http://www.biopharminternational.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. 2013-06-19T13:23:44Z http://www.biopharminternational.com/biopharm/News/Cobra-Biologics-Announces-Development-Projects/ArticleStandard/Article/detail/815871?ref=25 Cobra Biologics announced several product development projects with Novolytics, Recopharma, and Vaccibody. 2013-06-14T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815871null HTML http://www.biopharminternational.com/biopharm/News/Supreme-Court-Human-Genes-Are-Not-Patentable/ArticleStandard/Article/detail/815850?ref=25 The US Supreme Court ruled that naturally occurring isolated biological material is not patentable, but a synthetic version of gene material may be patented. 2013-06-14T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815850null HTML http://www.biopharminternational.com/biopharm/News/ISPE-Study-Reports-on-Root-Causes-for-Drug-Shortag/ArticleStandard/Article/detail/815863?ref=25 ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages. 2013-06-12T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815863null HTML http://www.biopharminternational.com/biopharm/News/EMA-Revises-Biosimilars-Guideline/ArticleStandard/Article/detail/815479?ref=25 EMA?s revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation. 2013-06-11T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815479null HTML http://www.biopharminternational.com/biopharm/News/FDA-Issues-Warning-Letter-to-Baxter-Healthcare/ArticleStandard/Article/detail/815505?ref=25 FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico. 2013-06-11T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815505null HTML http://www.biopharminternational.com/biopharm/Online+Only/Elan-Board-Rejects-Multibillion-Takeover-Bid-from-/ArticleStandard/Article/detail/815471?ref=25 Elan urges its shareholders to reject bid in an upcoming meeting on June 17. 2013-06-11T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815471null HTML http://www.biopharminternational.com/biopharm/News/USP-Forms-Elemental-Impurities-Advisory-Group/ArticleStandard/Article/detail/815480?ref=25 USP appoints regulatory experts to elemental impurities implementation advisory group. 2013-06-11T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815480null HTML http://www.biopharminternational.com/biopharm/News/GlaxoSmithKline-Acknowledges-Misrepresentation-in-/ArticleStandard/Article/detail/815508?ref=25 One employee is dismissed, another has resigned, and three others are put on administrative leave. 2013-06-11T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815508null HTML http://www.biopharminternational.com/biopharm/News/Pfizer-Partners-with-CytomX-for-Antibody-Drug-Conj/ArticleStandard/Article/detail/815490?ref=25 The multimillion deal focuses on oncology. 2013-06-11T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815490null HTML http://www.biopharminternational.com/biopharm/Online+Only/Boehringer-Ingelheim-Plans-Biopharmaceuticals-Faci/ArticleStandard/Article/detail/815238?ref=25 Facility will use mammalian cell-culture technology and be ready for operations by 2016. 2013-06-10T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815238null HTML http://www.biopharminternational.com/biopharm/News/AstraZeneca-to-Acquire-Pearl-Therapeutics/ArticleStandard/Article/detail/815237?ref=25 Acquisition will strengthen AstraZeneca?s respiratory portfolio with a potential new treatment for chronic obstructive pulmonary disease. 2013-06-10T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815237null HTML http://www.biopharminternational.com/biopharm/Online+Only/Janssen-and-Second-Genome-Partner-on-Microbiome-Dr/ArticleStandard/Article/detail/815239?ref=25 Agreement seeks to advance novel drug targets and focus on therapies for ulcerative colitis. 2013-06-10T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815239null HTML http://www.biopharminternational.com/biopharm/News/FDA-Discovers-Microbial-Contamination-in-Compound-/ArticleStandard/Article/detail/815072?ref=25 FDA Discovers Microbial Contamination in Compound Pharmacy Products 2013-06-06T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/815072null HTML http://www.biopharminternational.com/biopharm/News/Celerion-Adds-Containment-Room/ArticleStandard/Article/detail/814982?ref=25 Modular containment room at Belfast facility allows studies of biologics and vaccines. 2013-06-05T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814982null HTML http://www.biopharminternational.com/biopharm/News/Novartis-Receives-FDA-Warning-Letter-for-cGMP-Viol/ArticleStandard/Article/detail/814944?ref=25 The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections. 