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Brief pharmaceutical news items for October 2008.
Allele Biotech and Orbigen Merge
Allele Biotechnology and Pharmaceuticals (San Diego, CA), a biomedical research and service company, acquired Orbigen (San Diego), a company that offers products and services in the fields of antibodies and molecular biology such as the baculovirus expression system.
The companies expect the merger to provide synergy and allow them to meet clients' research needs more efficiently and effectively than before. The combined scientific expertise of both companies has allowed them to expand new research-product lines significantly in areas such as user-friendly fluorescent proteins, novel antibodies, sensitive Luciferase substrates, genotyping products, and various protein-expression systems and assays.
Cirrus Offers Walk-In Stability Chambers
Cirrus Pharmaceuticals (Durham, NC) expanded its current capacity for stability storage by adding three walk-in stability chambers from Luwa (Raleigh, NC). Each chamber has 1100 ft3 of storage space, complies with current good manufacturing practices, and meets US Food and Drug Administration guideline requirements for stability. The additions provide long-term, intermediate, and accelerated storage conditions.
The new stability chambers will enable Cirrus to increase its formulation and strategic product-development services for various delivery routes, including inhalation, nasal, parenteral, oral, topical, and transdermal. In addition, Cirrus will enhance its release testing and stability testing in support of clinical trials and regulatory submissions. The chambers, including temperature and humidity mapping and monitoring systems, are scheduled to be completely validated by November 2009.
Nelson Laboratories Breaks Ground On New Building
Nelson Laboratories (Salt Lake City, UT) broke ground on a three-story, 48,000-ft2 addition. The new building will house space for administrative staff, along with the company's biocompatibility, microbiology, and pharmaceutical laboratory departments. The existing space in Nelson's current building will be used to expand all 12 laboratory departments.
Nelson plans to expand the space dedicated to testing in its existing building to better use the facility's infrastructure and engineering. The new building will provide two floors of office space for administrative functions, thereby allowing the company to expand many laboratory areas in the existing building and manage costs. The new building is expected to be complete by August 2009 and will provide needed space for Nelson's growing business.
Madeira Names New Advisor
Madeira Therapeutics (Leawood, KS), a new drug-development company specializing in pediatric pharmaceuticals, named David L. Tousley to its board of advisors. Tousley is currently the principal of Stratium Consulting Services, which assists companies with strategic and financial planning and management.
Tousley has more than 25 years of pharmaceutical-development, financial, and process-management experience. Before joining Madeira's board, Tousley held executive positions at airPharma (Overland Park, KS), PediaMed Pharmaceuticals (Florence, KY), AVAX Technologies (Philadelphia, PA), and Pasteur, Merieux, Connaught (Lyon, France).
FDA Audits Azopharma Facility
Azopharma Product Development Group's (Hollywood, FL) Cyanta Analytical Laboratories facility in Maryland Heights, Missouri, was successfully audited by the US Food and Drug Administration. The audit produced no Form 483s or other major observations.
Cyanta Analytical Laboratories is a member of the Azopharma Product Development Group and provides analytical testing to the pharmaceutical, biotechnology, and medical-device industries. Cyanta is an emerging leading service provider in the development of inhalation devices. The Cyanta facility was previously audited in 2006. The previous audit produced no Form 483s or major observations.
Farr APC Launches New Dust-Collection Website
Farr Air Pollution Control (APC, Jonesboro, AR), a leading producer of industrial dust and fume collectors for manufacturing processes, launched a fully redesigned website at www.farrapc.com. The new site provides viewers with information and easy-to-navigate paths to help guide and simplify dust-collection decisions.
Farr APC dust-collection website.
The site describes Farr's "Gold Series" flagship line of cartridge dust collectors, as well as "HemiPleat" filters and accessories for new and retrofit use on all types of collectors. The site offers features and technical data, downloadable literature, customer-installation photos, and videos. Visitors to the site can also browse Farr's extensive library of educational materials.