http://biopharminternational.findpharma.com/biopharm Peer-reviewed technical articles, multimedia, and news on bioprocessing methods, regulatory compliance, and business strategies related to the development and manufacture of biotechnology-based drugs. 2008-08-21T05:59:08Z http://biopharminternational.findpharma.com/biopharm/Whitepapers/Final-Bulk-Inspection-of-Solid-Dose-Pharmaceutical/ArticleStandard/Article/detail/543458?ref=25 Final bulk inspection of solid-dose OTC and regulated pharmaceuticals must deliver consistently high product quality. Customers scrutinize products closely, and processes are increasingly coming under the review of regulatory agencies. Advanced technology addresses these challenges, as new automated continuous inspection systems are more effective and commercially viable than ever before. 2008-08-20T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342008/543458null REMOTE http://biopharminternational.findpharma.com/biopharm/News/Chemists-Developing-Fully-Synthetic-Form-of-Hepari/ArticleStandard/Article/detail/542860?ref=25 Chemists are reporting a major advance toward developing a safer, fully-synthetic version of heparin, the widely used blood thinner currently produced from pig intestines. 2008-08-18T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342008/542860null HTML http://biopharminternational.findpharma.com/biopharm/News/Genentech-Rejects-Roche-Proposal/ArticleStandard/Article/detail/542309?ref=25 The American biotech giant Genentech, Inc. has rejected an offer by the Swiss drug-maker Roche to acquire the 44% of Genentech it does not already own, but said it would be willing to consider a higher bid. 2008-08-14T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/542309null HTML http://biopharminternational.findpharma.com/biopharm/Eric-Langer-Joins-Editorial-Advisory-Board-of-emBi/ArticleStandard/Article/detail/535292?ref=25 Eric S. Langer, president and managing partner at BioPlan Associates, Inc. (Rockville, MD) has joined the Editorial Advisory Board of BioPharm International. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535292null HTML http://biopharminternational.findpharma.com/biopharm/Gail-Sofer-emBioPharmem-EAB-Member-Retires-from-GE/ArticleStandard/Article/detail/535291?ref=25 Gail Sofer, a member of BioPharm International’s Editorial Advisory Board, has retired from her position as director of regulatory compliance at GE Healthcare. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535291null HTML http://biopharminternational.findpharma.com/biopharm/News/Pfizer-to-Close-Manufacturing-Plant-in-Ireland/ArticleStandard/Article/detail/535285?ref=25 Pfizer (New York, NY) has announced plans to close its manufacturing plant located at Little Island, Ireland, after a failed attempt to find a buyer for the facility. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535285null HTML http://biopharminternational.findpharma.com/biopharm/Roche-Acquires-Arius-Gains-Access-to-Antibody-Ther/ArticleStandard/Article/detail/535287?ref=25 Roche (Basel, Switzerland) will acquire Arius Research Inc. (Toronto, Canada) in an all-cash transaction for approximately $190 million. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535287null HTML http://biopharminternational.findpharma.com/biopharm/News/Determining-Critical-Quality-Attributes-Forms-the-/ArticleStandard/Article/detail/541703?ref=25 Since the principles of Quality by Design (QbD) for pharmaceutical manufacturing first emerged a few years ago, many companies have been struggling to understand the key concept of design space?what it is exactly, and how to establish it. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/541703null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Launches-Fellowship-Program-to-Develop-Pipelin/ArticleStandard/Article/detail/535286?ref=25 The US Food and Drug Administration is launching a two-year fellowship program aimed at attracting scientists, engineers, and health professionals to the agency. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535286null HTML http://biopharminternational.findpharma.com/biopharm/GeoVax-Partners-with-Vivalis-for-Using-EBx-Technol/ArticleStandard/Article/detail/535364?ref=25 GeoVax Labs, Inc. (Atlanta, GA) and Vivalis (Nantes, France) have signed a letter of intent (LOI) for joint collaboration and commercial license using Vivalis’s EBx technology to manufacture the MVA component of GeoVax’s HIV-1 vaccine. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535364null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Issues-Six-Draft-Guidance-Documents/ArticleStandard/Article/detail/535283?ref=25 On August 6, the FDA released a guidance entitled Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535283null HTML http://biopharminternational.findpharma.com/biopharm/Cobrabio-and-ViroMed-Join-Together-for-RampD-Bioma/ArticleStandard/Article/detail/535289?ref=25 Cobra Biomanufacturing Plc (Keele, UK), a manufacturer of biopharmaceuticals, has extended its manufacturing agreement and intends to form a joint venture with ViroMed Co. Ltd. (Seoul, Korea), a specialist in the development of DNA and protein-based therapeutics. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535289null HTML http://biopharminternational.findpharma.com/biopharm/News/HHS-and-DHS-Announce-Guidance-on-Pandemic-Vaccinat/ArticleStandard/Article/detail/535359?ref=25 The US Departments of Health and Human Services (HHS) and Homeland Security (DHS) have released guidance on allocating and targeting pandemic influenza vaccine. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535359null HTML http://biopharminternational.findpharma.com/biopharm/Florida-Biologix-Signs-cGMP-Agreement-with-Nationa/ArticleStandard/Article/detail/535288?ref=25 Florida Biologix (Alachua, FL), a biopharmaceutical development and contract manufacturing organization, has entered into a current good manufacturing practices (cGMP) manufacturing agreement with the National Taiwan University Hospital (Taipei, Taiwan). 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535288null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-2008ndash2009-Flu-Vaccines/ArticleStandard/Article/detail/535356?ref=25 The US Food and Drug Administration has approved this year’s seasonal influenza vaccines that include new strains of the virus likely to cause the flu in the US during the 2008–2009 season. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535356null HTML http://biopharminternational.findpharma.com/biopharm/Denny-Kraichely-Joins-Editorial-Advisory-Board-of-/ArticleStandard/Article/detail/535290?ref=25 Denny Kraichely, PhD, principal research scientist and group leader of pharmaceutical development and marketed product support at Centocor R&D, Inc. (Radnor, PA), a Johnson & Johnson Company, has joined the Editorial Advisory Board of BioPharm International. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535290null HTML http://biopharminternational.findpharma.com/biopharm/Bridge-Laboratories-to-Build-Second-Facility-in-Be/ArticleStandard/Article/detail/535284?ref=25 Bridge Laboratories (Gaithersburg, MD), a preclinical contract research organization, will build its second preclinical facility in China. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535284null HTML http://biopharminternational.findpharma.com/biopharm/News/ImClone-Board-Opposes-Bristol-Myers-Offer/ArticleStandard/Article/detail/533951?ref=25 Biotechnology firm ImClone has responded to the offer that it received from Bristol-Myers Squibb for a buyout, saying it would review the deal but its initial view is that the bid is much too low. 2008-08-05T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/322008/533951null HTML http://biopharminternational.findpharma.com/biopharm/News/Bristol-Myers-Offers-45-Billion-for-ImClone/ArticleStandard/Article/detail/533632?ref=25 Bristol-Myers Squibb has proposed to acquire its cancer drug partner ImClone Systems in an all-cash deal worth around $4.5 billion. 2008-08-04T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/322008/533632null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Directs-Amgen-to-Revise-ESA-Labeling/ArticleStandard/Article/detail/533649?ref=25 The FDA has ordered Amgen and Johnson & Johnson to make safety-related changes to the labeling of their erythropoeisis-stimulating agents (ESAs), Aransesp and Procrit. 2008-08-04T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/322008/533649null HTML http://biopharminternational.findpharma.com/biopharm/Expansion+%26+Management+Articles/Connecting-the-Manufacturing-Process-to-Patient-We/ArticleStandard/Article/detail/532062?ref=25 Manufacturers of biopharmaceuticals can improve productivity by taking patient wellness into account. 2008-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312008/532062null XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/GMPs-in-Phase-1-Take-2/ArticleStandard/Article/detail/532049?ref=25 GMPs in Phase 1 is more important now than ever before. 2008-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312008/532049null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/Disposables-Open-Up-Possibilities-in-Facility-Desi/ArticleStandard/Article/detail/532051?ref=25 In addition to making technical developments, vendors are also looking at ways to improve supply-chain security. By offering standard, off-the-shelf products, vendors are able to shorten lead times and improve the security of supply. 2008-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312008/532051null XML http://biopharminternational.findpharma.com/biopharm/Fermentation+%26+Cell+Culture+Articles/Modeling-of-Biopharmaceutical-Processes-Part-2-Pro/ArticleStandard/Article/detail/532052?ref=25 A review of some recent contributions in process chromatography. 