Biopharm International back issues from December 1999:
Prologue to development
Dec 01, 1999; ... When BioPharm magazine was launched in the fall of 1987 (as BioPharm Manufacturing), only seven approved biotechnology drugs (biopharmaceuticals) were on the market. By late 1998, 54 such medicines were on the market, and 350 more were in development. Biotechnology products were being tested by ...
Preclinical development
Dec 01, 1999; ... Description Once a therapeutic molecule has been identified, discovered, or designed - and once it has shown real promise through screening activities, functional genomics, and/or proteomics (the drug discovery phase) - it goes into development. The ultimate goal is large-scale ...
The IND
Dec 01, 1999; ... In its investigational new drug (IND) app(ication, a company files a request with FDA to expose human volunteers and patients with the disease under study to its experimental drug. Companies cannot administer drugs to humans without FDA authorization to do so. The IND is an ongoing file at FDA, ...
Phase I clinical development
Dec 01, 1999; ... Time: about one year cost: $100,000-$1,000,000 Scale: grams of product Description A small-scale Phase I trial may begin within 30 days of a biopharmaceutical company's filing its IND (see previous chapter), unless FDA places a hold on the study - based on evidence of ...
Phase II clinical development
Dec 01, 1999; ... Time: 1-2 years Cosh $10-100 million Scale. grams of product Description Phase 11 clinical studies evaluate a drug's efficacy and look for side effects in 100-300 patient volunteers. The data they provide are used to characterize the relationship between dosage and ...
Phase III clinical development
Dec 01, 1999; ... Time: 2-4 years Cost: $10-500 million Scale: kilograms of product Description During Phase III trials, the company verifies the efficacy of its drug and monitors 1,000-3,000 patient volunteers for adverse events during long-term use. Less than a quarter of INDs make it ...
The BLA
Dec 01, 1999; ... A biologics license application (BLA) is a request to market a new biologic product. The BLA is a new requirement: As of 1996, anyone who manufactures biopharmaceuticals for interstate commerce in the United States must hold a BLA, issued by FDA's Center for Biologics Evaluation and Research ...
Phase IV and beyond
Dec 01, 1999; ... Time: indefinite Cost: varied Scale: kilograms to tons of products Description Less than a fifth of all IND drugs go on to earn marketing approval. FDA may require Phase IV studies to evaluate a drug's longterm effects. In addition, once products are on the ...
A holiday treat
Dec 01, 1999; ... Whether this is your first issue of BioPharm or you are a seasoned reader, the 1999 Corporate Capabilities issue provides you with quite a treat. Since 1994, BioPharm has dedicated its December issue to the Corporate Capabilities format. This format provides you with a unique opportunity to ...
AMRESCO Inc.
Dec 01, 1999; ... Description AMRESCO is a chemical company dedicated to supplying standard and custom products to its vast customer base. As regulated by FDA for in vitro diagnostic manufacturing and handling of pharmaceutical intermediates, AMRESCO has the infrastructure to satisfy a wide range of ...
Amersham Pharmacia Biotech
Dec 01, 1999; ... Description Amersham Pharmacia Biotech is a major international biotechnology company,- it provides innovative and leading-edge technological solutions to the problems faced by researchers aiming to discover and produce new drugs and therapies, faster and more cost-effectively than ever ...
Beckman Coulter, Inc.
Dec 01, 1999; ... Description Beckman Coulter, Inc., is a leading provider of instrument systems and complementary products that simplify and automate processes in life science and clinical laboratories. The company's products are used throughout the world in all phases of the battle against disease, ...
BioPharm
Dec 01, 1999; ... Description BioPharm magazine, beginning its 13th year of publication in 2000, provides practical information to readers involved in developing and manufacturing pharmaceutical products through biotechnology. Its 20,000+ U.S. and western European readers are involved in research and ...
BioReliance
Dec 01, 1999; ... Description BioReliance, founded in 1947 as Microbiological Associates, is a contract service organization providing regulatory-compliant biological testing and manufacturing services to pharmaceutical, biopharmaceutical, medical device, and chemical companies worldwide. In October ...
Bio Science Contract Production Corp.
Dec 01, 1999; ... Description Bio Science Contract Production Corp. is a premier provider of contract process development and CGMP production services to biopharmaceutical companies. The primary goal of its production team is consistent batch production. The company's scientists, engineers, and ...
BioWhittaker, Inc.
