BioPharm International, December 2006 - BioPharm International

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BioPharm International, December 2006
Features
Quality Control: Operator Error: Is It Really the Root Cause of Performance Problems?
By Vivian Bringslimark
Conducting an analysis of the 4 Ms—man, machine, methods, and materials—enables companies to identify the true root causes of deviations.
Outsourcing: Offshoring to China: What Should Your Model Be?
By Jean-Francois Denault
Offshoring to China has captured the imagination of Western managers seeking to reduce operating costs. What is the best approach?
Analytical Methods: A Statistical Perspective on the ICH Q2A and Q2B Guidelines for Validation of Analytical Methods
By Steven Walfish
Vagueness in the ICH Q2A and Q2B guidelines necessitates effective protocol design and data analysis. For specificity (detection in the presence of interfering substances), the goal is statistical differences with meaningful implications on assay performance. Linearity (results directly proportional to concentration of analyte in the sample) is typically demonstrated via least squares regression. Accuracy (difference between measured and true values) usually is presented as a percent of nominal. Precision analysis is vital because it supports claims of accuracy and linearity. A well-designed experiment and statistically relevant methods will facilitate method validation in accordance with ICH guidelines.
Columns and Departments
From the Editor: The Stem Cell Vote
By Laura Bush
In various races in the November elections, voters supported stem cell research. Now, will they prepared to fund it?
Street Talk: Stem Cells: Tough Sell on Wall Street?
By Brian O'Connell
There are 72 maladies for which human patients have received some benefit from adult stem cell interventions.
Final Word: New Organization Forms to Help FDA Fulfill its Mission
By James Greenwood
A key to bolstering FDA and its mission is securing balanced and consistent funding.
Regulatory Beat: Campaign Heats Up for Follow-On Biologics
By Jill Wechsler
The prospect of any cost savings has been fueling efforts to establish a pathway for follow-on biopharmaceuticals.
Operations Excellence: The First Operational Roadmap for The Biopharmaceutical Industry
By Marc Puich
Recently, 22 vice presidents of biopharmaceutical operations met in Boston to develop the first operational roadmap for their industry. This special executive-level consortium was organized to discuss two key questions.
Corporate Capabilities
Aptuit
Aptuit is a company focused on streamlining and supporting the drug development process for biotechnology and pharmaceutical innovators. We are engineering a better drug development process by delivering critical expertise, technologies, facilities, ideas, and services in a seamless and globally integrated offering.
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.
Laureate Pharma, Inc.
Laureate Pharma, Inc. is a full service contract manufacturing organization (CMO) with headquarters in Princeton, NJ. The company is dedicated to supporting the development and commercialization of pharmaceutical products for pharmaceutical and biopharmaceutical companies.
Maxim
Maxim offers contact memory products called iButtons. Our Thermochron and Hygrochron iButtons are small digital temperature and humidity data loggers. They are used in the pharmaceutical, biotech, and medical device industries for cold chain monitoring and QA/QC applications in labs and manufacturing facilities.
Blue Mountain Quality Resources
Blue Mountain Quality Resources has been developing technologically advanced software applications for FDA-regulated biotech companies for over 15 years. The company offers complete solutions ranging from single-site software implementation, training and validation, to global, multisite turnkey packages. Designed for how work is done, these solutions improve compliance and enhance productivity with built-in flexibility to satisfy the needs of individual biotech companies.
Baxter Healthcare Corporation
Baxter Healthcare Corporation's BioPharma Solutions business offers proprietary technologies and 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 15 biopharmaceutical companies.
GE Healthcare
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.
BioConvergence
BioConvergence is a contract service provider offering cGLP parenteral product development, cGMP materials management including cold chain storage, and consulting services to the pharmaceutical industry. Our e-transparency solution, which is the first of its kind, provides clients real-time secure access to their data found in our research scientists' laboratory notebooks, ERP material transactions and SOPs.
Lancaster Laboratories, Inc.
Lancaster Laboratories provides analytical services in chemistry and microbiology for a broad spectrum of clients in the pharmaceutical, biopharmaceutical, medical device, and animal health industries. For 45 years, we have delivered laboratory services with strict regulatory compliance and close attention to our clients' project needs. Each project has an assigned project team, including scientists and a client service representative. With a large laboratory capacity, extensive technical expertise, and a multiple-shift staff, we can handle projects of any size.
ATMI LifeSciences
Since 1986, ATMI LifeSciences has been developing and manufacturing single-use solutions for the BioPharmaceutical and Microelectronics industries with additive-free resins, our own in-house extruded film, and manufacturing our product in Class 100 cleanrooms.
PAA—The Cell Culture Company
PAA Laboratories, founded in February 1988, specializes in the manufacture and worldwide distribution of cell culture products for research, development, diagnostic and biopharmaceutical production.
AppTec
AppTec, a GMP/GLP contract manufacturing and testing company offers GLP/GMP-compliant contract testing, development, and cGMP manufacturing services for biopharmaceuticals, cellular therapeutics, medical devices, and also tissue-based products.
