Recently added articles from Biopharm International:
Leached Impurity Found in Cubicin Stored in Cardinal Health's ReadyMED Pumps
Jun 01, 2008; Anonymous ... Cubist Pharmaceuticals, Inc. (Lexington, MA) informed Healthcare professionals on April 4 that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc ....
Merck Receives Warning Letter for Vaccine Operations
Jun 01, 2008; Anonymous ... The US Food and Drug Administration (FDA) issued a warning letter to Merck and Co. (Whitehouse Station, NJ) on April 28, citing numerous good manufacturing practice (GMP) violations at Merck's vaccine production operations in West Point, PA. The FDA also requested a meeting with senior ...
Genzyme Recalls Three Lots of Thymoglobulin
Jun 01, 2008; Anonymous ... On April 9, 2008, Genzyme Corporation (Framingham, MA) announced a recall of three lots of its organ-rejection antibody, Thymoglobulin, because of stability concerns. One of the lots of Thymoglobulin failed a visual stability test. The other two lots were recalled based on a predicted ...
Funding the FDA, Finally
Jun 01, 2008; Bush, Laura ... As we went to press, a Senate appropriations committee backed a bill to increase funding to the US Food and Drug Administration by $275 million for fiscal year 2009, including $100 million more for drugs. This matches the amount that FDA Commissioner Andrew von Eschenbach specified in his May 5 ...
FDA Finalizes CMC Guidance for Gene Therapy INDs
Jun 01, 2008; Anonymous ... The FDA has issued its guidance for chemistry, manufacturing, and control information that is included in investigational new drug applications (INDs) for gene therapies, called "Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational ...
3M Collaborates with IDRI on Vaccine Adjuvants
Jun 01, 2008; Anonymous ... 3M Drug Delivery Systems (St. Paul, MN) has signed a non-exclusive license agreement with the Infectious Disease Research Institute (IDRI, Seattle, WA) in support of vaccine research in developing countries. Under the agreement, 3M will donate its patented toll-like ...
Hans-Peter Meyer of Lonza Joins BioPharm International's Editorial Advisory Board
Jun 01, 2008; Anonymous ... Hans-Peter Meyer, PhD, vice president of innovation for future technologies at Lonza (Basel, Switzerland), has joined the Editorial Advisory Board of BioPharm International. Meyer has more than 30 years of experience in biotechnology, working with both prokaryotes and eukaryotes in ...
Heparin Products the Target of Deliberate Adulteration, Says Baxter CEO
Jun 01, 2008; Anonymous ... Baxter's heparin products appear to have been the target of a deliberate adulteration scheme, Baxter (Deerfield, IL) CEO Robert L. Parkinson said on April 29, 2008, in testimony before the US House of Representatives' Committee on Energy and Commerce, Subcommittee on Oversight and ...
Novavax Reports Positive Results for its VLP-based Trivalent Flu Vaccine Candidate
Jun 01, 2008; Anonymous ... VACCINE REPORT Novavax, Inc. (Rockville, MD) has received positive results from an immunogenicity study in ferrets inoculated with the company's trivalent seasonal influenza vaccine candidate made using its proprietary virus-like particle (VLP) technology. These findings will enable ...
Global Deals
Jun 01, 2008; Anonymous ... In Detail: DSM Biologics and Upfront to Develop a Fully Disposable Chromatography System for High Yield Cell Line Production DSM Biologies (Heerlen, the Netherlands), and Upfront Chromatography A/S (Copenhagen, Denmark) will collaborate to optimize Upfront's fully disposable ...
Considerations When Outsourcing the Production of Clinical Material
Jun 01, 2008; Ethier, Josée; Déziel, Chantal ... Proper auditing can ensure the selection of a capable contract manufacturer The selection of a contract manufacturing organization (CMO) can be a real challenge for many drug manufacturers. The situation is even more critical when clinical material is concerned, because of stringent ...
How to Evaluate the Cost Impact of Using Disposables in Biomanufacturing
Jun 01, 2008; Sinclair, Andrew ... To understand the overall cost impact of disposable technologies, it is necessary to build a robust model that covers the entire process The growing acceptance and adoption of disposable technologies raises the question, What is the cost impact of these technologies? This question sounds ...
Biotech Survives Difficult Opening to 2008
Jun 01, 2008; Burrill, G Steven ... In the current market crisis, biotech IPOs and financing are down, but partnering continues, and M&As are as hot as ever The past four months have been tough. Investors have been shell shocked in the wake of not only surging oil prices (compounded by the declining dollar) and the ...
A Rational Approach for Setting and Maintaining Specifications for Biological and Biotechnology-Derived Products Part 1
Jun 01, 2008; Apostol, Izydor; Schofield, Timothy; Koeller, Gerhard; Powers, Susan; Stawicki, Mary; Wolfe, Richard A ... ABSTRACT This paper discusses an approach for the establishment and lifecycle management of biological and biotechnology-derived product specifications. The views presented are consistent with the concept of Quality by Design (QbD), in which critical quality attributes (CQAs) are ...
Spotlight on Separation & Purification
Jun 01, 2008; Anonymous ... Virus Purification Kits Millipore offers two Fast-Trap Virus Purification and Concentration Kits, one for adenovirus purification and another for lentivirus purification. Purifying viruses after propagation in host cells is a critical step toward using viruses as vectors for genetic ...
Industry Calendar
Jun 01, 2008; Anonymous ... JUNE 9-11: 6th Annual Biodefense Vaccines & Therapeutics Location: Washington, DC www.infocastinc.com/biodefense 17-20: 2008 BIO International Convention Location: San Diego, CA www.bio2008.org 22-25: 2008 AAPS National Biotechnology ...
Modeling of Biopharmaceutical Processes. Part 1: Microbial and Mammalian Unit Operations
Jun 01, 2008; Nyberg, Gregg; Green, Ken; Hashimura, Yas; Rathore, Anurag S ... ABSTRACT The scale-up of processes from bench to commercial scale is challenging because of uncertainties about the physiochemical environment experienced by the cells at large scale. Process modeling tools can be useful in facilitating the scale-up and technology transfer of microbial ...
Validation Failure is Not an Option. Should it Be?
Jun 01, 2008; Krause, Stephan ... Under the current regulations, there is no system that allows a firm to openly deal with validation failures The International Conference on Harmonization (ICH) Q8-10 guidelines and the US Food and Drug Administration's out-of-specification (OOS) guidance document provide approaches that ...
Avoiding the Pain of Out-of-Specification Results
Jun 01, 2008; Nunnally, Brian K; McConnell, John S; Nunnally, Deedra F ... ABSTRACT The pharmaceutical industry does not have a good track record of applying sound statistical principles to the investigation of out-of-specification (OOS) results. Recently, Steven Kuwahara presented an article on the history of the OOS problem highlighting some statistical ...
New Technology Showcase
Jun 01, 2008; Anonymous ... Closure System The ì-Flask from Applikon Biotechnology is a reusable, gas-permeable closure system that is available in standard microtiter plate sizing. Published research shows the oxygen transfer rates are comparable to baffled flasks, eliminating the need for shake flasks. The ...