July 2009

BD Select™ CD1000

Figure 1: Every cell line has unique nutritional requirements that must be properly balanced to achieve peak performance. However, production demands and tight timelines can make it challenging to conduct a base medium optimization for each individual cell line. To address this issue, BD has developed Select CD1000, a new, chemically defined platform medium using the proven methods of the BD AutoNutrient™ Media Design Service (AMDS) including design of experiments (DOEs) developed specifically for biopharmaceutical cell lines. BD Select CD1000…

Advantages of Archived Standard Curves for the Quantitative Bacterial Endotoxins Test

Figure 1: The bacterial endotoxins test (BET) is required for most parenteral drugs and medical devices that come into contact with the human bloodstream. Limulus amebocyte lysate (LAL) derived from horseshoe crabs is used for the BET, and several methodologies have been developed. Popular quantitative LAL techniques are the kinetic turbidimetric assay (KTA) and the kinetic chromogenic assay (KCA). It is, however, well known that the endotoxin standards used in both those assays are profoundly influenced by the techniques and…

Characterization-Based Manufacturing Process Development of Protein Therapeutics

      KBI Biopharma is a leading contract development and manufacturing organization for the biopharmaceutical industry. We accelerate and optimize drug development and manufacturing programs for our client partners, including global pharmaceutical and biotechnology companies and organizations in biodefense. Our clients benefit from faster time to market and lower cost of manufactured goods.   Ongoing Innovation   We are continually employing new technologies for the analysis of proteins and developing new partnerships, technologies, and services to enhance biomanufacturing. Our…

Preparation, Filtration, and Distribution of Buffers in Modern Bioprocesses

Buffer preparation and distribution are among the most common unit operations in biotherapeutic production. Despite the sheer volume of buffer consumed in bioprocessing and the importance of buffers in nearly every process step (e.g., cell growth, chromatographic separation, final formulation), buffers generally receive less attention from process development and process improvement teams than more challenging areas such as media preparation or active pharmaceutical ingredient (API) production. As one researcher stated, “buffer preparation is not valued as a strategic core competence…

The Next Step in Implementing Disposables

Biopharmaceutical manufacturers face increased pressure to commercialize new drugs faster and at a lower cost. To meet existing and future demand and maintain a competitive advantage, many manufacturers are striving to develop increased efficiencies within their manufacturing processes. This is where single-use systems — particularly single-use transfer lines — can deliver significant value, including added flexibility, improved production yields, and increased cost savings. The trend today is toward transfer lines or tube sets that use single-use connectors and filters to…

Assay Miniaturization Saves Time, Labor, and Resources to Boost Overall Efficiency and Productivity

ELISA-based sandwich assays have been a traditional workhorse across the drug discovery continuum for many years, but they have significant limitations. Gyros® offers a more efficient solution for performing high-throughput, automated immunoassays on a miniaturized, fluorescence-based platform. A head-to-head comparison of the microfluidics-based Gyrolab® technology and ELISA demonstrates clear distinctions: Speed — Gyrolab yields assay results within 1–1.5 hours (including sample preparation), whereas ELISA can take a full day to test only a few samples Dynamic range — Gyrolab provides…

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…