Dec 01, 1999; ... BioWhittaker, Inc. A Cambrex Company 8830 Biggs Ford Road Walkersville, MO 21793, USA Tel: (301) 898-7025 Toll Free: (800) 638-8174 Fax: (301) 845-8338 www.biowhittaker.com BioWhittaker Europe s.p.r.l. Pam ...
Boehringer Ingelheim GmbH
Dec 01, 1999; ... Description Boehringer Ingelheim is one of the most successful pharmaceutical companies in research and development, manufacturing, and worldwide registration and marketing of biopharmaceutical products. With two development and production sites, Boehringer Ingelheim produces ...
Carbohydrate research
Dec 01, 1999; ... Description Carbohydrate Research is a global provider of contract and collaborative R&D services for the development of new human health care products. Carbohydrate Research also supplies specialty chemicals and intermediates to biotechnology and biopharmaceutical companies ....
Charles River Endosafe
Dec 01, 1999; ... Charles River Endosafe 1023 Wappoo Road Suite 43-B Charleston, SC 29407 Tel: (800) 762-7016 (843) 766-7575 Fax: (843) 766-7576 www.endosafe.com endo-comments@criver.com Founded:1987 Description Endosafe was founded in 1987 by James F. Cooper, a pioneer in the field of Limulus ...
Charles River Tektagen
Dec 01, 1999; ... Description Charles River Tektagen is a contract testing company that supplies a full range of biosafety and analytical testing services to support the development and commercialization of biopharmaceutical products. Since 1987, Charles River Tektagen has built its reputation on ...
Charles River SPAFAS
Dec 01, 1999; ... Charles River SPAFAS Corporate Office 190 Route 165 Preston, CT 06365 Tel: (800) SPAFAS1 (860) 889-1389 Fax: (860) 889-1991 Laboratory 67 Baxter Road Storrs, CT 06268 Tel: (860) 429-1990 Fax: (860) ...
Chesapeake Biological Laboratories, Inc.
Dec 01, 1999; ... Description CBL, established in 1980, is a recognized leader in the development and production of sterile biopharmaceutical, pharmaceutical, and generic injectables. Through the formation of a strategic partnership with its clients, CBL serves as the single source for service, from ...
Collaborative Group, Ltd.
Dec 01, 1999; ... Description The Collaborative Group comprises three companies: Collaborative Laboratories, Inc. (CL), Clear Solutions Biotech, Inc. (CSB), and Collaborative BioAlliance, Inc, (CBA), which provide an integrated approach to the pharmaceutical and personal care industries. The founding ...
Covance Inc.
Dec 01, 1999; ... Covance Inc. 210 Carnegie Center Princeton, NJ 08540-6233 Tel: (888) COVANCE Fax: (609) 514-1986 www.covance.com Founded:1997 Description Covance, with headquarters in Princeton, NJ, is a leading pharmaceutical services ...
DSM Biologics Company Inc.
Dec 01, 1999; ... Description DSM Biologics (formerly known as Gist-brocades/ Bio-Intermediair) is a business unit of DSM Fine Chemicals (part of the DSM Life Science Products cluster). DSM Fine Chemicals is a supplier of choice for innovative large pharma houses, based on its superior technology ...
Ertel Engineering Company
Dec 01, 1999; ... Ertel Engineering company PO Box 3358 Kingdon, NY 12402 Tel: (800) 553-7835 (914) 331-4552 Fax: (914) 339-1063 www.ertelengineering.com sales@ertelengineering.com Description Ertel Engineering Company was founded in 1932. At ...
Hong Kong Institute of Biotechnology Ltd.
Dec 01, 1999; ... Description The Hong Kong Institute of Biotechnology Ltd, (HKIB) was founded in 1988. Its primary role is to take the lead in establishing a downstream processing development center for biotechnology products in Hong Kong and the Asia-Pacific region. It is the institute's philosophy to ...
Hurley Consulting Associates Ltd.
Dec 01, 1999; ... Company Description Hurley Consulting Associates Ltd. is a leading international consulting and contract research company serving the health sciences industry. With offices in Chatham, NJ, and Basel, Switzerland, Hurley Consulting Associates Ltd. has more than sixty employees, including ...
HyClone
Dec 01, 1999; ... Description HyClone is a world leader in the development, manufacture, and supply of cell culture sera, media (standard, serum-free, protein-free, and custom), and reagents, in small volumes for research purposes, in large volumes for biopharmaceutical production demands, and in ...