2008-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312008/532052/Fermentation_cell_culture_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/India+Today/The-Visible-Hand-Government-Supports-the-Biopharma/ArticleStandard/Article/detail/532050?ref=25 What the Indian government is doing to make its biotech sector as strong as its IT sector. 2008-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312008/532050null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Beat/FDA-Seeks-Active-System-for-Monitoring-Adverse-Eve/ArticleStandard/Article/detail/532060?ref=25 The Sentinel System aims to generate more adverse event reporting by health professionals, to analyze health information more effectively, and to enhance FDA methods for communicating new safety information to providers and patients. 2008-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312008/532060null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/A-Rational-Approach-for-Setting-amp-Maintaining-Sp/ArticleStandard/Article/detail/532061?ref=25 Set limits to provide incentives for process improvements. 2008-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312008/532061/0708_microbiology_lab_Wyeth_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/June-2008-BPA-Statement/ArticleStandard/Article/detail/532992?ref=25 BioPharm June 2008 BPA Statement 2008-07-31T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312008/532992null PDF http://biopharminternational.findpharma.com/biopharm/News/Genentech-Reviews-Roche-Proposal/ArticleStandard/Article/detail/531858?ref=25 Genentech, Inc., (South San Francisco, CA) has formed a special committee of its Board of Directors to assess the proposal from the Swiss drug-maker Roche (Basel, Switzerland) to take over the remaining shares of the American biotech giant. 2008-07-25T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/302008/531858null HTML http://biopharminternational.findpharma.com/biopharm/News/Medicare-Drug-Coverage-Under-Fire/ArticleStandard/Article/detail/530669?ref=25 Enough Republicans sided with Democrats last month to approve legislation canceling a scheduled 10.6% cut in Medicare fees for physicians. In doing so, the legislators tacked on dozens of provisions pleasing to beneficiaries and providers alike. 2008-07-18T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/292008/530669null HTML http://biopharminternational.findpharma.com/biopharm/News/Broken-Vials-of-Herceptin-May-Lead-to-Loss-in-Ster/ArticleStandard/Article/detail/529207?ref=25 Genentech (South San Francisco, CA) has informed healthcare professionals that an increased number of complaints have been received regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent. 2008-07-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/529207null HTML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/FDA-Launches-E-Filing-Initiative/ArticleStandard/Article/detail/529021?ref=25 The FDA is launching a pilot program to allow manufacturers to electronically file drug establishment registration and drug listing information, such as ingredients, labeling, and manufacturing information. 2008-07-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/529021null HTML http://biopharminternational.findpharma.com/biopharm/News/Roche-Introduces-Program-to-Facilitate-Corporate-P/ArticleStandard/Article/detail/528612?ref=25 Roche (Nutley, NJ) has introduced a flexible purchase program that will allow US businesses to maintain access to their own stockpile of Tamiflu for use in a pandemic situation, with limited upfront investment and more adaptability to deal with unknown factors inherent in pandemic planning. 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528612null HTML http://biopharminternational.findpharma.com/biopharm/Boehringer-Ingelheim-to-Acquire-Actimis-Pharmaceut/ArticleStandard/Article/detail/528616?ref=25 Boehringer Ingelheim GmbH (Ingelheim, Germany) will acquire Actimis Pharmaceuticals, Inc. (San Diego, CA), through a structured buyout in which Boehringer Ingelheim will acquire shares of Actimis depending on the achievement of several successive milestones with Actimis’s leading asthma compound AP768. 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528616null HTML http://biopharminternational.findpharma.com/biopharm/David-Horowitz-Appointed-Assistant-Commissioner-fo/ArticleStandard/Article/detail/528621?ref=25 The FDA has appointed David Horowitz as the assistant commissioner for policy. 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528621null HTML http://biopharminternational.findpharma.com/biopharm/Eden-Biodesign-Expands-US-operations/ArticleStandard/Article/detail/528609?ref=25 Eden Biodesign, Ltd. (Liverpool, UK), has confirmed its expansion plans for Eden Biodesign, Inc., the Group’s US subsidiary, with the announcement of a facility in the highly coveted biotech hub, Research Triangle Park, NC. 