2013-06-05T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814944null HTML http://www.biopharminternational.com/biopharm/News/Sanofi-Ends-Development-of-Two-Phase-III-Drugs/ArticleStandard/Article/detail/815218?ref=25 - 2013-06-04T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815218null HTML http://www.biopharminternational.com/biopharm/Company+and+People+Notes/MorphoSys-and-GlaxoSmithKline-Partner-in-Antibody-/ArticleStandard/Article/detail/814805?ref=25 - 2013-06-04T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814805null HTML http://www.biopharminternational.com/biopharm/News/MorphoSys-and-GSK-Partner-in-Antibody-Pact/ArticleStandard/Article/detail/815217?ref=25 The agreement is worth up to $552 million, depending on meeting set milestones. 2013-06-04T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815217null HTML http://www.biopharminternational.com/biopharm/Manufacturing+Best+Practices/Flexibility-in-Biopharmaceutical-Manufacturing/ArticleStandard/Article/detail/814880?ref=25 Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results. 2013-06-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814880null XML http://www.biopharminternational.com/biopharm/Quality/The-Meaning-of-Metrics/ArticleStandard/Article/detail/814881?ref=25 Companies can use metrics as a tool to help drive positive change and quality process improvements. 2013-06-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814881null XML http://www.biopharminternational.com/biopharm/Feature+Rotating+Article/An-Integrated-Prefilled-Syringe-Platform-Approach-/ArticleStandard/Article/detail/814884?ref=25 An integrated focus on product design, development, operation, and control. 2013-06-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814884/bp06_prefilled_t_flash.jpg XML http://www.biopharminternational.com/biopharm/Standards+%26+Regulation/Navigating-Emerging-Markets-Southeast-Asia/ArticleStandard/Article/detail/814888?ref=25 A unique demographic and payer mix make ASEAN an increasingly attractive region. 2013-06-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814888null XML http://www.biopharminternational.com/biopharm/Feature+Rotating+Article/A-Generic-Growth-Test-Method-for-Improving-Quality/ArticleStandard/Article/detail/814887?ref=25 Quality control for disposable-bags 2013-06-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814887/bp06_peer_t_flash.jpg XML http://www.biopharminternational.com/biopharm/Basic+Training/Misconceptions-of-Maintenance-and-Reliability-A-Bi/ArticleStandard/Article/detail/814883?ref=25 The authors provide common misconceptions and key concepts behind reliability engineering. 2013-06-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814883null XML http://www.biopharminternational.com/biopharm/Report-from-Taiwan/ArticleStandard/Article/detail/814886?ref=25 The Taiwanese government engages in regulatory science in a move to boost its pharmaceutical sector. 2013-06-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814886/bp06_global_t_flash.jpg XML http://www.biopharminternational.com/biopharm/Feature+Rotating+Article/Using-Plastic-for-Parenteral-Containers/ArticleStandard/Article/detail/814882?ref=25 A Q&A with SCHOTT Pharmaceutical Systems and West Pharmaceutical Services 2013-06-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814882/bp06_plastic_t_flash.jpg XML http://www.biopharminternational.com/biopharm/From+the+Editor/Trust-in-the-Pill-Bottle/ArticleStandard/Article/detail/814885?ref=25 Ranbaxy's $500 million settlement for producing adulterated drugs and fradulent data provides a cautionary tale for patients, FDA, and drug manufacturers. 2013-06-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814885null XML http://www.biopharminternational.com/biopharm/Outsourcing/Drug-Approval-Trends-Dont-Extend-to-CMOs/ArticleStandard/Article/detail/815156?ref=25 Approvals of new drugs are on an upward swing, but only a few CMOs are benefiting. 2013-06-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/242013/815156null XML http://www.biopharminternational.com/biopharm/Standards+%26+Regulation/A-Lifecycle-Approach-to-Process-Validation/ArticleStandard/Article/detail/814889?ref=25 A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes. 2013-06-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814889null XML http://www.biopharminternational.com/biopharm/Standards+%26+Regulation/Congress-Considers-Legislation-to-Secure-Drug-Supp/ArticleStandard/Article/detail/814879?ref=25 Bills to regulate drug compounding and establish a national track and trace system face political and policy differences. 