| July 2015, Volume 11 Issue 7
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Supply Chain Management
The agency takes action against websites that illegally sell unapproved medications.
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Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.
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The European Medicines Verification Organization has signed agreements with service providers to establish blueprint systems in compliance with the Falsified Medicines Directive.
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SOLID DOSAGE AND EXCIPIENTS EBOOK
Pharmaceutical Technology's 2015 Solid Dosage and Excipients eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms.
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In-depth analyses. Searchable online databases. Monthly and quarterly newsletters from Jim Miller and his expert staff. All focused on the bio/pharmaceutical outsourcing industry and emerging markets. We keep you informed about what is driving change and how it will impact your business.
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A 25,000-sq-ft cargo facility at Philadelphia International Airport offers different levels of temperature storage.
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Bylo has been selected to lead the GS1 Healthcare US Industry Initiative, focused on driving adoption and usage of GS1 Standards in healthcare.
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A recent Ernst & Young survey highlights the challenges facing Indian pharma.
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Solubility Enhancement
Solutions Using Predictive Analytics & Molecular Modeling
On Demand
Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.
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API Synthesis & Manufacturing
Cynthia A. Challener
Research to develop alternative approaches may enable hazardous transformations to be performed safely on a commercial scale.
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Outsourcing Update
Eric Langer
More biopharma companies choose outside service providers for assay testing.
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Stability Assessment for Shipment of API and Drug Products
On Demand
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.
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Regulation and Compliance
Jill Wechsler
Regulators and industry seek to streamline and harmonize oversight of manufacturing changes for firms that adopt modern production methods.
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The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.
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Practical Guidance for Successful Mammalian Cell Banking and Cell Line Characterization
On Demand
Join us for this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to
learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
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Contract Services Update
Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.
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The combined company has been created through the integration of Huntingdon Life Sciences and Harlan Laboratories announces a new company name.
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Reach Separations has announced plans to double its laboratory space at its Nottingham facility as a result of increased demand for its specialist purification services.
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apceth has completed a major GMP inspection for two medicinal products.
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Waiting for the content
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Lonza's planned facility will be used to develop and manufacture viral gene therapies and virally modified cell therapies.
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Vetter completes on-site expansion activities of visual inspection and in-process control at Chicago facility.
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Catalent's Singapore facility is awarded GMP certification.
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West Pharmaceutical began construction on its component manufacturing facility located in Waterford, Ireland.
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A new GMP facility in Massachusetts will produce enzymes and other reagents for in-vitro diagnostics.
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Lyophilization Services of New England announces inspection approvals that will allow its Bedford, NH facility to begin manufacturing commercial drugs for US distribution.
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Webcasts
Tuesday, July 7, 2015, 10 am EDT
In this live webinar, experts will showcase how to formulate a peroxide-sensitive drug using a binder that combines high binding strength with no peroxide formation at all.
Sponsored by: BASF
On Demand
As global requirements for pharma supply chain safety become more stringent, pharmaceutical manufacturers need to be more proactive in monitoring supply chain partners to ensure security and quality. In this program, an expert shares best practices that will prevent liability and noncompliance, improve quality and boost supply chain efficiency.
Sponsored by: Spectrum Chemical Mfg. Corp.
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