approach

Figure 1: The recent successful production and application of new therapeutic antibodies has increased the demand to develop the next generation of antibodies. The race to develop new antibodies requires excellence in process development and full-scale production. Following the discovery phase, potential drug targets are taken from early clinical phases to market approval. During this process, efficient screening tools are important for the exploration of the experimental design space — in line with US FDA quality by design (QbD) initiatives…

Complete Single-Use Solutions

To reduce scale-up costs and facility capital expenses, many biotechnology companies are transitioning their stainless steel infrastructure to single-use or disposable systems. As single-use bioreactors have matured, their market acceptance has rapidly expanded. The move to disposables is in many instances driven by reduction in sterilization and cleaning requirements, improved plant flexibility for multiproduct manufacturing, reduced product changeover costs, and faster time to market for new products. To fully enable the single-use paradigm, the automation software, hardware, and single-use sensors…

Microvolume Sample Quantitation for Bioprocessing QC, Manufacturing, and Analytical Labs

In industries where implementation of process analytical technology (PAT) is bringing significant benefits and improvements to many processes, any new supporting technology that helps manufacturing efficiency and lowers production cycle time is often adopted in various functional areas throughout the organization. Bioprocessing operations often need to determine nucleic acid or protein concentrations reliably and with fast sample turn-around time at various stages during manufacturing. A common practice today is UV-Vis absorbance spectroscopy using conventional cuvette-based spectrophotometers. However, a novel approach…

Developing Fusion Proteins for Therapeutics

Fusion proteins are generating a lot of excitement these days because of their targeted use in therapeutic treatments of cancer, autoimmune diseases, and metabolic diseases. The webcast “Recent Trends In The Development and Manufacturing of Fusion Proteins As Therapeutics” examines the practical applications of fusion proteins and the challenges that manufacturers face. Created by joining two or more genes originally coded for separate proteins or protein domains, a fusion protein results in a single polypeptide that includes functional properties from…

Expertise in Fluoropolymer Engineering Provides Unique Products for Biopharmaceutical Processing

For over 50-years, W. L. Gore & Associates has earned its reputation for providing innovative, high-value products such as GORE-TEX® outerwear, Elixir® guitar strings, and GORE-TEX® vascular grafts. As the company invented expanded polytetrafluoroethylene (ePTFE), Gore offers an unparalleled level of technical knowledge and experience with this versatile material. This know-how starts with a deep scientific understanding of fluoropolymers, particularly PTFE processing and fluoropolymer development. Gore’s unique technical agility enables the development of a wide range of processes, products, and…

Automated Bioreactor Feeding

Figure 1: Bioprocess monitoring and automatic feeding of key nutrients such as glucose and amino acids are critical to obtain optimal high productivity in cell culture systems. Here we present a complete, closed-loop system that integrates a Groton Biosystems Automated Reactor Sample System with a nutrient analyzer and a reactor control system that demonstrates a powerful, automated online, real-time feeding system. Materials and Methods A Groton Biosystems Automated Reactor Sampler (ARS-M) is connected to a four-vessel DasGip Parallel Bioreactor System…

Automation in Process Development

Figure 1: Overcoming the bottleneck is a key statement often heard in the context of bioprocessing. Acceleration of both up- and downstream processes have therefore become a general need in the biopharmaceutical industry. Not only because this will release resources to comply with the increasing numbers of drug candidates, but also because this will shorten the time-to-market, giving more time to realize a return on investment before the patent expires. Thus there is a need to apply new innovative methods…

Supporting Biopharmaceutical Visions

      ProBioGen AG is a specialist for mammalian and nonmammalian high-producer cell engineering and GMP manufacturing of biopharmaceuticals. Combining a deep molecular understanding of cells, scientific expertise, state-of-the art industry process engineering, and production know-how, ProBioGen is the partner of choice for biopharmaceutical companies seeking outstanding cell line development and manufacturing capabilities. Moreover, the company’s proprietary AGE1.cell lines® are licensed to several key players in the industry and enable cost-efficient and safe production of vaccines and proteins. ProBioGen…

A New Solution for Endotoxin Removal in Biomanufacturing Processes

EndoTrap HD® manufactured by Hyglos GmbH (former Profos AG) is a new revolutionary tool especially designed to meet the needs of pharma and biotech industry for the efficient removal of endotoxins in biomanufacturing processes. EndoTrap® HD fulfils all requirements for industrial applications, and it can easily be integrated in/at early or late-stage purification processes of biological substances such as proteins, drugs, antibodies, or vaccines. Background Endotoxins (lipopolysaccharides, LPS) are major contaminants found in commercially available proteins or biologically active substances.…