2013-06-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814879null XML http://www.biopharminternational.com/biopharm/Analytical+Methods+Articles/New-Analytical-Testing-Procedures-and-Instruments-/ArticleStandard/Article/detail/814675?ref=25 Rita Peters, Editorial Director for Pharmaceutical Technology and BioPharm Inernational talks with Ferdinand Dabu, director of marketing at SGS live at Interphex 2013 about extractables and leachables. In this interview they discuss new analytical testing procedures and instruments that are facilitating the testing processes or improving results. 2013-05-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814675null HTML http://www.biopharminternational.com/biopharm/News/GSK-Acquires-Vaccine-Platform-Tech-Company-Okairos/ArticleStandard/Article/detail/814440?ref=25 GSK expands its vaccines platform technology expertise by acquiring Okairos, a Swiss-based company. 2013-05-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814440null HTML http://www.biopharminternational.com/biopharm/News/Institution-of-Chemical-Engineers-Discusses-Proces/ArticleStandard/Article/detail/814489?ref=25 Competence in process safety is important for preventing accidents. 2013-05-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814489null HTML http://www.biopharminternational.com/biopharm/News/BT-and-Accelrys-Unlock-Value-in-Big-Data/ArticleStandard/Article/detail/814488?ref=25 Cloud-computing solutions and software enable researchers to garner insight from large, public-health datasets. 2013-05-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814488null HTML http://www.biopharminternational.com/biopharm/Analytical+Methods+Articles/Special-Considerations-for-Testing-for-Extractable/ArticleStandard/Article/detail/814674?ref=25 Rita Peters, Editorial Director for Pharmaceutical Technology and BioPharm Inernational talks with Ferdinand Dabu, director of marketing at SGS live at Interphex 2013 about extractables and leachables. In this interview they discuss special considerations for testing for extractables and leachables for both small molecule and biological drug development. 2013-05-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814674null HTML http://www.biopharminternational.com/biopharm/News/FDA-Fights-Drug-Shortage-with-Import-of-Injectable/ArticleStandard/Article/detail/814453?ref=25 FDA addresses shortages of drugs needed to treat premature infants and patients unable to eat or drink by mouth. 2013-05-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814453null HTML http://www.biopharminternational.com/biopharm/News/ISTA-Pharmaceuticals-Inc-Pleads-Guilty-to-Federal-/ArticleStandard/Article/detail/814452?ref=25 ISTA will pay $33.5 million to resolve criminal liability and false claims allegations. 2013-05-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814452null HTML http://www.biopharminternational.com/biopharm/Analytical+Methods+Articles/Key-Elements-of-an-Effective-Testing-Program-to-Id/ArticleStandard/Article/detail/814673?ref=25 Rita Peters, Editorial Director for Pharmaceutical Technology and BioPharm Inernational talks with Ferdinand Dabu, director of marketing at SGS live at Interphex 2013 about extractables and leachables. In this interview they discuss the key elements of an effective testing program to identify extractables from materials and leachables in drug products. 2013-05-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/232013/814673null HTML http://www.biopharminternational.com/biopharm/Disposables/Growth-in-Single-Use-Technology-Video/ArticleStandard/Article/detail/814553?ref=25 Rita Peters, Editorial Director for Pharmaceutical Technology and BioPharm Inernational talks with Mani Krishnan, director of systems at EMD Millipore live at Interphex 2013 about single-use technology. In this interview they discuss areas of growth in single-use technology as well as reservations that some companies have to switching to single-use systems Krishnan identifies a few technology advances that are overcoming these objections as well as decision-making strategies for facilities considering a switch to a single-use system. 2013-05-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814553null HTML http://www.biopharminternational.com/biopharm/Johnson-amp-Johnsons-Pharma-Sector-Poised-for-Grow/ArticleStandard/Article/detail/814483?ref=25 Johnson & Johnson anticipates submitting more than 10 new product filings and more than 25 significant brand line extensions by 2017; the announcement was made at a recent meeting with industry analysts. Upcoming new products include simeprevir for hepatitis C (already filed in Japan, Europe and the US); ibrutinib and daratumumab for haematologic malignancies; sirukumab and guselkumab for diseases of the immune system such as rheumatoid arthritis and psoriasis; and vaccines for influenza, rabies and polio. 