Florida Biologix
Florida Biologix is a nonprofit contract manufacturing and testing organization whose primary focus is cGMP compliant production of Phase 1 and 2 clinical trial material on time and at reasonable prices. Our senior cGMP manufacturing, Quality Control and Quality Assurance managers have over 90 years of combined biopharmaceutical manufacturing experience. Our operational model, location, and affiliations help to keep costs low.
Tosoh Bioscience
Tosoh Bioscience is a 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.
SGS Life Science Services
SGS is a verification testing, inspection, and certification company. SGS Life Science Services is a contract service organization providing clinical research services and quality control testing.
Xcellerex, Inc.
Xcellerex is a technology integration company offering disposable technologies and contract manufacturing services to the biopharmaceutical industry.
Biotest
Biotest is a provider of 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. When used with HYCON agar media strips, they help ensure a secure and accurate sample. Battery-operated, handheld, and portable Airborne Particle Counters are offered for the detection of airborne particulate contamination. For surface sampling, Biotest Contact Slides are used for curved surfaces and come in self-contained packaging to prevent secondary contamination.
Cambrex
The Cambrex business unit, comprising the two sites—Cambrex Baltimore and Cambrex Hopkinton—provides dedicated process development, analytical and cGMP manufacturing services for the manufacturing of bulk active pharmaceutical ingredients. With our extensive experience in scale-up and commercial manufacturing of recombinant proteins, vaccines and plasmid DNA, we can help accelerate your timelines through a fully integrated approach from development through pilot and mid-scale manufacturing of clinical materials. Our services include fermentation and recovery of products from microbial systems and we have expertise in recovery, purification and analytical tools to design and optimize your product yields.
Cytovance Biologics LLC
Cytovance Biologics helps companies developing biopharmaceutical products derived from mammalian cell culture to move their products rapidly and cost-effectively into and through clinical development. We offer a comprehensive portfolio of process development, cGMP cell banking and cGMP manufacturing services under reasonable business terms that have been developed based on our strong client-side experience and intimate knowledge of the technical and business challenges facing companies developing antibody and recombinant glycoprotein products.
Microbix Biosystems, Inc.
Microbix Biosystems, Inc. specializes in developing proprietary biological technologies which have led to the development of a pipeline of products and services in three areas; biotherapeutics, vaccines and non-therapeutic biologics. Each product area utilizes the company's core technology platform based on cell biology, purification and characterization of viruses and proteins.
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 Systems (QMS) software for logging, tracking, reporting, and trending regulatory, commercial and operational regulatory requirements.
SAFC Biosciences
SAFC Biosciences supplies critical raw materials, providing companies using cell culture-based manufacturing with a wide range of customized products and services as and when they need them. Its depth of expertise, technical support and responsiveness means customers benefit from reliable resources.
Millipore Corporation
Delivering more than filtration, purification and process monitoring products, Millipore Corporation provides access to services that optimize and validate your processes, resources to streamline your operation, know-how from over 50 years' industry experience, and solutions that integrate it all.
Cyanta Drug Development Services
Cyanta Drug Development Services is solely dedicated to assisting pharmaceutical, biotechnology and medical device companies achieve their regulatory registration goals through extensive analytical testing and support services. The spin of Chemir Analytical Services' pharmaceutical group, we are outfitting a new facility with state-of the-art instrumentation and systems to continue to meet expectations of compliance and timely service. Our background of solving challenging analytical problems and providing drug development services has enabled us to become a premiere drug development partner.
Polymer Laboratories, Varian, Inc.
Polymer Laboratories (PL), now a part of Varian, Inc., specializes in the development and manufacture of high grade polymeric particles for HPLC columns, nano through process, solid and solution phase synthesis supports for high throughput organic synthesis and peptide synthesis, and polymers for clinical diagnostics, including paramagnetic particles for bioseparations.
Eden Biodesign
Eden Biodesign is a biologics contract manufacturer and fully integrated biopharmaceutical development organization whose role is to design, develop and deliver valuable biopharmaceutical medicines.
Asahi Kasei Medical America, Inc.
Asahi Kasei Medical America,Inc., develops Planova filters, which are designed specifically for virus removal. Used in commercial processes since 1989, Planova filters significantly enhance safety in biopharmaceuticals and plasma-derived therapeutics. Asahi Kasei Medical America supplies Planova virus removal filters to biopharmaceutical companies worldwide. In particular, the USA Long Island branch of Asahi Kasei Medical America is responsible for the support of Planova activities in biopharmaceutical companies in USA and Canada.
Bio-Rad Laboratories
Bio-Rad Laboratories provides a broad range of tools and services to the life science research and clinical diagnostics markets. The company is known among hospitals, universities, major research institutions, biotechnology, and pharmaceutical firms for its commitment to quality and customer service. It has built strong customer relationships that advance research and development efforts and support the commercialization of new technology, especially in the high-growth fields of genomics, proteomics, biopharmaceutical discovery, food safety, and biotechnology education. Bio-Rad delivers scientific solutions to more than 70,000 customers in more than 70 countries.

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