July 2009

Tuning Oxygen Transfer in Small-Scale Fermentors to Mimic Manufacturing Productivity: A Case Study

Figure 1: An appropriate fermentation scale-down model is critical to allow comparison of lab scale studies to the manufacturing case. Modeling of fermentors increases confidence that a fermentation process is scalable within the confines of available equipment and that the data acquired are an accurate representation of production fermentations. Modeling fermentation oxygen transfer between development scales of 1–100 L and production scales of 1,000–10,000 L+ has been extensively studied, and there are numerous approaches including P/V, KLa, and OUR models.…

An Innovative Disposable Depth Filtration System

      The Zeta Plus Encapsulated System is a disposable depth filtration system designed for the bioprocessing industry where upstream cell culture clarification or downstream impurity removal is required. The Zeta Plus Encapsulated System consists of two product lines: a small system that is ideal for lab-scale production or scale-up studies, and a large system designed for production-scale biomanufacturing. Each is composed of a filter holder, a set of top and bottom manifolds, and a flexible number of capsule…

Hydrating Media Powder at the 200-L Scale Using a Magnetic Mixer

Figure 1: ATMI® LifeSciences offers five different disposable mixing technologies that provide varied cost, operational, and performance advantages over conventional stainless steel mixing vessels and competing disposable mixers. Criteria for selecting the best ATMI mixing technology include scale, particle, and sheer sensitivity, mixing power, physical fit, and economic considerations. This application note illustrates how the LevTech® Magnetic Mixing system performs in a demanding media mixing application. Introduction The LevTech Magnetic Mixer is a compact and noninvasive single-use mixing system. The…

Hi-Tech Components for Holistic Cultivation

Bioengineering AG looks back at over 35 years of experience in the planning and construction of biotechnological plants. Holistic solutions have become the status quo: from inoculation to harvest, from feed line to CIP-system, and from automation to validation. Because we do not want to limit our know-how to customers fermenting with Bioengineering equipment, we made components for all process steps available as single parts. To support progress in biotechnological processes, we also develop custom-made components for special applications. Operational…

Designing, Developing, and Delivering Our Clients’ Biopharmaceuticals

      Eden Biodesign is a globally integrated biopharmaceutical and vaccine contract biomanufacturing company. We are an expert provider of consultancy, biopharmaceutical process development, and CGMP manufacturing services. Our rarely found blend of experience and expertise, gained from providing services to a worldwide client base, ensures that the clinical medicines we develop are regulatory compliant and optimally positioned for further clinical and commercial development. Our state-of-the-art facility in Liverpool, UK, is licensed to produce clinical products, which is best…

Eshmuno™ Resins for Biochromatography

Figure 1: Production of biopharmaceuticals has over recent years evolved from simple scale-up of lab-based techniques into a much more engineering-driven task. The entire industry has matured. Safety and efficiency are key drivers in this new era. Large and increasing production volumes of biopharmaceuticals create a need for further development of chromatographic stationary phases. The main focus of resin development has been to increase productivity, which can be achieved by a combination of improved pressure-flow resistance along with increasing the…

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…