2013-05-28T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814483null HTML http://www.biopharminternational.com/biopharm/Whitepapers/Analysis-of-Polyethylene-Glycol-PEG-and-a-Mono-and/ArticleStandard/Article/detail/814255?ref=25 A method using LC/MS is described for improving the analysis PEGylated peptides and proteins using the post-column addition of a charge stripping agent to obtain simpler mass spectra for detailed structural characterization. 2013-05-28T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814255null REMOTE http://www.biopharminternational.com/biopharm/Upstream++Processing+Whitepapers/Automated-Dynamic-Light-Scattering-for-Aggregation/ArticleStandard/Article/detail/814256?ref=25 Promiscuous non-stoichiometric inhibition can be a serious problem when screening libraries of compounds in a high-throughput format. A rapid method of detecting such compound behavior can be achieved using a DynaPro Plate Reader to examine the light scattering properties of a dilution series of known aggregating inhibitors. 2013-05-28T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814256null REMOTE http://www.biopharminternational.com/biopharm/Whitepapers/Characterization-of-Glycosylation-in-the-Fc-Region/ArticleStandard/Article/detail/814254?ref=25 In this note, we describe a fast and efficient liquid chromatography-TOF mass spectrometry approach to characterize an IgG derived from CHO cells. An Agilent Poroshell 300SB-C3, 5 um superficially porous IgG1 column was used to obtain accurate glycoform masses of an intact IgG1, with a subsequent analysis of papain-digeste3d IgG1 to obtain site-specific glycosylation profile information of the Fc region for further characterization of IgG1 heterogeneity. Additionally, a subsequent mAb-glyco chip LC/MS analysis was used to build a glycan accurate mass database for additional validation of the glycans identified in the TOF mass analysis. 2013-05-28T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814254null REMOTE http://www.biopharminternational.com/biopharm/Upstream++Processing+Whitepapers/Reconstitution-of-a-High-Concentration-Protein-Dru/ArticleStandard/Article/detail/814253?ref=25 A case study reviews the challenges in reducing reconstitution time of a recombinant protein. The example may provide useful information and practical guidelines for the development of other high-concentration protein drug products. 2013-05-28T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814253null REMOTE http://www.biopharminternational.com/biopharm/Whitepapers/Analysis-of-Erythropoietin-Glycopeptides-and-Glyco/ArticleStandard/Article/detail/814250?ref=25 Reversed-phase UHPLC/HPLC is routinely used for peptide mapping, but if the digest contains hydrophilic peptides, such as glycopeptides, valuable information can be missed. This note demonstrates peptide mapping of digested glycoprotein erythropoietin (EPO) protein using an Agilent ZORBAX Rapid Resolution High Definition 300-HILIC 1.8 ?m LC column and a TOF MS. Taking advantage of the high organic solvent system of the mobile phase for HILIC (hydrophilic interaction chromatography), the glycopeptides are effectively dissolved, retained and separated by the HILIC column. This app note includes the separation, sequence coverage and comparison of reversed-phase and HILIC data to demonstrate the utility of HILIC as an orthogonal and complementary approach to RPLC/MS for peptide analysis. 2013-05-28T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814250null REMOTE http://www.biopharminternational.com/biopharm/Downstream+Processing+Whitepapers/Purification-of-Oligonucleotides-on-TOYOPEARL-Giga/ArticleStandard/Article/detail/814251?ref=25 TOYOPEARL GigaCap Q-650S is capable of delivering oligonucleotides of comparable purity to that seen with the TSKgel® SuperQ-5PW (20) resin and at slightly higher process yields under the same loading conditions but at lower pressures. 2013-05-28T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814251null REMOTE http://www.biopharminternational.com/biopharm/Quality/Automated-Fiber-Particle-Imaging-and-Characterizat/ArticleStandard/Article/detail/814252?ref=25 This application note details how imaging particle analysis automatically characterizes fibrous particles using the actual image and shape in addition to ESD. This allows each, individual fiber to be accurately measured for the degree of curl, straightness, length, width and other parameters, and to be automatically differentiated from each other. 2013-05-28T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814252null REMOTE http://www.biopharminternational.com/biopharm/News/USP-Defers-Implementation-of-Elemental-Impurities-/ArticleStandard/Article/detail/814249?ref=25 USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities. 