BioPharm International, December 2005 - BioPharm International

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BioPharm International, December 2005
Featured Article
Small-scale Biomanufacturing Benefits from Disposable Bioreactors
By Fabrizio Baumann
The cell density achieved in a CELLine bioreactor is typically 1 to 2 orders of magnitude higher than in a conventional culture vessel
Peer-Reviewed Research
Closing Gaps in Quality Control of Electronic Data
By Douglas Bissonnette
All potential uses and supporting endeavors of the data must be examined and then defined as a virtual process stream.
Securing Your Company's Manufacturing Data
By Bryan L. Singer, CISSP
A 2000 cyber crime study revealed that 71 percent of security breaches were caused by people who worked within the company.
Rapid Microbiological Methods and the PAT Initiative
By Jeanne Moldenhauer
PAT can be defined as a collection of real-time data in-line to make decisions about product quality early in the production process.
Resources
Applikon, Inc
Applikon develops, manufactures and supplies bioreactor systems for R&D, pilot plant and production in cell culture and microbial fermentation from 7 mm – 5,000 liter capacities. Recent technology advancements include standard off-the-shelf Allen Bradley, Siemens and Delta V control packages with integrated fieldbus technology.
Baxter Healthcare Corporation
Baxter Healthcare Corporation's BioPharma Solutions business offers proprietary technologies and best in class contract services, addressing outsourcing needs throughout development and commercialization of parenteral (injectable and pulmonary) drugs. The company has partnered with more than 150 clients, working with the top fifteen bio/pharmaceutical companies.
Bio-Rad Laboratories
Bio-Rad Laboratories has remained at the center of scientific discovery for more than 45 years by providing a broad range of innovative tools and services to the life science research and clinical diagnostics markets. The company is world renowned among hospitals, universities, major research institutions, biotechnology, and pharmaceutical firms for its commitment to quality and customer service.
Biotest
Biotest is a leading international provider of top quality controlled environment monitoring instrumentation. Biotest offers the HYCON System – a comprehensive line of environmental monitoring products. The HYCON system includes the Biotest RCS air samplers, which are easy to operate and which, when used with HYCON agar media strips, ensure a secure and accurate sample. Biotest offers battery-operated, handheld, and portable Airborne Particle Counters for the detection of airborne particulate contamination.
Celliance Corporation
Celliance offers an expanding array of bioprocessing products and services including diagnostic products, cell culture media supplements, and contract manufacturing services. The company's customers include many of the leading biopharmaceutical companies worldwide who have brought FDA-approved products to the market using Celliance's products and technologies. Celliance's products help accelerate the movement of critical therapeutic drugs from the laboratory to the marketplace. Celliance is a Serologicals company based in Atlanta, GA.
GE Healthcare Bio-Sciences AB
GE Healthcare, a General Electric company, provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare Bio-Sciences, a business of GE Healthcare, provides a broad range of products and services for protein separation, medical diagnostics, and drug discovery.
HyClone Laboratories, Inc.
HyClone is a business unit within the Fisher Biosciences group, offering leading cell-culture products and bioprocessing systems for life-sciences research and protein-based drug production. Widely known as the premier brand of quality sera for cell culture, HyClone is also a leading brand of classical media, serum-free and protein-free media, process liquids and flexible, single-use BioProcess Container (BPC) systems, which are sterile, disposable bags specifically designed for transporting, mixing, dispensing, and storing sterile liquids and powders.
HyClone Laboratories, Inc.
HyClone is a business unit within the Fisher Biosciences group, offering leading cell-culture products and bioprocessing systems for life-sciences research and protein-based drug production. Widely known as the premier brand of quality sera for cell culture, HyClone is also a leading brand of classical media, serum-free and protein-free media, process liquids and flexible, single-use BioProcess Container (BPC) systems, which are sterile, disposable bags specifically designed for transporting, mixing, dispensing, and storing sterile liquids and powders.
Invitrogen Corporation
Invitrogen Corporation provides products and services that support academic and government research institutions, and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life sciences technologies for disease research, drug discovery, and commercial bioproduction.
Lancaster Laboratories, Inc.
One of the nation's premier testing laboratories, Lancaster Laboratories provides comprehensive analytical services in chemistry and microbiology for a broad spectrum of clients in the pharmaceutical, biopharmaceutical, medical device, and animal health industries.
Mediatech, Inc.
Now in its 22nd year, Mediatech, Inc. is a leading manufacturer and supplier of cell culture and molecular biology reagents. Located in Herndon, Virginia Mediatech was named Virginia Biotechnology Association Company of the Year for 2004. Plans are underway for Mediatech to relocate their corporate headquarters to Innovation@ Prince William Technology Park. Governor Warner (VA) announced that Mediatech would receive state and county cash grants and other incentives in the range of $1.4M for the relocation.
