Certain types of quality control (QC) testing are often outsourced by pharmaceutical companies, regardless of an organization’s size — typically because the company is either incapable of performing the assays in-house or does not wish to bring them into its facility. The decision to outsource may be based on the complexity of techniques involved special skills required for conducting the assays a need for biohazardous reagents such as radioisotopes limited testing frequency for the assays or (in biologics…
2010
Flexible Manufacturing
Flexibility has quickly become one of the most noticeable buzzwords of the bioprocessing industry. Understanding what constitutes a “flexible” process ranges from the simple application of one specific type of technology (e.g., single-use systems, automation, standard controls) to a somewhat extreme concept of a “throw-away” process. But whatever the definition, the factors leading to the need for more flexible approaches to biomanufacture are clear: Rapid, sometimes unexpected, changes in a company’s business situation and/or product portfolio (whether for patients or…
How Pore and Fibrous Interstice Structure Influence Filter Performance
When bioprocess liquids bearing suspended particles are filtered, retained particles can block and clog membrane filter pores. The pore size rating of a filter should be selected to retain objectionable particles by sieving, and the aptitude of its polymeric composition for adsorptive sequestration of those particulates also needs to be known. The quantity and nature of retained particles require accommodation if filtrative removal is to be considered successful. Too extensive a particle load will prematurely block a filter’s…
Are Generic HCP Assays Outdated?
Biomanufacturers face a conflict between low-cost generic host cell protein (HCP) assays and highly sensitive but more costly process-specific HCP assays that are usually not initiated until the proof-of-concept stage. But drug developers cannot expect sufficient sensitivity from most commercially available generic assays. For some companies, multiproduct HCP assays could offer a solution to the dilemma. Biopharmaceutical manufacture using genetically modified microorganisms and cell lines is typically associated with contamination by process-related impurities. One of the most important…
Improving IEX Throughput and Performance with Differentiated Chromatography Sorbents
Optimized upstream processing and high-productivity cell culture increase not only target protein titers, but also impurity and contaminant concentrations to be removed from large volumes of feedstock. Simultaneously, biopharmaceutical drug production is increasingly driven by manufacturing cost reduction. These facts together increase the pressure on downstream processing and create an urgent need for more productive and streamlined chromatography operations. Key parameters to consider for enhanced process economics in chromatography are higher protein binding capacities at high flow rates…
Global Marketplace
Stem Cell Harvesting Product: CellCelector stem cell picker Applications: Stem cell projects Features: Through its distribution agreement with AVISO GmbH, TAP offers the CellCelector automated stem cell picker to the US, Canadian, Irish, and UK markets. The noninvasive system automates selection and harvesting of murine and human stem cells to reduce associated time and costs in research and development. Lifelike images of cells before harvest allow users to document and standardize the quality of cells chosen. The system compliments TAP’s…
IBC’s Seventh Annual Single-Use Applications for Biopharmaceutical Manufacturing
Many companies are adopting single-use technologies. This program begins with a workshop that showcases the cutting-edge implementation experience of CMOs and start-up companies. The complete program includes the latest case studies and strategies for single-use bioprocessing, including development of a fully disposable downstream train, disposable bioreactors and sensors, and other components. Validation for applications involving the reduction of extractables, leachables, endotoxins, particles, and other risk factors will be explained. A shared session with the colocated vaccine conference gives an in-depth…
The Collaborative Future: A Case Study
In our February 2010 special report, “The Time Has Come for Automation in Bioprocessing,†one theme that made itself clear was the need for vendors, biopharmaceutical companies, and sometimes even regulators to work together toward the goal of better, faster, and cheaper product development through (among other things) automation technologies. Martin Rhiel of Novaris cell and process R&D told us, “It would be really nice to just buy it and implement it, but this doesn’t always work…Nowadays, the…
Are “Land Mines†Hiding in Your Supplier Records?
A growing trend in US Food and Drug Administration (FDA) warning letters has been citations for “no justified rationale.†Since 2004, warning letters taking companies to task for poorly documented decision-making and risk-assessment practices has more than doubled — from two in 2004 to four in 2008 and five in 2009. These citations are always in relationship to risk-based decisions: sampling (what, how often, and how much), nonconformances and corrective/preventative actions (when is “root cause†actual root cause,…
The Game Changer
Single-use technologies are coming of age and joining other driving forces to reshape the landscape of biopharmaceutical industry. This innovation has created new platforms for bioprocessing, offering competitive advantages and tremendous opportunities to current biomanufacturers. Moreover, the increasing acceptance of disposable systems with proven success will help enable niche products and bring emergent players to the market. The Age of Stainless Steel The discovery of DNA structure in the middle of the 20th century led to numerous breakthroughs in biological…