2013-05-28T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814249null HTML http://www.biopharminternational.com/biopharm/News/FDA-Issues-Draft-Guidance-on-Contract-Manufacturin/ArticleStandard/Article/detail/814273?ref=25 The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products. 2013-05-28T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814273null HTML http://www.biopharminternational.com/biopharm/Whitepapers/Driving-Innovation-in-BioPharma-with-Product-Lifec/ArticleStandard/Article/detail/814258?ref=25 This white paper explores how product lifecycle management (PLM) can enable biopharma companies to develop innovative products that generate real economic benefits for their organizations and health benefits for patients. 2013-05-28T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814258null REMOTE http://www.biopharminternational.com/biopharm/News/FDA-Issues-Warning-Letter-to-Boehringer-Ingelheim-/ArticleStandard/Article/detail/814243?ref=25 Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products from its facility in Ingelheim am Rhein, Germany. 2013-05-28T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814243null HTML http://www.biopharminternational.com/biopharm/News/SCHOTT-Introduces-Cartridge-Design-for-High-Speed-/ArticleStandard/Article/detail/814058?ref=25 New design meets new process requirements. 2013-05-23T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/212013/814058null HTML http://www.biopharminternational.com/biopharm/Analytical+Methods+Articles/Extractables-and-Leachables-Video/ArticleStandard/Article/detail/814554?ref=25 Editorial Director Rita Peters talks to with Ferdinand Dabu Director of Marketing at SGS live at Interphex 2013-05-23T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/222013/814554null HTML http://www.biopharminternational.com/biopharm/US-Government-Signs-Deal-with-GSK-to-Develop-Antib/ArticleStandard/Article/detail/814062?ref=25 Partnership will support development of drugs to fight antibiotic resistance and bioterrorism. 2013-05-23T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/212013/814062null HTML http://www.biopharminternational.com/biopharm/News/EMD-Millipore-Collaborates-with-PharmaCell-on-Larg/ArticleStandard/Article/detail/814059?ref=25 Project will optimize expansion and harvest of human cells in bioreactors. 2013-05-23T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/212013/814059null HTML http://www.biopharminternational.com/biopharm/SGS---Reconstitution-of-a-High-Concentration-Prote/ArticleStandard/Article/detail/813819?ref=25 SGS - Reconstitution of a High-Concentration Protein Drug Product 2013-05-21T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/212013/813819null HTML http://www.biopharminternational.com/biopharm/USP-Offers-Herbal-Medicines-Compendium/ArticleStandard/Article/detail/813824?ref=25 The U.S. Pharmacopeial Convention is offering free online access to public standards to help ensure the quality of the herbal ingredients used in medicinal products. 2013-05-20T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/212013/813824null HTML http://www.biopharminternational.com/biopharm/Actavis-to-Acquire-Warner-Chilcott/ArticleStandard/Article/detail/813825?ref=25 Actavis Inc. and Warner Chilcott plc have entered into a definitive agreement under which Actavis will acquire Warner Chilcott plc in a stock-for-stock transaction valued at approximately $8.5 billion. 2013-05-20T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/212013/813825null HTML http://www.biopharminternational.com/biopharm/News/Moscow-Hosts-IFPMA-Biosimilars-Conference/ArticleStandard/Article/detail/813568?ref=25 Representatives of national health regulatory authorities from around the world convened in Moscow to discuss ways to harmonize regulatory standards for biotherapeutic medicines. 2013-05-17T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813568null HTML http://www.biopharminternational.com/biopharm/Agilent---Analysis-of-Polyethylene-Glycol-PEG-and-/ArticleStandard/Article/detail/813595?ref=25 Agilent - Analysis of Polyethylene Glycol (PEG) and a Mono and Di-PEGylated Therapeutic Protein Using HPLC and Q-TOF Mass Spectrometry 2013-05-17T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813595null HTML http://www.biopharminternational.com/biopharm/Tosoh---Purification-of-Oligonucleotides-on-TOYOPE/ArticleStandard/Article/detail/813596?ref=25 Tosoh - Purification of Oligonucleotides on TOYOPEARL GigaCap® Q-650S 2013-05-17T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813596null HTML http://www.biopharminternational.com/biopharm/Legislation-to-Protect-Subjects-in-Clinical-Trials/ArticleStandard/Article/detail/813823?ref=25 Legislation designed to protect clinical trial study participants, close loopholes, and bring certainty and public transparency to research studies, has been introduced. 