Top Stories
Wyeth reaches agreement in principle to resolve Medicaid drug rebate claims for 2001-2006 period for Protonix.
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FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.
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The  2016 PDA Annual Meeting provides the latest and most comprehensive information about innovative biopharmaceutical approaches, bioprocessing technologies and manufacturing sciences for development and commercialization. Learn how accelerated product development, expanding access to medicines and personalized treatments will impact the future of manufacturing. Opportunities abound to network with industry and regulatory experts and colleagues from around the world.
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Industry News
Growth in finished dosage formulations triggers a new CPhI Worldwide event.
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3M Drug Delivery Systems, Ei Solutionworks, IDT Biologika join CMO/CDMO association.
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Supplier News
Ashland Chemical's Calvert City, KY, facility is the first in the US to receive EXCiPACT certification for GMPs of pharmaceutical excipients.
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Innovations awarded at Pharmapack Europe include improvements for patient compliance and protection from errors, tampering, or misuse.
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Cost Effective Solutions to Develop and Manufacture Product
INTERPHEX is a premier pharma, bio and medical device development and manufacturing event dedicated to Innovation, Technologies and Knowledge throughout the full product development life cycle. Join us in New York, April 26-29, 2016. Register for your complimentary Technical Education and Exhibit Hall Pass Today at  www.INTERPHEX.com/Register. Discover what's NEW at #INTERPHEX. |
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Bio/Pharma News
Sandoz reveals plans to complete a Phase III development program for Pfizer's infliximab biosimilar and file for registration in the EU.
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Sartorius announced the release of the company’s new Tacta pipettes.
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Regulatory News
There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.
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The agency prepares a plan to implement new packaging safety features.
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Technology Transfer from a CDMO Perspective
Joe Cobb, CPIP, director of pharmaceutical development at Metrics Contract Services, recently shared industry challenges from the contract manufacturing side of the industry on tech transfer, which continues to be one of the main challenges of the pharmaceutical industry when it comes to outsourcing.  Learn more and view Cobb's presentation at metricsinc.com. |
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FEATURED TOPICS |
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OUTSOURCING
Heightened global uncertainty could slow bio/pharma development activity.
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FORMULATION
The reporter bioassay, used to evaluate ADCC activity of therapeutic antibodies, complements the classical ADCC assay.
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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
LIVE WEBCAST: Wednesday, March 23, 2016 at 8 am PDT / 10 am CDT / 11 am EDT
Join this informative webinar to learn how to foster relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny.
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Webcasts
On Demand
Calibration, qualification, and the right appropriate level of routine testing for laboratory instruments are critical to ensuring high-quality results and maintaining GMP and USP compliance. Understand the relationship between these factors to optimize testing and be prepared for audit.
Sponsored by Mettler Toledo
On Demand
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
Sponsored by Patheon
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Best Practices for Effective Product Transfer
ON-DEMAND
Understanding all aspects of the product transfer process is critical to a successful transfer and delivery of a quality product. During this one-hour webinar, regulatory and pharma experts will discuss the critical elements and processes needed for an effective, compliant product transfer process and successful end results.
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on pharmtech tv
User-Friendly Dosage Forms
Cleaning Validation
Prefilled Syringes for Clinical Trial Use
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Events
February 21-25, 2016
March 14-16, 2016
April 26-28, 2016
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REFERENCE BOOKS |
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Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
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More Reference Library |
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eBOOKS
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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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