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528609null HTML http://biopharminternational.findpharma.com/biopharm/News/US-and-Vietnam-Join-Hands-for-Drug-Safety/ArticleStandard/Article/detail/528607?ref=25 The United States and the Socialist Republic of Vietnam have signed a memorandum of understanding (MOU) to enhance the safety of food, feed, drugs, and medical devices traded between the two nations. 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528607null HTML http://biopharminternational.findpharma.com/biopharm/News/BN-ImmunoTherapeutics-Starts-Clinical-Trials-with-/ArticleStandard/Article/detail/528613?ref=25 BN ImmunoTherapeutics, Inc. (Mountain View, CA), has initiated Phase 1/2 clinical studies with its therapeutic vaccine candidate against prostate cancer. 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528613null HTML http://biopharminternational.findpharma.com/biopharm/News/Peregrine-Awarded-DTRA-Contract-to-Develop-Bavitux/ArticleStandard/Article/detail/528618?ref=25 Peregrine Pharmaceuticals, Inc. (Tustin, CA), has entered into a five-year contract worth up to $44.4 million to test and develop bavituximab and an equivalent fully human antibody as potential broad-spectrum treatments for viral hemorrhagic fever infections. 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528618null HTML http://biopharminternational.findpharma.com/biopharm/News/Sanofi-Pasteur-Inaugurates-High-Tech-Vaccine-Produ/ArticleStandard/Article/detail/528611?ref=25 Sanofi Pasteur (Lyon, France), the vaccines division of the Sanofi-Aventis Group, has announced the inauguration of a high-tech vaccine production facility in France to respond to soaring demand worldwide. 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528611null HTML http://biopharminternational.findpharma.com/biopharm/Intas-Biopharma-Acquires-Biologics-Process-Develop/ArticleStandard/Article/detail/528615?ref=25 Intas Biopharmaceuticals Limited (IBPL, Ahmedabad, India) has acquired the US-based biotechnology corporation, Biologics Process Development Incorporated (BPD Inc., Poway, CA). 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528615null HTML http://biopharminternational.findpharma.com/biopharm/News/BIO-and-Battelle-Release-State-By-State-Analysis-o/ArticleStandard/Article/detail/528606?ref=25 The nation's bioscience industry continues to grow as states and regions vie to attract high-wage jobs, according to a study released on June 18, 2008, by Battelle (Columbus, OH) and the Biotechnology Industry Organization (BIO, Washington, DC). 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528606null HTML http://biopharminternational.findpharma.com/biopharm/News/New-Report-Outlines-Progress-Made-on-Import-Safety/ArticleStandard/Article/detail/528608?ref=25 Significant improvement has been made since last year to enhance the safety of imported products, according to a new report released by the interagency working group on import safety. 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528608null HTML http://biopharminternational.findpharma.com/biopharm/News/PacificGMP-and-Pacific-Biopharma-Group-to-Create-c/ArticleStandard/Article/detail/528614?ref=25 PacificGMP (San Diego, CA) and Pacific Biopharma Group (San Diego, CA) have signed a merger agreement to develop a cGMP (current good manufacturing practices) biologics contract manufacturing organization (CMO) in Taizhou, China. 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528614null HTML http://biopharminternational.findpharma.com/biopharm/ThromboGenics-and-BioInvent-Announce-a-Strategic-A/ArticleStandard/Article/detail/528617?ref=25 ThromboGenics NV (Leuven, Belgium) and BioInvent International AB (Lund, Sweden) have entered into a license agreement with Roche (Basel, Switzerland) for their jointly developed anti-cancer agent TB-403. 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528617null HTML http://biopharminternational.findpharma.com/biopharm/David-Mott-Leaving-MedImmune/ArticleStandard/Article/detail/528620?ref=25 Dave Mott, president and chief executive officer (CEO) of AstraZeneca’s (London, UK) biologics business unit, MedImmune (Gaithersburg, MD), has decided to leave the company at the end of July. 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528620null HTML http://biopharminternational.findpharma.com/biopharm/Damian-Marron-Appointed-CEO-of-Trophos/ArticleStandard/Article/detail/528622?ref=25 French biopharmaceutical company Trophos SA (Marseille, France) has appointed Damian Marron as chief executive officer. 2008-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/528622null HTML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Improving-Tangential-Flow-Filtration-Yield/ArticleStandard/Article/detail/527448?ref=25 Best methods to maximize product yield and membrane lifetime to enhance a tangential flow filtration process. 