CHT offers unique selectivity that effectively removes aggregates and the full range of process- and product-related impurities. While other approaches may require extensive development and tight process control, CHT methods are easy to develop and chromatographically robust, thus predictably delivering unmatched clearance performance in any situation. Download application note.
How To Prepare A Facility For The Biopharmaceutical Revolution By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. The Patheon facility in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?
Guest Column: Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers By Dr. Kirk Beebe, Director of Application Science, Metabolon, Inc.
Biologics are an integral part of the landscape of current therapies as pipelines continue to fill with them. Due to their importance, and this ever-expanding pipeline, the demands continue to escalate due to cost pressure, competition, regulatory requirements, disposable systems, and biosimilars. To date, these demands arguably have primarily been met with empirical understanding. However, there is a critical need for new approaches, tools, and technologies to deliver deeper understanding beyond the empirical realm.
Guest Column: The Importance Of Scaling Single-Use Equipment By Maik W. Jornitz, President, G-CON Manufacturing LLC
Process equipment choices, whether multiuse or single-use, are commonly made early in medicinal drug development activities and in test labs. Choices made in the test lab about which equipment would be tested are often dependent on either the availability of the equipment or knowledge about it. This often results in a legacy equipment choice. However, since the volumes used within the early drug development stages are very small, the process equipment used might not represent the process scale design or, even worse, is not scalable to process volumes. A proper plan and scalability investigation should precede the choice and testing of equipment, especially when being single-use.
Application Note: Compound Profiling And Toxicity By Metabolon
Utilizing a systems approach to drug discovery has generated a multitude of high affinity compounds for various classes of molecular targets with different degrees of disease state validation.
IBC Life Sciences' BioProcess International Conference & Exhibition, the industry's #1 BioProcessing event, is taking place October 20 to 23, 2014, at the Hynes Convention Center in Boston, MA. Find new ideas and make new contacts to help you meet the demands of diverse product portfolios in an evolving biomanufacturing landscape. Download a copy of the brochure today to see what this year’s event has to offer. http://bit.ly/1kwZCAK
Envirotainer presents its latest addition to its portfolio of active temperature-controlled air cargo containers. Designed for the most extreme requirements of the healthcare industry, the RAP e2 container maintains product temperatures in the +2°C to +8°C range, controlled room temperature (+15°C to +25°C) range, or at any chosen set temperature between ±0°C and +25°C in nearly any ambient condition appearing along shipping routes globally. The RAP e2 is a certified air cargo ULD (unit load device) ensuring seamless handling throughout the supply chain worldwide. The unit can be carried on board the most common wide-body aircraft types.
The following article shows three excerpts from some of the more common “observations” noted in Form 483 letters. (The names have been left out in this application note, but are a matter of public record). Each of these deviations involved environmental conditions (temperature, humidity, etc.) in a variety of GxP settings; they range from failure to properly validate containers for human cell and tissue products to a lack of temperature records in an aseptic processing area of a drug manufacturing facility.
To assist our audience with getting the specific scientific and business information they need to do their job better, we are narrowing our editorial coverage of this site to the bio manufacturing industry. As a result, this September, Bioresearch Online will become BioProcess Online.