June 2013

Comparability Protocols for Biotechnological Products

Comparability has become a routine exercise throughout the life cycle of biotechnological products. According to ICH Q5E, a comparability exercise should provide analytical evidence that a product has highly similar quality attributes before and after manufacturing process changes, with no adverse impact on safety or efficacy, including immunogenicity (1). Any doubt about data from such studies could translate into unforeseen pharmacological or nonclinical studies — or worse, clinical studies. Selection of analytical methods and acceptance criteria that will be applied…

Biological Assay Qualification Using Design of Experiments

In 2012, the United States Pharmacopeia (USP) published a complementary set of three guidance documents on the development, analysis, and validation of biological assays (1,2,3). USP chapter recommends a novel, systematic approach for bioassay validation using design of experiments (DoE) that incorporates robustness of critical parameters (2). Use of DoE to establish robustness has been reported (4,–5), but to our knowledge its use in qualification or validation protocols for assessing assay accuracy, precision, and linearity is not described in literature.…

A Salt-Tolerant Anion-Exchange Chromatography Sorbent for Flexible Process Development

In most downstream purification processes designed for biopharmaceutical drug production, dilution and diafiltration sequences are unavoidable. Such operations are routinely used to adjust a feedstock or chromatographic fraction to the optimal conditions required for best process performances. Nevertheless, those steps are often time, water, and labor consuming without participating directly in final product purification. Because biopharmaceutical production is increasingly driven by cost reduction, a possible means for enhancing process economics is to streamline purification by eliminating these unit operations before…

10th Anniversary BioProcess International Conference and Exhibition

Join us in Boston this September to celebrate the 10th Anniversary of IBC’s “BioProcess International™ Conference and Exhibition,” a milestone event providing the tools and knowledge you need to meet the demands of increasingly diverse product portfolios in an evolving biomanufacturing landscape. The inaugural BPI Conference in 2004 gave the industry’s an opportunity to exchange experiences and knowledge to optimize manufacturing processes and accelerate programs. Fast-forward 10 years, and this has become the industry meetingplace for product and process development…

Biologics Have a Robust Pipeline

Earlier this year, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a report titled 2013 Report: Medicines in Development – Biologics. It lists 907 biologics currently in development at “America’s biopharmaceutical research companies.” The list includes biologics targeting more than 100 diseases that either are currently in human clinical trials or are under review by the US Food and Drug Administration (FDA). Of those 907 product candidates, the most common types are monoclonal antibodies (MAbs, 338), vaccines (250), and…

Keeping New Technologies Coming

The biomanufacturing industry is heavily invested in improvements in productivity and efficiency, and innovation is a critical component to ensuring gains in these areas. Yet that is not always the case. Suppliers and innovators in this market face greater challenges, and much longer product evaluation cycles than in other segments, for example the information technology or semiconductor industries. In the highly regulated biomanufacturing environment, changing any aspect of a process can potentially necessitate additional regulatory submissions to the US Food…

Drug Products for Biological Medicines

The California Separation Science Society (CASSS) held a Chemistry, Manufacturing, and Controls (CMC) Strategy Forum on drug products for biological medicines in July 2012 in Bethesda, MD. Topics included novel delivery devices, challenging formulations, and combination products. This CMC Strategy Forum aimed to promote an understanding of how best to increase the speed and effectiveness of drug product and device development for both large and small companies. Participants focused on areas that improve the likelihood for regulatory success, reduce risk,…