2008-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272008/527448/TFF_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/A-Rational-Approach-for-Setting-and-Maintaining-Sp/ArticleStandard/Article/detail/527447?ref=25 Resolve confusion about measurements. 2008-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272008/527447/0708_microbiology_lab_Wyeth_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Compliance+Notes/Coming-to-a-Biotech-Near-You-Quality-by-Design-Par/ArticleStandard/Article/detail/527446?ref=25 Quality by Design and Design Space can be used by companies to enhance process understanding, improve scientific rigor, and enhanced qualitative and quantative performance, as well as cost savings. 2008-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272008/527446null XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/Biotech-Innovation-Boosts-Orphan-Drug-Development/ArticleStandard/Article/detail/527445?ref=25 The US Food and Drugs Administration is boosting its efforts for orphan drugs development. 2008-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272008/527445null XML http://biopharminternational.findpharma.com/biopharm/India+Today/Indias-Bioinformatics-Industry-An-Engine-for-Globa/ArticleStandard/Article/detail/527511?ref=25 The bioinformatics industry is currently one of the fastest growing fields in India's biotechnology sector. Indian IT companies have several advantages in the bioinformation field and can continue to grow their opportunities worldwide. 2008-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272008/527511null XML http://biopharminternational.findpharma.com/biopharm/Final+Word/10-Key-Ways-to-Align-Your-Strategy-with-Execution/ArticleStandard/Article/detail/527449?ref=25 Best practices a pharmaceutical company can follow to execute their strategy sucessfully. 2008-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272008/527449null XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/Biotechs-New-Frontiers/ArticleStandard/Article/detail/527509?ref=25 Pushing frontiers in a maturing biotechnology industry. 2008-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272008/527509null XML http://biopharminternational.findpharma.com/biopharm/BiotechnologyIreland-Video/ArticleStandard/Article/detail/525695?ref=25 2008-06-24T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/262008/525695null HTML http://biopharminternational.findpharma.com/biopharm/Upstream++Processing+Whitepapers/Global-Biochemical-Profiling-for-Bioprocessing-Opt/ArticleStandard/Article/detail/523788?ref=25 It is widely understood that the production phase of bioprocessing can have a significant impact on the overall profitability of the biopharmaceutical. Organizations must analyze everything from total protein production level to glycosylation patterns as well as overall quality and stability. Given the large numbers of variables involved?especially in the composition of media nutrients?it is has been difficult to achieve globally optimal conditions using traditional analysis methods. This paper provides an overview of the type of relevant information that global biochemical profiling (metabolomics) can provide. Through this global analysis, one can not only measure these changes but also put them into biological context and?most importantly?into application. 2008-06-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523788null REMOTE http://biopharminternational.findpharma.com/biopharm/3M-Collaborates-with-IDRI-on-Vaccine-Adjuvants/ArticleStandard/Article/detail/523092?ref=25 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 for humanitarian efforts in developing countries. 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523092null HTML http://biopharminternational.findpharma.com/biopharm/BioPodcast-vaccines/ArticleStandard/Article/detail/523235?ref=25 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523235null HTML http://biopharminternational.findpharma.com/biopharm/BioPodcasts2008/ArticleStandard/Article/detail/523075?ref=25 Bio 2008 International Convention features live podcasts 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523075null HTML http://biopharminternational.findpharma.com/biopharm/News/USP-Updates-Guideline-for-Pending-Monographs/ArticleStandard/Article/detail/523086?ref=25 The US Pharmacopeial (USP) Convention (Rockville, MD) has announced updates to the guideline for its pending monographs approach. 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523086null HTML http://biopharminternational.findpharma.com/biopharm/News/BSPA-Roundtable-Addresses-Disposal-of-Disposables/ArticleStandard/Article/detail/523080?ref=25 As the use of disposable bioprocessing equipment has increased, a new question is gaining prominence: What is the best way to dispose of the equipment after use? 