Millipore Corporation
Millipore's technologies are used by most of the world's leading biopharmaceutical companies. We deliver more than advanced filtration, purification and QA/QC products. With Millipore, you have access to services that optimize and validate your processes, resources to streamline and enhance your operation, and unmatched know-how from over 50 years experience.
New Brunswick Scientific
New Brunswick Scientific manufactures equipment for culture growth, detection, and storage, offering a new line of CO2 Incubators, as well as over 30 models of shakers and a full range of fermentors (1 – 3,000 L) and cell culture bioreactors (500 mL – 500 L). The company's large-scale bioprocessing systems are cGMP-compliant, delivered in about 12 weeks, and upgradeable at any time, pre-or post-delivery.
Pall Life Sciences
Pall is a leading global provider of filtration, purification, and separation technologies to the diverse and rapidly expanding life sciences market. Its products are used from the earliest stages of discovery and development of new drugs, through production and delivery of therapies for the prevention, diagnosis, and treatment of disease.
Polymer Laboratories Inc
Polymer Laboratories (PL) specializes in developing and manufacturing high-grade polymeric particles for HPLC columns (nano through process-scale), solid- and solution-phase synthesis supports for high throughput organic synthesis and peptide synthesis; and polymers for clinical diagnostics, including paramagnetic particles for bioseparations.
Quintiles Consulting
Quintiles Consulting provides global regulatory, compliance, and validation consulting services to the pharmaceutical, biologics, and medical device industries. In addition, the company provides product development services to the medical device industry. Quintiles Consulting has helped many pharmaceutical, medical device, and biologics companies successfully meet regulatory requirements as well as their own business objectives.
SAFC Biosciences
SAFC Biosciences is changing the very nature of bioscience. Combining excellent service with world-class science, SAFC Biosciences has developed a way to help biopharmaceutical companies bring products to market faster and accelerate their commercial success.
Sartorius Corporation
Sartorius specializes in the manufacture and support of separation and purification equipment in the pharmaceutical and biotech industries scaleable from R&D to pilot plant to production levels. This covers process, pilot and laboratory filtration systems for pharmaceuticals and biotech industries, including membrane and depth filter cartridges and capsules, fermentors and bioreactors, crossflow micro and ultrafiltration systems, life sciences laboratory devices and cell culture products, SS housings, filter integrity test equipment, filter and bag assemblies and disposable mixing technologies.
Sparta Systems, Inc.
Founded in 1994, Sparta Systems, Inc. is an enterprise software manufacturer that has developed innovative, 21 CFR Part 11 compliant Quality Management System (QMS) software for logging, tracking, reporting, and trending of quality and regulatory areas. Sparta has pioneered QMS and has provided cGxP solutions since 1998. Its product, TrackWise, is a leading QMS solution in the highly regulated life sciences industry, with over 115 accounts, over 250 implementations, and more than 200,000 end-users.
Swagelok Company
Established in 2003, Swagelok Biopharm Services Company (SBSC) is a strategic business unit of Swagelok Company and is dedicated to developing and manufacturing an extensive line of fluid system component technologies for the biopharmaceutical, food, beverage, dairy, and cosmetic industries worldwide. The business unit employs more than 150 associates at four manufacturing and marketing facilities located in North Tonawanda, New York, and Solon, Ohio.
Tosoh Bioscience LLC
Tosoh Bioscience is a major supplier of liquid chromatography products to the pharmaceutical and biotechnology industries. Our products are used for the analysis, isolation, and purification of proteins, peptides, enzymes, nucleic acids, antibiotics, and small molecules. Established in 1987, Tosoh Bioscience became a wholly-owned subsidiary of Tosoh Corporation in 2000.
VTS Consultants, Inc.
VTS Consultants was founded in 1993 and currently employs more than 140 degreed consultants serving the pharmaceutical, biotechnology, and medical devices industries. We are one of the country's largest independently owned consulting companies providing services in the United States, Canada, Europe, Mexico, and the Caribbean.
Xcellerex, Inc.
Xcellerex, Inc. was founded in September 2003 and has established a position of leadership for alternative modular manufacturing facilities and integrated disposable technologies for biomanufacturing.
AppTec
AppTec, a GMP/GLP contract manufacturing and testing company, is a unique single-source for comprehensive GLP/GMP-compliant contract testing, development and cGMP manufacturing services for biopharmaceuticals, cellular therapeutics, medical devices, and tissue-based products.
DSM Pharmaceutical Products
DSM Pharmaceutical Products
Columns and Departments
Psst! Hey Doc...Got a Hot Stock Tip?
By Brian O'Connell
Doctors can charge up to $500 per hour to discuss the pros and cons of clinical drug trials.
From the Editor in Chief: Price and Prejudice
By Laura Bush
You tell me whar a man gits his corn pone, en I'll tell you what his 'pinions is."
Regulatory Beat: FDA Seeks to Ensure Product Quality and Streamline Regulation
By Jill Wechsler
This quality approach to biotech manufacturing may also establish a pathway for approving generic versions of biotech therapies.

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