IDEC Pharmaceuticals Corporation
Dec 01, 1999; ... IDEC Pharmaceuticals Corporation 11011 Torreyana Road San Diego, CA 92121 Tel: (858) 431-8500 Fax: (858) 431-8750 idecmfg@idecpharm.com www.idecmfg.com Description IDEC's experienced people make the difference." The company's success in rapid ...
Integrated Protein Technologies
Dec 01, 1999; ... Description Integrated Protein Technologies (IPT), a unit of Monsanto Company, has developed and is commercializing the use of transgenic plants as effective production systems to manufacture therapeutic monoclonal antibodies (MAbs) and other therapeutic proteins for the biotechnology ...
JRH Biosciences
Dec 01, 1999; ... Description JRH Biosciences (a CSL company) manufactures a full range of cell culture products for use in the global discovery, development, scale-up, licensing, and manufacturing of vaccine and therapeutics. The companies have become industry leaders by providing innovative, reliable ...
Kendro Laboratory Products
Dec 01, 1999; ... Description Kendro Laboratory Products is a worldwide company formed by the merger of Heraeus Instruments and Sorvall Products. The company manufactures a wide range of Sorvall and Heraeus brand products for the pharmaceutical, biotechnology, clinical, health care, and blood processinq ...
KMI/PAREXEL, Inc.
Dec 01, 1999; ... KMI/PAREXEL, Inc. 375 Concord Avenue Belmont, MA 02478 ToL (617) 484-9920 Fax: (617) 484-9068 www.kminc.com info@belmont.kminc.com Employees: 150 Founded:1989 Description KMI/PAREXEL, Inc., is a world leader offering advanced compliance, validation, and information services to ...
Life Technologies, Inc.
Dec 01, 1999; ... Description Life Technologies, Inc., provides essential technologies for the science of life. The company offers technical expertise, technology licensing, research services, large-scale production, and custom and catalog products of virtually every description at a level that is unique ...
Lampire Biological Laboratories, Inc.
Dec 01, 1999; ... Description Founded in 1977, Lampire Biological Laboratories, Inc., is an international supplier of antibodies, reagents, animal blood products, and custom antisera production services. The company has grown to more than 60 professionals offering expertise in bioreactor and cell culture ...
Marathon Biopharmaceuticals
Dec 01, 1999; ... Description Marathon Biopharmaceuticals is a dedicated fullservice CGMP contract manufacturing company. Marathon offers a variety of services to its clients including fermentation, purification, process development, scale-up, and small-scale fill-and-- finish. Marathon provides ...
MDS Panlabs
Dec 01, 1999; ... MDS Panlabs An MDS Pharmaceutical Services Company 11804 North Creek Parkway South Bothell, WA 98011-8890 Tel: (800) 487-9161 (425) 487-8200 Fax: (425) 487-3787 www.panlabs.com panlabs@panlabs.com Founded:1970 Description Panlabs Biosafety, a division of Seattle-based VIDS ...
Mediatech, Inc.
Dec 01, 1999; ... Description Mediatech manufactures and distributes cell culture media, supplements, and other sterile solutions. The company maintains a sales organization of more than 20 representatives. There is a strong orientation to partner with clients and develop proprietary products that ...
Millipore BioProcess Division
Dec 01, 1999; ... Description Millipore is a multinational company supplying membrane-based and chromatographic purification products and services for R&D, scale-up, and manufacturing applications to pharmaceutical and biotechnology companies worldwide. Millipore is dedicated to total quality ...
Molecular Medicine, LLC
Dec 01, 1999; ... Description Molecular Medicine is a contract development and manufacturing company dedicated to the production of cell- and gene-based therapeutics. Ajoint venture between Roche and University of California, San Diego, Molecular Medicine's mission is to assist its clients in initiating ...
New Brunswick Scientific Co., Inc.
Dec 01, 1999; ... DescrIption New Brunswick Scientific (NBS) manufactures equipment used for the growth, measurement, and recovery of cells and their by-products. Though best known for the legendary durability of its New Brunswick Shaker, NBS also offers standard and custom-designed fermentors and ...
One Cell Systems, Inc.
Dec 01, 1999; ... One Coll Systems, Inc. 100 Inman Street Cambridge, MA 02139 Tel: (617) 868-2399 Fax: (617) 492-7921 www.onecell.com inforequest@onecell.com Description One Cell Systems, Inc., develops, manufactures, and markets research products and services based on its proprietary Gel ...
optek-Danulat, Inc.
