Thursday, June 16, 2016 Daily Archives

From the Editor

Audience: the key element behind all style and content decisions in any spoken or written material. When publications existed only in print, audience-related criteria were easier to maintain than they are these days. Bound periodicals lived in libraries sequestered by subject. Unless you knew where “your†material lived, you were unlikely to stumble upon it — but information could get lost. Manual crossreferencing wasn’t easy, and I would not want to return to the days before powerful Internet search engines!…

Spotlight

Infectious Agents: A Global Effort Worldwide Commitment to Fight Antimicrobial Resistance: Medical, business, and government officials from around the world gathered in Amsterdam for the ECCMID 2016 Conference in April 2016. Hosted by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), the meeting reinforced its attendees’ commitment to fight antimicrobial resistance in a concerted effort. During an interactive session hosted by ESCMID and the Netherlands Society of Medical Microbiology (NVMM), researchers and representatives of the Dutch healthcare administration…

Bacteriophages, an Alternative to Antibiotics: Challenges and Possible Solutions for Bringing Them to Market

Bacteriophages are viruses (consisting of a genome contained within a protein coat) that specifically infect bacteria. They are the most abundant living entities on earth — the estimates range from 1030 to 1032 in total — and play key roles in regulating the microbial balance in every ecosystem where that has been explored (1). Bacteriophages are genotypic and phenotypically different from viruses that infect Archaea (Archaeovirus) and Eukarya (Eukaryovirus). The name bacteriovirus has been proposed as scientifically more accurate (2).…

Bridging Polymer Science and Biotechnology Applications with Single-Use Technologies

Implementation of single-use technology in the biotechnology industry is increasing every year. One major interest has been understanding the interaction of extractables with protein and cells for applications ranging from cell banking to biopharmaceutical manufacturing. In October 2015, the Engineering Conference International (ECI) organization hosted a conference in Leesburg, VA, to explore how the science of plastic applies to bioprocessing. The “Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications†meeting brought together experts from different fields to share issues, understanding,…

Quality By Design for Monoclonal Antibodies, Part 1: Establishing the Foundations for Process Development

The quality by design (QbD) modernized approach to pharmaceutical development is intended to provide regulatory flexibility, increased development and manufacturing efficiency, and greater room to innovate as well as improve manufacturing processes within defined ranges without obtaining regulatory approval first. QbD is a systematic developmental approach that starts with a clear goal in mind and emphasizes understanding of how variability in both process and materials affects a final product (1). Historically, product quality has been assured either with end-product testing…