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Predicting Meaningful Process Performance
Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.
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| FDA Steps Up Foreign Inspections
New legislation and changes in policy at FDA are leading to better control of the API supply chain.
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Will Advances in Controlled Release Open Up New Drug Delivery Opportunities?
Emerging controlled-release technologies could lead to more effective therapies in the near future.
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| Mylan Rejects Teva's $40 Billion Offer
In a smoldering letter, Mylan’s executive chairman announced the unanimous rejection of a $40-billion unsolicited acquisition offer from Teva.
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| FDA Releases Final Biosimilar Guidance
FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.
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The Importance of Data Integrity in a GXP Regulated Laboratory
Live Webcast: Wednesday May 27, 2015 at 11:00 EDT; 15:00 GMT; 16:00 BST; 17:00 CET
With increased inspection scrutiny on data integrity, it is critical that managers and scientists in GXP regulated laboratories understand the current regulatory position. Discover the criteria for data integrity and learn how to assess and improve laboratory data management processes to ensure compliance with current regulations.
Register for free at
 www.pharmtech.com/pt/data
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Mylan Recalls Injectables Due to Visible Particulate Matter
Mylan announces a recall of eight lots of injectable products due to visible foreign particulate matter.
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Innate Pharma Announces $1.3 Billion Collaboration with AstraZeneca
Innate Pharma announces a co-development and commercialization agreement with AstraZeneca to accelerate the development of Innate's anti-NKG2A antibody.
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| Breaking Down Pharma Borders
With the Indian pharmaceutical industry on the rise, manufacturing businesses are working together with European and American partners to harness their longstanding experience and reputation in cleanroom manufacturing for a broader pharmaceutical manufacturing marketplace.
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 Practical Guidance for Successful Maammalian Cell Banking and Cell Line Characterization
Live Webinar: Thursday, May 14, 2015 at 8 am PDT/ 11 am EDT/ 4 pm BST/ 5 pm CEST
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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Dicerna Receives Orphan Drug Designation for PH1 Treatment
Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.
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| A Franchise Approach to the Modular Industry
Prequalified manufacturing suites could benefit from a new business model, say some industry executives.
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Biosimilars May Spur Improvements in Reference Product Manufacturing Processes
Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.
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Practical Implementation of the New Elemental Impuritites Guidelines
Live Webinar: US: Tuesday, May 5, 2015 at 11:00 am EDT | EU: Tuesday, May 12, 2015 at 15:00 AM CEST
In advance of the implementation dates, companies need to assess the risks of potential elemental impurities in their process and materials streams. In this webcast, experts review the regulatory requirements of elemental impurities guidelines, outline practical recommendations to address implementation challenges, and discuss key considerations for analytical testing programs.
Register for free at  www.pharmtech.com/pt/impurities
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Serialization: Deja Vu All Over Again?
As a special session at Interphex 2015 made clear, few pharma companies are ready for serialization and aggregation deadlines. The disconnect between pharmaceutical manufacturers and their contract partners poses a special risk.
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Hospira Recalls Bupivacaine HCl Injection
The company voluntarily recalls Preservative-Free Bupivacaine HCl Injection, USP due to potential iron oxide particulates.
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Gauging Change in Europe's Sterile Manufacturing Market
The past six months has seen some major changes to the sterile manufacturing landscape in Europe. There have been a number of exits and acquisitions that have no doubt grabbed headlines, but has anything really changed?
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Enhancing Quality and Process Efficiency
Using Continuous Manufacturing Technology
for Drug Substance and Drug Product
On Demand
 Learn More
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EMA Finds Scientific Advice Leads to Stronger Trial Design
The European Medicines Agency releases findings from marketing authorization application analysis.
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Pharmaceutical Technology presents its Analytical Testing Resource Guide combo
A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
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