2013-05-16T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/212013/813823null HTML http://www.biopharminternational.com/biopharm/Fluid-Imaging-Technologies---Automated-Fiber-Parti/ArticleStandard/Article/detail/813467?ref=25 Fluid Imaging Technologies - Automated Fiber Particle Imaging and Characterization Including Differentiating Fiber Curl from Straightness 2013-05-16T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813467null HTML http://www.biopharminternational.com/biopharm/Agilent---Characterization-of-Glycosylation-in-the/ArticleStandard/Article/detail/813478?ref=25 Agilent - Characterization of Glycosylation in the Fc Region of Therapeutic Recombinant Monoclonal Antibody 2013-05-16T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813478null HTML http://www.biopharminternational.com/biopharm/Kalypso---Driving-Innovation-in-BioPharma-with-Pro/ArticleStandard/Article/detail/813493?ref=25 Kalypso - Driving Innovation in BioPharma with Product Lifecycle Management 2013-05-16T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813493null HTML http://www.biopharminternational.com/biopharm/Wyatt---Automated-Dynamic-Light-Scattering-for-Agg/ArticleStandard/Article/detail/813280?ref=25 Wyatt - Automated Dynamic Light Scattering for Aggregation Detection 2013-05-15T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813280null HTML http://www.biopharminternational.com/biopharm/Report-Previews-Future-of-US-Biosimilar-Market/ArticleStandard/Article/detail/813822?ref=25 Thomson Reuters released a report that provides a view of the challenges facing companies entering the United States biosimilar drug market. 2013-05-15T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/212013/813822null HTML http://www.biopharminternational.com/biopharm/Online+Only/AbbVie-and-Alvine-Will-Collaborate-on-Celiac-Disea/ArticleStandard/Article/detail/813312?ref=25 Program aims to develop a novel oral treatment. 2013-05-15T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813312null HTML http://www.biopharminternational.com/biopharm/News/FDA-Issues-Pharmacoepidemiologic-Safety-Study-Guid/ArticleStandard/Article/detail/813185?ref=25 FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies. 2013-05-14T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813185null HTML http://www.biopharminternational.com/biopharm/Online+Only/Amgen-Forms-New-Joint-Venture-to-Commercialize-Vec/ArticleStandard/Article/detail/813590?ref=25 Amgen and Zhejiang Beta Pharma have signed an agreement to form a joint venture to commercialize Amgen's Vectibix (panitumumab) in the Chinese market. The aim is to quickly and efficiently deliver Vectibix to patients in China. Vectibix is a fully human anti-epidermal growth factor receptor (EGFR) antibody approved by FDA for the treatment of metastatic colorectal cancer. 2013-05-13T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813590null HTML http://www.biopharminternational.com/biopharm/News/USP-Launches-Initiative-to-Fight-Counterfeit-Drugs/ArticleStandard/Article/detail/813067?ref=25 New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries. 2013-05-13T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813067null HTML http://www.biopharminternational.com/biopharm/Amgen-Forms-New-Joint-Venture-to-Commercialize-Vec/ArticleStandard/Article/detail/813556?ref=25 Amgen and Zhejiang Beta Pharma have signed an agreement to form a joint venture to commercialize Amgen's Vectibix (panitumumab) in the Chinese market. The aim is to quickly and efficiently deliver Vectibix to patients in China. Vectibix is a fully human anti-epidermal growth factor receptor (EGFR) antibody approved by FDA for the treatment of metastatic colorectal cancer. 2013-05-13T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813556null HTML http://www.biopharminternational.com/biopharm/News/ATMI-Offers-Helium-Integrity-Testing-System/ArticleStandard/Article/detail/812850?ref=25 Evaluation system for single-use bags and assemblies is now available for onsite testing. 2013-05-10T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/192013/812850null HTML http://www.biopharminternational.com/biopharm/Online+Only/Schott-Doubles-Production-Capacity-for-Polymer-Syr/ArticleStandard/Article/detail/812720?ref=25 New line in Swiss facility produces ready-to-fill syringes. 2013-05-08T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/192013/812720null HTML http://www.biopharminternational.com/biopharm/News/EMA-Revises-Draft-Guideline-on-Biosimilars/ArticleStandard/Article/detail/812700?ref=25 EMA clarifies biosimilars guidelines. 