February 2010

Biopharmaceutical Information Infrastructure 2.0

    This two-part article explores related tools and technologies that biopharmaceutical companies can leverage to build an efficient mechanism for capturing and delivering valuable information. In BioProcess International’s December 2009 issue, part 1 of the series focused on infrastructure selection and how hardware, software, and information systems form a kind of ecosystem (1). Simplicity, sustainability, and scalability can be achieved only when that trio is designed holistically. Part 1 further explored structured data capture and analysis tools, whereas this…

Microanalytical Techniques for Identifying Nonprotein Contaminants in Biologics

Proteins can aggregate at any point during pharmaceutical manufacturing. Regulatory agencies pay special attention to aggregates that can enhance immune responses and cause adverse clinical effects and those that can compromise the safety and efficacy of a drug product. Biopharmaceutical companies have stringent quality control (QC) procedures in place to ensure that their final products are free of contaminants and defects, including protein aggregates. Trained QC inspectors, however, can typically see product defects or particulate material only as small as…

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…

Embracing Biotechnology

If you have ever gotten frustrated trying to explain what you do at work to friends and family, we can relate. One of the greatest challenges perennially facing the biotech industry is the lack of public understanding of what biotechnology is and the many ways it contributes to a better world. A lack of solid public acceptance and support can make it all the more difficult to advance our advocacy efforts in the United States Congress and in state legislatures…

The Time Has Come for Automation in Bioprocessing

    As early as 1997, automation was ready to offer potential benefits to the bioprocess industry (1). Professor Bernhard Sonnleitner of the Zürich University of Applied Sciences’ Institute for Chemistry and Biological Chemistry suggested a “standard operating procedure” and pointed to the opportunities, requirements, and potential pitfalls of applying the principles of automation to bioprocess development and operations. If “boring and less interesting routine tasks” could “more efficiently and reliably be handed down to machines,” he explained, then personnel…

Minibodies and Multimodal Chromatography Methods

    Small, genetically engineered immunological constructs are being developed industry-wide for a growing range of in vivo applications. Examples include Fab, F(ab’)2, single-chain (sc) Fv, bis-scFV, diabodies, minibodies, and single-domain antibodies (1). Their small size potentially gives them access to tissues that are poorly accessible by intact antibodies; rapid clearance from blood and nontargeted tissues; lower immunogenic response; and eye-drop, inhalant, or oral administration. We report here on purification of an affinity-matured, humanized, antiprostate stem-cell antigen (PSCA) minibody for…