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Top Stories
FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.
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The $425-million acquisition adds formulation development and finished dosage manufacturing capabilities to Cambrex's existing global API manufacturing network.
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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
Researchers at Vanderbilt University Medical Center have isolated the first human monoclonal antibodies (mAbs) that can neutralize norovirus, a virus that causes acute gastrointestinal (GI) illness.
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In the second half of CPhI's annual report, experts review industry trends and warn that trade and patent changes could increase healthcare cost by $100 billion over the next five years.
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Supplier News
The drug particle engineering and nanotechnology company offers a nanotechnology platform that can revive failed drugs in the pharma pipeline.
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The collaboration will focus on developing manufacturing solutions for biosimilars.
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Bio/Pharma News
The companies will develop therapies targeting the in-vivo elimination of hepatitis B virus (HBV) with Precision's proprietary genome editing platform.
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Avara Pharmaceutical Services acquired Sandoz's sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada.
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Regulatory News
The agency approved AstraZeneca's Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia.
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FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company's lack of procedures to prevent microbiological contamination.
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EXCIPIENTS
The level of tastemasking required will depend on the API properties and the dosage form design.
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QUALITY SYSTEMS
Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.
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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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Catalent's global clinical supply network has eight cGMP facilities and over 50 supporting depots, managing more than 150,000 shipments per year to over 80 countries./ read more / |
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CordenPharma is your full-service CDMO in the manufacturing of APIs, drug products, and packaging services./ read more / |
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Thermo Fisher Scientific provides end-to-end development and manufacturing solutions to customers of all sizes through Patheon and Fisher Clinical Services, which deliver pharma services and clinical trials services./ 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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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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Moving Beyond the Central Dogma: New Tools and Systems for the Production of Difficult-to-Express Proteins
Wednesday, September 26, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Assessing Product Integrity Risk Profiles and Engineering On-Dose Authentication During Drug Development Process
Thursday, September 20, 2018 at 1pm EDT | 12pm CDT | 10am PDT
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Events
September 24–26, 2018
October 9–11, 2018
October 9–11, 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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