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523080null HTML http://biopharminternational.findpharma.com/biopharm/Wyeth-Receives-Fast-Track-Designation-for-its-13-v/ArticleStandard/Article/detail/523088?ref=25 The US Food and Drug Administration (FDA) has granted Fast Track designation to Wyeth Pharmaceuticals’ (Collegeville, PA) investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers. 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523088null HTML http://biopharminternational.findpharma.com/biopharm/GE-Healthcare-Licenses-Single-Use-Purification-Pla/ArticleStandard/Article/detail/523133?ref=25 SciLog, Inc. (Middleton, WI), a privately held company that designs and manufactures computer-controlled bioprocessing equipment, has announced the signing of a patent licensing agreement with GE Healthcare (Somerset, NJ). 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523133null HTML http://biopharminternational.findpharma.com/biopharm/Bavarian-Nordic-Enters-Clinical-Trials-with-HIV-Mu/ArticleStandard/Article/detail/523090?ref=25 Bavarian Nordic, (Kvistgaard, Denmark), has initiated a Phase 1–2 clinical study with its HIV vaccine candidate, MVA-BN HIV multiantigen. 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523090null HTML http://biopharminternational.findpharma.com/biopharm/Curtis-Rosebraugh-Appointed-Director-of-the-FDArsq/ArticleStandard/Article/detail/523138?ref=25 Curtis (Curt) Rosebraugh, MD, has been appointed as the new director of the US Food and Drug Administration’s (FDA) Office of Drug Evaluation II. 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523138null HTML http://biopharminternational.findpharma.com/biopharm/News/SemBioSys-Demonstrates-Functionality-of-its-Safflo/ArticleStandard/Article/detail/523083?ref=25 SemBioSys Genetics, Inc. (Calgary, Canada) has demonstrated that its safflower-produced Apo AI(Milano) is functional in a widely accepted animal model. 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523083null HTML http://biopharminternational.findpharma.com/biopharm/Ronald-Snee-Elected-to-the-International-Academy-f/ArticleStandard/Article/detail/523139?ref=25 Ronald D. Snee, PhD, a principal with Tunnell Consulting (King of Prussia, PA), has been elected to the International Academy for Quality (IAQ). 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523139null HTML http://biopharminternational.findpharma.com/biopharm/Felix-Negron-to-Lead-Pallrsquos-Global-Life-Scienc/ArticleStandard/Article/detail/523137?ref=25 Felix M. Negron, senior vice president at Pall Corporation (East Hills, NY), has been appointed to lead global manufacturing and supply chain operations for the company’s life sciences business. 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523137null HTML http://biopharminternational.findpharma.com/biopharm/Manufacturing-Strategies/ArticleStandard/Article/detail/523202?ref=25 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523202null HTML http://biopharminternational.findpharma.com/biopharm/BioPodcast-Outsourcing/ArticleStandard/Article/detail/523204?ref=25 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523204null HTML http://biopharminternational.findpharma.com/biopharm/Novartis-Gains-Rights-to-Antibiotic-with-Acquisiti/ArticleStandard/Article/detail/523093?ref=25 Novartis (Basel, Switzerland) will acquire Protez Pharmaceuticals (Malvern, PA) for up to $400 million in cash. 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523093null HTML http://biopharminternational.findpharma.com/biopharm/Bio-Podcast/ArticleStandard/Article/detail/523243?ref=25 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523243null HTML http://biopharminternational.findpharma.com/biopharm/Peng-Wang-Appointed-WuXi-PharmaTech-VP-of-Discover/ArticleStandard/Article/detail/523136?ref=25 WuXi PharmaTech (Shanghai, China) has appointed Peng Wang, PhD as vice president of discovery biology. 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523136null HTML http://biopharminternational.findpharma.com/biopharm/Daiichi-Sankyo-Acquires-U3-Pharma/ArticleStandard/Article/detail/523134?ref=25 Daiichi Sankyo Co., Ltd. (Tokyo, Japan) will acquire U3 Pharma AG (Martinsried, Germany), a German biotechnology company focusing on research into antibodies for the treatment of cancer. 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523134null HTML http://biopharminternational.findpharma.com/biopharm/News/Sweeping-Changes-Ahead-for-Biotech-Says-Ernst-amp-/ArticleStandard/Article/detail/523078?ref=25 The global biotechnology industry achieved record levels in financing and deal making in 2007, as investors and strategic partners showed strong confidence in the sector amid tightening global financial conditions that will continue to test the industry in 2008. 