2010

Is Bovine Albumin Too Complex to Be Just a Commodity?

    For decades, the complexity of albumin has been researched extensively, yet many manufacturers and users of the protein have treated it more as a commodity. Because albumin has been readily available, suppliers and purchasers alike have frequently relied on more obvious measures of “purity” and other minimal release criteria to make their decisions. If a lot does not perform well in practice, the typical supplier’s response has been to investigate the manufacturing process for deviations, then correct them…

Using In-Line Disposable Pressure Sensors to Evaluate Depth Filter Performance

    Development of a recovery process for a fed-batch mammalian cell culture product involves several objectives: process scalability, robustness, maximizing product yield, elimination of subsequent purification steps, and low cost of goods. In an effort to achieve those objectives, we developed a three-stage primary recovery process to remove biomass and clarify the feed stream for downstream column chromatography (Figure 1). The initial stage involves removal of whole cells and larger cellular debris using a continuous disc-stack centrifuge. Depth filtration…

Novel Affinity Ligands Provide for Highly Selective Primary Capture

    Downstream processing of biopharmaceuticals is costly and time-consuming, often involving multiple steps with significant time and energy expended on maximizing product quality and yield. Affinity chromatography is one of the simplest and most effective methods for purifying protein and peptide therapeutics, offering reduced process steps and therefore higher yields than nonaffinity methods can provide. Protein A is widely used for affinity purification of monoclonal antibodies (MAbs), Fc fragments, and Fc fusion proteins. But it is a challenge to…

Global Marketplace

Quality Testing Product: Palltronic Flowstar IV instrument Applications: Filter integrity testing Features: The Palltronic Flowstar IV integrity test instrument is designed for speed and accuracy in laboratory and cleanroom operations. It offers up to date networking and automation options. Lightweight, ergonomic, and developed in accordance with both GAMP and 21 CFR Part 11, the instrument is supported by detailed qualification documentation and worldwide technical and aftersales support. Contact Pall Corporation flowstar@pall.com www.pall.com Anion Exchange Product: Toyopearl Q-600C AR anion-exchange resin…

IBC’s 24th International Antibody Development and Production

Antibody Development and Production is regarded as the most comprehensive event that delivers industry best practices across the spectrum of upstream and downstream processing. By attending, you will learn how companies are developing the latest molecular assessment approaches to optimize manufacturability and product quality and how they are applying smarter and faster tools for rapid process development. Industry leaders will assess the state of the industry and offer solutions to overcome the current capacity issues as they work towards their…

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…

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,…