2013-05-08T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/192013/812700null HTML http://www.biopharminternational.com/biopharm/News/FDA-Accepts-BLA-for-Mercks-Allergy-Immunotherapy-T/ArticleStandard/Article/detail/812908?ref=25 The FDA has accepted for review Merck's Biologics License Application for its investigational ragweed pollen sublingual allergy immunotherapy tablet. 2013-05-08T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/192013/812908null HTML http://www.biopharminternational.com/biopharm/Tamiflu-Leads-Q1-Drug-Sales-Growth/ArticleStandard/Article/detail/812901?ref=25 In the first quarter of 2013, the rankings for the top five drugs by sales shifted a bit, but exhibited positive growth for the quarter. 2013-05-07T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/192013/812901null HTML http://www.biopharminternational.com/biopharm/Manufacturing/The-Future-of-Valves-and-Diaphragms-Supply/ArticleStandard/Article/detail/813387?ref=25 The author discusses issues related to the supply of soft parts in the biopharma industry. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813387null XML http://www.biopharminternational.com/biopharm/Upstream++Processing+Whitepapers/HarvestClearsupTMsup-Filtration-System-for-harvest/ArticleStandard/Article/detail/812059?ref=25 The clarification of batch and fed-batch bioreactor systems can pose a practical challenge to biopharmaceutical manufacturers due to high cell densities. The HarvestClearTM Filtration System is an automated single-use system designed to optimize clarification of 1L to 20L high density bioreactor outputs, while reducing hands-on time and increasing operator safety. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/812059null REMOTE http://www.biopharminternational.com/biopharm/Regulation+and+Compliance/Should-Regulation-of-Combination-Products-Become-M/ArticleStandard/Article/detail/813390?ref=25 While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813390null XML http://www.biopharminternational.com/biopharm/News/Actemra-Receives-FDA-Approval-for-Polyarticular-Ju/ArticleStandard/Article/detail/812034?ref=25 Genentech announced that FDA has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in children aged two years and older. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/812034null HTML http://www.biopharminternational.com/biopharm/Quality/Data-and-Systems-Management/ArticleStandard/Article/detail/813386?ref=25 KR Karu from Sparta Systems spoke with BioPharm International about the importance of having an enterprise quality management system. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813386null XML http://www.biopharminternational.com/biopharm/Outsourcing/Outsourcings-Modest-Role-as-a-Cost-Containment-Str/ArticleStandard/Article/detail/813384?ref=25 Outsourcing is weighing in more as a tactic for cost-cutting, but it is still not the primary weapon. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813384null XML http://www.biopharminternational.com/biopharm/Feature+Rotating+Article/Facility-Trends-Modularization-and-Single-Use/ArticleStandard/Article/detail/813381?ref=25 BioPharm International spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813381null XML http://www.biopharminternational.com/biopharm/News/Pharmaco-Kinesis-Corporation-Develops-First-Nanodr/ArticleStandard/Article/detail/812035?ref=25 Pharmaco-Kinesis Corporation (PKC) announced that it is developing the first nanodrug combination of Merck's temozolomide and Celgene's thalidomide (in a 50:50 ratio) for the treatment of gliomas and other cancers. PKC will collaborate with the University of California, San Diego's department of nano-engineering at the Moores cancer centre to develop the nanodroplet formulation. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/812035null HTML http://www.biopharminternational.com/biopharm/Feature+Rotating+Article/New-Challenges-to-the-Cleanroom-Paradigm-for-Multi/ArticleStandard/Article/detail/813380?ref=25 Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813380/155280783_web_flash.jpg XML http://www.biopharminternational.com/biopharm/Feature+Rotating+Article/Process-Development-and-Spiking-Studies-for-Virus-/ArticleStandard/Article/detail/813389?ref=25 This study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of contamination. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813389/PeerRevButton_main.jpg http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813389/Peer-Review-Figure-2_web_flash.jpg XML http://www.biopharminternational.com/biopharm/Regulation+and+Compliance/Extractables-and-Leachables-Best-Practices-to-Ensu/ArticleStandard/Article/detail/813385?ref=25 The author presents best practices for extractables and leachables. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813385null XML http://www.biopharminternational.com/biopharm/Feature+Rotating+Article/Measuring-Protein-Mobility-with-Electrophoretic-Li/ArticleStandard/Article/detail/813378?ref=25 The author describes a method to avoid protein aggregation when using light scattering systems. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813378/BP0513_001_Without-Coverr1_web_flash.jpg XML http://www.biopharminternational.com/biopharm/From+the+Editor/The-Pathway-to-Publication/ArticleStandard/Article/detail/813379?ref=25 Wanted: Aspiring authors to share technical and scientific solutions for biopharmaceutical processing. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813379null XML http://www.biopharminternational.com/biopharm/Global+Reports/Report-from-Brazil/ArticleStandard/Article/detail/813383?ref=25 Prior to price escalation of pharmaceutical products in Brazil, the country's regulatory authority released a study on price-cap control and its benefits in the past years. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813383/162477774_web_flash.jpg XML http://www.biopharminternational.com/biopharm/Quality/Essentials-in-Quality-Risk-Management/ArticleStandard/Article/detail/813382?ref=25 Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813382/Analytical-BP_Figure-3r1_web_flash.jpg XML http://www.biopharminternational.com/biopharm/Regulation+and+Compliance/Regulatory-Convergence-Sought-for-Global-Pharma-Ma/ArticleStandard/Article/detail/813388?ref=25 Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813388null XML http://www.biopharminternational.com/biopharm/News/Bayer-to-Acquire-Conceptus-for-US11-Billion/ArticleStandard/Article/detail/812033?ref=25 Bayer announced that it has signed a merger agreement with US-based birth-control specialist Conceptus. 2013-04-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/812033null HTML http://www.biopharminternational.com/biopharm/Online+Only/PerkinElmer-Announces-Collaboration-with-Chinas-Na/ArticleStandard/Article/detail/811917?ref=25 A personalized drug research and development platform will validate biomarkers for individualized disease treatment for Chinese patients. 2013-04-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/811917null HTML http://www.biopharminternational.com/biopharm/Whitepapers/TOYOPEARL-GigaCapsupregsup-DEAE-650M-Preserving-Re/ArticleStandard/Article/detail/811990?ref=25 TOYOPEARL GigaCap DEAE-650M, a very high capacity anion exchange resin for process scale chromatography, offers chromatographers a combination of binding capacities greater than 150 g/L while maintaining peak resolution. 2013-04-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/811990null REMOTE http://www.biopharminternational.com/biopharm/Whitepapers/Protein-Separation-with-pH-Gradients-Using-Composi/ArticleStandard/Article/detail/811991?ref=25 Tips and tricks on how to correctly apply the Agilent Buffer Advisor Software for the generation of pH gradients over a wide range using composite buffer systems. 2013-04-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/811991null REMOTE http://www.biopharminternational.com/biopharm/News/Uhlmann-Group-Spins-Off-visiotec-GmbH/ArticleStandard/Article/detail/811916?ref=25 New company will focus on inspection, monitoring, and control systems for automated pharmaceutical manufacturing processes. 2013-04-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/811916null HTML http://www.biopharminternational.com/biopharm/Downstream+Processing+Whitepapers/Liposome-Characterization-by-FFF-MALS-QELS/ArticleStandard/Article/detail/811993?ref=25 Liposomes are made of lipid bilayers and are often used in drug delivery by encapsulating the core with therapeutic drugs. During liposome research, formulation, manufacturing and quality control, it is of great importance to monitor liposome size and encapsulation. Field flow fractionation (FFF) with the concomitant use of Multi-Angle Light Scattering (MALS) and Quasi-Elastic Light Scattering (QELS, aka dynamic light scattering) is an ideal tool for such characterization. 2013-04-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/811993null REMOTE http://www.biopharminternational.com/biopharm/Whitepapers/Thresholding-for-Accurate-Detection-and-Measuremen/ArticleStandard/Article/detail/811992?ref=25 This paper explains how adjusting the gray-scale threshold value using both darker and lighter pixels reveals transparent particles that would otherwise escape detection to ensure accurate count and concentration calculations. Protein agglomerate images demonstrate how properly varying threshold documents presence of one, large particle instead of several small particles. 2013-04-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/811992null REMOTE