2008-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523078null HTML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/Administration-Proposes-Additional-275-Million-Fun/ArticleStandard/Article/detail/522994?ref=25 Health and Human Services Secretary Mike Leavitt has announced that his agency is amending its budget request for FY 2009 to include an additional $275 million for the FDA. 2008-06-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/522994null HTML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Maximizing-Yields-of-Plasmid-DNA-Processes/ArticleStandard/Article/detail/522163?ref=25 Recombinant protein and plasmid DNA production using microbial expression systems is the cornerstone of many biologics manufacturing processes. HCD methods are commonly used for these processes because of the advantages they provide. 2008-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522163null XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/The-Role-of-Media-Development-in-Process-Optimizat/ArticleStandard/Article/detail/522165?ref=25 With a variety of recombinant, animal-free, defined protein supplements such as growth factors, transferrin, and albumin entering the market, the biopharmaceutical industry now has innovative and safer alternatives to serum and other animal-derived supplements. 2008-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522165null XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Fusion-Tags-for-Protein-Expression-and-Purificatio/ArticleStandard/Article/detail/522166?ref=25 Gene fusion tags can improve the yield and solubility of many recombinant proteins. This article discusses the most popular fusion tags and the proteases used to remove them, with special reference to recently introduced technologies. 2008-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522166null XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Improving-Protein-Production-in-CHO-Cells/ArticleStandard/Article/detail/522164?ref=25 Using chemically defined feeds with CHO cell lines not only eliminates the variability associated with using plant hydrolysates, but could also improve the productivity of biopharmaceutical protein manufacture and help move therapeutic proteins into clinical trials more rapidly. 2008-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522164null XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Recombinant-Protein-Production-Yields-from-Mammali/ArticleStandard/Article/detail/522161?ref=25 A discussion of past achievements and future expectations of recombinant protein production yields from mammalian cells. 2008-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522161null XML http://biopharminternational.findpharma.com/biopharm/Quality/Avoiding-the-Pain-of-Out-of-Specification-Results/ArticleStandard/Article/detail/522197?ref=25 Improving your quality operations by using sound statistical principles. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522197/OOS_results_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/How-to-Evaluate-the-Cost-Impact-of-Using-Disposabl/ArticleStandard/Article/detail/522179?ref=25 The current focus on cost-of-goods (COGS) models is underplaying the benefits of disposables technology in biopharmaceutical manufacturing. The best method for accounting for the benefits of reduced and delayed capital expenditures is through the use of NPV analysis. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522179null XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/A-Rational-Approach-for-Setting-and-Maintaining-Sp/ArticleStandard/Article/detail/522182?ref=25 A staged approach to limits should embrace future capabilities. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522182/0608_microbiology_lab_Wyeth_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Statistics+Essentials/The-Power-of-Hypothesis/ArticleStandard/Article/detail/522180?ref=25 How to use hypothesis correctly, and understanding the difference between one-sample, two-sample, and z-test. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522180null XML http://biopharminternational.findpharma.com/biopharm/Final+Word/Validation-Failure-is-Not-an-Option-Should-it-be/ArticleStandard/Article/detail/522204?ref=25 The industry needs to open up to validation failures. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522204null XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/Healthcare-Reform-Threatens-Biotech-Coverage-and-A/ArticleStandard/Article/detail/522176?ref=25 The comparative research approach may be preferable to price controls in the guise of government negotiations for the Medicare drug benefit, coverage denials, and limits on access to new technologies. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522176null XML http://biopharminternational.findpharma.com/biopharm/Perspectives+on+Outsourcing/Considerations-When-Outsourcing-the-Production-of-/ArticleStandard/Article/detail/522177?ref=25 It is important to understand critical aspects of the CMO's capabilities. Only by auditing certain key areas can the sponsor be assured of the quality of the materials produced. