Biopharm International back issues from October 2007:
New Standards in Virus and Contaminant Clearance
Oct 01, 2007; ... High resolution, combined with relative simplicity, has made packed-bed chromatography the central enabling technology in bioseparation. A major concern today is whether column chromatography will be able to cope with the dramatically increasing product titers in fermentation. Unlike in ...
Disposable Biopharmaceutical Processes-Myth or Reality?
Oct 01, 2007; ... With low capital requirements and high flexibility, disposables offer many options for start-ups. ABSTRACT Biopharmaceutical processes typically require a significant investment in equipment-often a substantial obstacle for start-up companies. The risk of drug development failure ...
Disposable Membrane Chromatography-Counting the Cost
Oct 01, 2007; ... Disposable chromatography has important economic advantages over traditional columns. ABSTRACT Membrane technology is cited as one of the most exciting current market trends in the biopharmaceutical industry. This article examines the principles of membrane chromatography and ...
Improved Downstream Process Design for Human Monoclonal Antibody Production
Oct 01, 2007; ... A two-step process-a cation exchange capture column followed by anion exchange flow-through membrane chromatography-resulted in >80% process yield, higher batch capacity, and shorter process time. ABSTRACT Affinity purification schemes for antibody production have certain ...
Endotoxin Reduction Using Disposable Membrane Adsorption Technology in cGMP Manufacturing
Oct 01, 2007; ... Membrane-based chromatography technologies sometimes offer advantages over resin-based technologies. ABSTRACT The bioprocessing industry is increasing its use of membrane chromatography technology, especially for contaminant removal. The high flow rates, ease of use, ...
Disposable Chromatography
Oct 01, 2007; ... Single-use membrane chromatography as a polishing option during antibody production is gaining momentum. ABSTRACT Monoclonal antibodies (MAbs) continue to dominate the biopharmaceuticals market and their demand is predicted to increase dramatically over the next decade. This ...
The Effect of Flux Decay on a 20-nm Nanofilter for Virus Retention
Oct 01, 2007; ... In a single stage of the downstream purification process, 20-nm namofilters can clear both large and small viruses. ABSTRACT Viral clearance steps are essential for maintaining the safety and integrity of biopharmaceutical products. ICH Q5A mandates that the manufacturing process ...
The Renaissance of Protein Purification
Oct 01, 2007; ... Progress in downstream processes has not kept pace with increases in upstream yields. It is time for protein purification to make a comeback. Throughout the ages, great sculptors like Michelangelo have said that their work is about taking a block of marble and freeing a form that is ...
Small Biotechs Get Help at University Scale-Up Facility
Oct 01, 2007; ... Small biotechnology companies often need guidance during the development of new therapies-particularly when it comes to manufacturing. In Maryland, many companies find that support at the Bioprocess Scale-Up Facility offered by the University of Maryland's Biotechnology Research and Education ...
Operational Excellence Initiatives Lead to Competitive Advantage, Report Says
Oct 01, 2007; ... According to a new report published by Informance International (Chicago, IL), high performance pharmaceutical manufacturers outpace their peers in operational metrics such as asset utilization, overall equipment effectiveness (OEE), and operational availability by identifying and measuring key ...
What Comes Next
Oct 01, 2007; ... At the time of BioPharm International's first issue 20 years ago, many were uneasy about the science of biotechnology. The use of immortalized cell lines, for example, had only recently been approved, following an earlier prohibition imposed because of fears of transmitting tumorigenic host-cell ...
PDL BioPharma CEO Mark McDade to Resign, Company to Restructure
Oct 01, 2007; ... PDL BioPharma (Fremont, CA), has announced that a three-month internal investigation of the company's chief executive officer (CEO), Mark McDade, found no credible evidence to substantiate recent allegations made by shareholders. Nonetheless, McDade has decided to step down as CEO and member of ...
Sandoz Receives Biosimilar Approval for Epoetin Alpha
Oct 01, 2007; ... Sandoz (Holzkirchen, Germany), a division of Novartis, has become the first company to receive European Commission approval for a biosimilar of epoetin alpha. The approval was indicated for the use of biosimilar epoetin alpha in treating patients with renal anemia and those receiving ...
