January 2010

Nutrient Supplementation Strategies for Biopharmaceutical Production, Part 3

    Scale-up studies are needed for assessing cell culture production system options and for testing nutrient supplementation techniques as well. With the many supplementation options available, choices need to be made as early in product development as possible because advantages can change with scale. One published fed-batch scale-up study testing from 3 L up to 2,500 L highlights items to be considered in addition to the nutrient supplementation process such as the impact of pH and CO2 control (1).…

Primary Clarification of Very High-Density Cell Culture Harvests By Enhanced Cell Settling

    In recent years biopharmaceutical manufacturing has demonstrated major improvements in MAb production, exhibiting product titers as high as 25 g/L often associated with very high cell densities (1). High-density cell cultures with >150 million cells/mL pose a great challenge in clarification and further downstream processing because of a need to remove a large amount of biomass and increased levels of contaminants from cell debris generated during cell culture and harvesting. Production of biological substances (MAbs, in particular) usually…

PAT-Based In-Line Buffer Dilution

    Technological advancement has taken protein expression titers from concentrations measured in mg/L to those measured in g/L over just a few years (1). Annual demand for antibodies has reached several metric tons, which has spurred production of >100 kg batches of protein at a time (2). As upstream yields continue to increase, downstream purification involving process solution preparation and delivery must increase in proportion to keep pace with demand. That has placed facility and instrumentation capacity constraints front…

Global Marketplace

Inline Sampling Product: STA-PURE fluid sampling Applications: PAT sampling Features: Gore’s sampling system can be directly connected to 25-mm Ingold ports. Previously, such sampling required the use of TC adapters and O rings that can leak or get stuck in vessel ports. The STA-PURE solution uses a high-purity, highly compressible platinum-cured silicone adapter integrated with a single valve device. A single-use silicone sleeve is attached and presterilized with the device. When the valve body is inserted into a vessel port,…

Biopharmaceutical Development and Production Week

IBC’s Biopharmaceutical Development and Production Week covers today’s critical issues from all angles to provide you with a deeper understanding of the forces affecting your company and driving the bioprocessing industry. Customize your learning and networking experience with access to 700+ bioprocessing professionals under one roof 103 presenters to share strategies and lessons learned 45 exclusive case studies five shared plenary sessions two exhibit halls with >60 supplier companies. Together, these five conferences deliver the latest technical and scientific approaches…

Quantitative Crowdsourcing

This past fall, we collaborated with researchers from MIT and Harvard Business School to develop and launch the Pharmer’s Market, a prediction market that aggregates the opinions, insight, and experience of a wide range of pharmaceutical professionals to forecast outcomes of drug clinical trials. The market is designed to be a showcase of how pharmaceutical development could run in the future. This concept was born when we agreed on a critical premise: Discovery should be a collective process. That isn’t…

Hurry Up and Wait?

From time to time we each experience the hurry to get somewhere, only to end up waiting for someone or something else. Today’s air travel seems to be nothing but “hurry-up-and-wait”: After you race to the airport two hours before your flight time, the plane ends up departing two hours late. Businesses suffer from the same disorder. For example, in the biopharmaceutical industry, this phenomenon is often evident in all the documentation that must be completed before a product can…

Improved HCP Quantitation By Minimizing Antibody Cross-Reactivity to Target Proteins

    Host cell proteins (HCPs) are process-related impurities derived from a host cell expression system that may be present in trace amounts in a final drug substance. During biologics development, it is important to demonstrate that a bioprocess is efficient in removing HCPs and that it provides consistent control of HCP levels. Several techniques are typically used for detection, quantitation, and risk evaluation of HCPs in biologics. The most common are enzyme-linked immunosorbent assays (ELISAs), Western blotting, sodium-dodecyl-sulfate polyacrylamide…