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522177null XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Modeling-of-Biopharmaceutical-ProcessesmdashPart-1/ArticleStandard/Article/detail/522184?ref=25 Process-modeling tools can ensure smooth tech transfer. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522184/Fermentation_cell_culture_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Burrill+on+Biotech/Biotech-Survives-Difficult-Opening-to-2008/ArticleStandard/Article/detail/522181?ref=25 Following the market crisis of the first quarter of 2008, biotech IPOs and financing are down, but partnering continues, and mergers and acquisitions (M&As) remain hot. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522181null XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/Funding-the-FDA-Finally/ArticleStandard/Article/detail/522174?ref=25 A stronger FDA will benefit both the industry and the public. And it now looks like we are starting down a path to build up that strength. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522174null XML http://biopharminternational.findpharma.com/biopharm/Upstream++Processing+Whitepapers/Fermentation-Process-Monitoring-II-Mammalian-Cell-/ArticleStandard/Article/detail/520175?ref=25 In-situ FTIR spectroscopy using a sterilizable sampling head is an ideal method for monitoring bioprocesses such as mammalian cell cultures, making it possible to track nutrients and waste products in real time. 2008-05-30T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/222008/520175null REMOTE http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-Expanded-Adjuvant-Indications-for-Her/ArticleStandard/Article/detail/518867?ref=25 US Food and Drug Administration's Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer. 2008-05-23T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/212008/518867null HTML http://biopharminternational.findpharma.com/biopharm/Revised-Prix-Galien-brocure/ArticleStandard/Article/detail/518368?ref=25 Revised Prix Galien brochure 2008-05-21T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/212008/518368null PDF http://biopharminternational.findpharma.com/biopharm/Prix-Galien-Sponsor-Booklet/ArticleStandard/Article/detail/517487?ref=25 Prix Galien Sponsor 2008-05-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202008/517487null PDF http://biopharminternational.findpharma.com/biopharm/About-Us/ArticleStandard/Article/detail/3297?ref=25 About BioPharm 2008-05-15T04:00:00Z HTML http://biopharminternational.findpharma.com/biopharm/Outsourcing/Characterization-of-anti-HCP-Antibodies-by-2D-HPLC/ArticleStandard/Article/detail/516721?ref=25 The characterization of complex polyclonal anti-HCP antibodies has traditionally been accomplished by 2 dimensional Western blot as correlated to a non-specific silver stain. We discuss the limitations of this method and suggest 2D HPLC fractionation of HCPs followed by ELISA detection as a much more sensitive, specific, and quantitative method to detect individual HCPs. This paper shows data comparing the 2 methods on both an upstream and final drug substance sample. 2008-05-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202008/516721null REMOTE http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Whitepapers/Asset-Management-for-Growing-Biotech-Companies/ArticleStandard/Article/detail/516024?ref=25 The biotechnology industry has mushroomed over the past decade, with revenues increasing from $8 billion in 1992 to $39 billion in 2003,1 and it shows no signs of slowing down. New therapeutics are entering and pressing through clinical trials. Treatments are emerging from clinical trials ready for marketing and scaling up for commercial production, leading to a growing need for new facilities. 2008-05-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/516024null REMOTE http://biopharminternational.findpharma.com/biopharm/News/DSM-Biologics-and-Upfront-to-Develop-a-Fully-Dispo/ArticleStandard/Article/detail/515562?ref=25 DSM Biologics (Heerlen, the Netherlands), and Upfront Chromatography A/S (Copenhagen, Denmark) have announced a collaboration to optimize Upfront’s new, fully disposable chromatography system for use with DSM's proprietary manufacturing technology. 2008-05-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/515562null HTML http://biopharminternational.findpharma.com/biopharm/News/Eli-Lilly-and-NIBRT-Enter-Research-Collaboration/ArticleStandard/Article/detail/515561?ref=25 The National Institute for Bioprocessing Research and Training (NIBRT, Dublin, Ireland) has entered into a new research collaboration with US pharmaceutical company Eli Lilly (Indianapolis, IN). 2008-05-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/515561null HTML