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Top Stories
The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.
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The European Medicines Agency has recommended Luxturna (voretigene neparvovec) as the first treatment option for hereditary retinal dystrophy with mutations of the RPE65 gene.
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Subscribers can enjoy each full issue of Pharm Tech in print, or via Pharm Tech apps.
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Industry News
Experts suggest health care providers and policymakers proceed with caution when exposing patients to the digital pill.
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Research by Thermo Fisher Scientific and LumaCyte suggests that LumaCyte's Radiance instrument offers the ability to rapidly analyze viral vaccines to speed development and production and ensure their effectiveness.
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Supplier News
Nanjing-based PharmaBlock Sciences acquired a GMP-compliant manufacturing facility in Shangyu, China from Porton Pharma Solutions.
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The contract development and manufacturing organization expanded its analytical chemistry suite and added a new office in Boston, MA.
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Bio/Pharma News
The agency will review Praluent (alirocumab) Injection, a PCSK9 inhibitor, as a possible treatment of cardiovascular events.
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The company announced it is creating a new Primary Care global business unit and a China & Emerging Markets unit.
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Regulatory News
The agreement now includes 15 European Union (EU) member states.
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FDA awarded nearly $3 million in grants for continuous manufacturing and other advanced manufacturing technologies as part of the agency’s efforts to ensure a robust and reliable supply of biological products.
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APPLICATION NOTE
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Knowledge of API solid state behavior is essential for drug product manufacturing, patent protection, and formulation viability. This paper discusses various aspects of solid state characterization which impacts product development.  / read more / |
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PEER-REVIEWED RESEARCH
This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
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EU REGULATORY WATCH
The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.
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PI18083 24th Annual Validation Week:
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry.  Learn More |
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CPhI Worldwide 2018 Exhibitor Guide
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Capsule Delivery Solutions, part of Lonza Pharma & Biotech, is the leader in capsule-based solutions and services, proudly offering Capsugel® products. / read more / |
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Vetter's service portfolio ranges from development support including clinical manufacturing to commercial supply and packaging solutions for prefilled syringes, vials, and cartridges. / read more / |
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New Products/Services
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Ross Bow Tie Dispersers, or High Viscosity Dispersers, are heavyduty mixers designed for heavy pastes and viscous liquids up to several hundred thousand centipoise, with stainless steel 304 wetted parts. / read more / |
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UPCOMING WEBCASTS
Sterility Testing: Best Practices and Use of Isolator Technology
Tuesday, October 23, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Successfully Navigating the Analytical Environment of Complex Generic APIs
Tuesday, October 16, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Implementing Transmission Raman for Fast Content Uniformity Testing – from Feasibility Evaluation to a Validated Release Method
Europe: Thursday, October 11, 2018 at 2pm BST/ 3pm CEST
North America: Thursday, October 11, 2018 at 11am EDT/ 8am PDT/ 10am CDT
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Facing Inactive Ingredient Database Challenges? Navigating the Complexity for Successful Regulatory Filings
Tuesday, October 2, 2018 at 11am EDT | 10am CDT | 4pm BST | 5pm CEST
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Events
October 9–11, 2018
October 9–11, 2018
October 14–17, 2018
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eBOOKS
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This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics. |
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