FDA Modernizes Biotech Regulation Over The Past 20 Years
Oct 01, 2007; ... From a small laboratory to a highly specialized organization, the FDA has grown with the changing needs of the biotech field Federal regulation of biologies began more than 100 years ago with the enactment of the Biologies Control Act of 1902. That act required licensing of ...
The Evolution of Protein Expression and Cell Culture
Oct 01, 2007; ... ABSTRACT The biopharmaceutical industry has seen an extraordinary evolution over the last 30 years since the first successes of recombinant DNA technology. Today, it represents the highest growth rate sector for the pharmaceutical industry. Developments in protein expression systems and ...
Contract Services Enabled the Biopharmaceutical Boom
Oct 01, 2007; ... In the next 20 years, new outsourcing business models will enabte biopharmaceutical companies to become more virtual. There wasn't much of a contract services industry when BioPharm International began publishing 20 years ago. Today's big names in biomanufacturing, including Lonza, ...
The Changing Landscape of Global Vaccine Development and Market Potential
Oct 01, 2007; ... ABSTRACT Vaccines stimulate the body's immune system to prevent or control specific diseases. Vaccines against major human infectious diseases such as pertussis, diphtheria, tetanus, and tuberculosis were developed in the early 1900s, and those for polio, mumps, measles, and rubella were ...
Process Chromatography: Five Decades of Innovation
Oct 01, 2007; ... ABSTRACT This article explores the development of process chromatography. Process chromatography was first applied to the removal of low molecular weight solutes from whey by gel filtration about 50 years ago. An analytical method using size exclusion chromatography was scaled up for ...
Protein Therapeutics and the Regulation of Quality: A Brief History from an OBP Perspective
Oct 01, 2007; ... As the biotechnology industry has matured through various stages of growth, regulatory agencies have evolved in response to the need to define quality standards. The history of the protein therapeutics over the past decades can be divided into five main periods. Each stage along the way ...
On the Biotechnology Frontier: Personalized Medicine
Oct 01, 2007; ... A Discussion with EJ Brandreth In 10 years, personalized treatment will become a significant part of the biotechnology sector. Favrille, a San Diego-based biopharmaceutical company, is one of a handful of firms on the forefront of personalized medicine. Because personalized ...
Applications of Multivariate Data Analysis in Biotech Processing
Oct 01, 2007; ... ABSTRACT Multivariate data analysis (MVDA) is quickly gaining popularity both in basic research and applied scientific fields as a statistical method of choice for examining variable interactions that were previously undefined. Multivariate data analysis by means of projection and ...
Biotechnology: Past, Present and Future
Oct 01, 2007; ... Thirty years after the first biotechnology company opened its doors, the sector is reaching a new level of maturity and globalization. Biotech companies once vied for strategic big pharma alliances; today Big Pharma looks to biotechnology for its future success. The current challenges ...
Industry Calendar
Oct 01, 2007; ... OCTOBER 14-18: CEPharm 2007 Location: Miami, FL www.casss.org/meetings/meetings.htm 16-17: Extractables and Leachables Location: Washington, DC www.intertechusa.com 22-23: Strategies in Technology Transfer for ...
Back to the Future
Oct 01, 2007; ... 20 years Today's innovators are breaking new ground, just as we did three decades ago. This time, the process is accelerated, as scientists learn from the past. Thirty-five years ago, Stanley Cohen and Herbert Boyer created the field of recombinant DNA technology. Three years ...
Glycosylation and the Demands of Antibody Engineering
Oct 01, 2007; ... A Discussion with Roy Jefferis Roy Jefferis examines precise questions about how sugars drive antibody function. Engineered antibodies are the quintessential success story of the biopharmaceutical industry today. Several approved antibodies have significantly advanced the ...
Biotech Manufacturing Grows Up
Oct 01, 2007; ... The industry, now 30 years old, is undergoing an important transition. The biotechnology industry has faced many challenges since its inception in the late 1970s. The ability to translate new discoveries into viable therapies that could be produced on a large scale and delivered to ...