Dec 01, 1999; ... Description: Founded in Germany in 1984, optek-Danulat has made huge strides in providing reliable, high quality in-line sensor systems to control liquid processes for the most exacting and demanding applications. Using photometry to measure absorption and scattered-light in the ...
Pharmaceutical Devleopment Center
Dec 01, 1999; ... Description Pharmaceutical Development Center (PDC) offers a full range of pharmaceutical development and production services. Facilities include GMPmaintained areas for manufacture of sterile and nonsterile dosage forms and complete analytical and microbiological laboratories. A staff ...
Pall Corporation
Dec 01, 1999; ... Description Pall Corporation is a specialty materials and engineering company with the broadest-based filtration and separations capabilities in the world. It serves a diverse, global customer base in three major markets: health care, aeropower, and fluid processing. The company's ...
pAlliance
Dec 01, 1999; ... pAlliance 28159 Avenue Stanford Valencia, CA 91355 Tel: (800) 362-7737 Fax: (800) 718-2056 QIAGEN GmbH Max-Volmer-StraBe 4 40724 Hilden Germany Tel: +49-2103-892-240 www.qiagen.com Description The new force in contract plasmid DNA manufacturing, pAlliance ...
Phoenix International Life Sciences, Inc.
Dec 01, 1999; ... Description One of the five largest contract research organizations (CROs) in the world, Phoenix International Life Sciences provides drug development services to the pharmaceutical, generic drug, and biotechnology industries. Operations in North America, major European countries, South ...
Polymer Laboratories Inc.
Dec 01, 1999; ... Description Polymer Laboratories (PL) specializes in the development and manufacture of polymeric particles for use as chromatographic media, resins for combinatorial chemistry and peptide synthesis, latex particles for clinical diagnostics, and polymers for pharmaceutical applications ....
Primedica Corporation
Dec 01, 1999; ... Description Primedica Corporation is a leading international contract research organization, delivering nonclinical development services in an effort to meet its clients' product development needs. Primedica's more than 500 employees play a critical role in the commercial development of ...
Quintiles Transnational Corp.
Dec 01, 1999; ... Description Quintiles Transnational Corp. has been described as "healthcare knowledge in motion." The company is the world's only global cross-discipline resource providing a complete portfolio of health care product development, commercialization, and information solutions. Named to ...
Q-One Biotech Ltd.
Dec 01, 1999; ... Description Q-One Biotech provides specialist safety testing services, CGMP contract manufacturing of cell banks, and gene therapy products and process validation services to the biopharmaceutical industry. The company provides the level of quality, technical, and regulatory support ...
Ricerca, Inc.
Dec 01, 1999; ... Ricerca, Inc. 7528 Auburn Rd. Painesville, OH 44077 Tel: (888) md4rxs (440) 357-3300 Fax: (440) 354-"15 www.Ricerca.com pharm@ricerca.com Employees: 240+ Founded:1986 Description Ricerca is an independent ...
Sigma-Aldrich
Dec 01, 1999; ... Description Sigma-Aldrich, headquartered in St. Louis, MO, is the world's leading supplier of research products and services for the life science market. It is also a major global supplier of biochemicals for the pharmaceutical and biotechnology industries. Sigma-Aldrich offers ...
SmithKline Beecham Biopharmaceuticals
Dec 01, 1999; ... Description SmithKline Beecham Biopharmaceuticals, a business unit of SmithKline Beecham Pharmaceuticals, provides contract manufacturing services focused on the preparation of bulk biopharmaceuticals derived from mammalian cell culture. This unit is a full-service partner in the ...
Swagelok Company
Dec 01, 1999; ... Description Swagelok entered the biopharmaceutical market with one goal: To support customers' new discoveries and products with the best sanitary fitting and valve technology available. For more than 50 years, Swagelok products have performed successfully in a variety of ...
TosoHaas
Dec 01, 1999; ... TosoHaas 156 Keystone Drive Montgomeryville, PA 18936 Tel: (800) 366-4875 (215) 283-5000 Fax: (215) 283-5035 www.tosohaas.com tosohaas-direct@rohmhaas.com Founded:1987 Description TosoHaas is a major supplier of liquid chromatography products to the pharmaceutical and ...
USFilter
Dec 01, 1999; ... Description USFilter is a subsidiary of Paris-based Vivendi and is the leading global provider of commercial, industrial, municipal, and residential water and wastewater treatment systems, products, and services with operations in more than 100 countries. USFilter provides total water ...