For most biotechnology and biopharmaceutical organizations, “business as usual†means a perpetual race to the finish line: Conceive a new invention, reduce it to practice, attain patent protection, repeat ad infinitum. But sometimes, the very technologies scientists use to expedite that chain of events (e.g., electronic laboratory notebooks and cloud-based laboratory data sharing) create security and authenticity holes. In essence, the more agile and sophisticated our work flow systems become, the more difficult it becomes to guarantee the…
2011
Optimizing Cryopreservation for Therapeutic Cells
Biopreservation suppresses degradation and enables postpreservation recovery of structure, viability, and function. Although there are several biopreservation techniques (indicated in “Biopreservation Methods†box), most laboratories use either standard cryopreservation protocols (the far majority) or vitrification (much more limited in broad systems application) when freezing cells for research and clinical applications. Isopropanol freezing containers such as the Mr. Frosty device from Nalgene Labware have made cryopreservation easier in many applications, and controlled-rate freezers allow users to program and manipulate…
An Update on Cell-Based Technologies
It’s always exciting to find out where the next meeting of the European Society for Animal Cell Technology will be. This venerable conference happens somewhere in Europe every other year. Recent sites have included Dublin, Ireland (2009); Dresden, Germany (2007); Harrogate, England (2005); Granada, Spain (2003); and Tylösand, Sweden (2001). This May, the gathering of animal cell culture scientists and engineers will convene in the palatial setting of the historic Hofburg Congress Center, formerly the Hapsburgs’ imperial residence…
Validation of Intermediate Hold Times
Because of the molecular complexity and relative fragility of biotherapeutics, validated intermediate hold times are critical for their commercial manufacture. Manufacturers typically conduct studies to define acceptable hold times for process intermediates to determine acceptable hold times for in-process production samples. A validation study defines maximum allowable hold times for all intermediate process stages based on product-specific data obtained during a hold study. A systematic risk assessment can determine which intermediate hold points should be validated (1). Hold…
The Role of Higher-Order Structure in Defining Biopharmaceutical Quality
Cosponsored by CASSS (an International Separation Science Society) and the US FDA, the 17th CMC Strategy Forum was designed to explore the relationships between higher-order molecular structure and quality of therapeutic proteins and peptides, vaccines, and blood-derived products. Understanding those relationships is important to defining and controlling the critical quality attributes (CQAs) of biopharmaceutical products. The forum program highlighted the current state of the art for analytical tools used to monitor higher-order structure. Case studies demonstrating the effects…
Development of an In-House, Process-Specific ELISA for Detecting HCP in a Therapeutic Antibody, Part 2
During biopharmaceutical manufacturing, final drug products can get contaminated with host-cell proteins (HCPs) derived from a production cell line. HCPs can elicit adverse immune responses, so regulatory authorities require accurate monitoring of their presence and concentration in final drug products. Because they are robust and offer good throughput, enzyme-linked immunosorbent assays (ELISAs) are the first choice for HCP detection to monitor product quality. Generic ELISA kits are commercially available for HCP detection with a number of commonly used…
A Novel Dry-Format Supplement for CHO Cells
The biotechnology industry is continually looking for new methods of improving titer of biotherapeutic proteins. Numerous reports show that nutrient supplementation improves productivity several-fold (1,2). Maintaining cells in a viable and productive condition is the ultimate goal and generally involves adding small volumes of concentrated nutrients to cell cultures. Important parameters for designing a nutrient supplement include ease of use, operator and site safety, and product storage footprint at a manufacturing facility. Traditionally, these supplements come as concentrated…
IBC’s 7th Annual Cell Line Development and Engineering
As cell line development and engineering mature, this industry faces new challenges and new lines of questioning. Where is the need for innovation? What enabling technologies will provide which companies with advantages over their competition? How can we leverage continued improvements to increase the speed of clinical and manufacturing facilities? How much can we improve understanding and development by applying “CHO-omics” and highthroughput systems? Do we have the tools to process and analyze all the available data? As biosimilars gain…
Global Marketplace
Technical Services Service: Pall Scientific and Laboratory Services (SLS) group Applications: Downstream processing Features: Established >40 years ago, Pall’s SLS group employs experts in chromatography, viral clearance, liquid and air filtration, microbiological process monitoring, tangential-flow and depth filtration, and blood processing. Services offered include validation, consulting, process development and proteomics, preinspection reviews, contamination analysis, and training. Instrument services include calibration, servicing, upgrades, documentation, qualification and technical support. Contact Pall Life Sciences www.pall.comSpectrophotometry Product: Evolution 200 series Applications: QA/QC analyses Features:…
Where Will Technology Take Cell Therapy?
The cell therapy industry’s biggest challenge is in manufacturing. Technologies are needed to support expansion of large numbers of cells for commercial production. A number of sources are presenting options: e.g., standard two-dimensional tissue cultures that “grow up†to Corning HYPERFlask and CellSTACK or Nunc Cell Factory systems; hollow-fiber–based equipment; and disposable bags and traditional stirred-tank bioreactors. Each has its place and application, but how can companies choose among them? Where and when do they initiate scale-up process…