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Analytical Challenges and Case Studies in Method Development for Fixed-Dose Combinations
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Effective Viral Contamination Testing Programs for Biologics Product Manufacturing
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InformEx 2015
February 03-05, 2015
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Pharmapack Europe 2015
February 11-12, 2015
Paris, France

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January 22, 2015 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE

News

Innovative Excipients in Solid-Dosage Manufacturing
This article looks at key considerations in excipient selection during formulation development and their impact on the performance of the finished drug product.
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Value-Based Healthcare in the: United Kingdom
Bio/pharmaceutical manufacturers in the UK face challenges in proving that their drugs are worth the price.
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Developing a Comprehensive Tool Kit for Microbial Identification
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Using Tocophersolan for Drug Delivery
The author gives an overview of Tocophersolan (TPGS), including its interesting properties, examples found in the literature, and a brief summary of the regulatory status and marketed formulations.
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News

Catalent and MGC Pharma Partner for Production of Cell Lines
Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.
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Pharmaceutical Technology E-Book: Analytical and Bioanalytical Testing
The editors of Pharmaceutical Technology review best practices and methods for analytical and bioanalytical testing. Topics include method transfer during scale up, viral contamination detection, analytical quality by design, screening methods for compliance with USP <232>, and validation of a bead-based multiplexed kit for quantification of nine different cytokines.
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The Quest Continues for Quality Metrics
FDA's aim is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.
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Giovanni Caforio Named BMS CEO
Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman.
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Europe Collaborates on Generic Drugs
The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.
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EFPIA and IMI Announce New Projects to Fight Ebola
Eight new projects will focus on the diverse needs of the Ebola epidemic, such as new vaccine development, production and distribution, and new diagnostic methods.
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Enhancing Quality and Process Efficiency using Continuous Manufacturing Technology for Drug Substance and Drug Product
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Catalent and Sanofi to Collaborate on ADC Development
Catalent Pharma Solutions and Sanofi-Aventis R&D have entered into a collaboration to develop Sanofi's proprietary antibodies using Catalent's SMARTag antibody drug conjugate (ADC) platform.
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USP Elemental Impurities Implementation Set for January 2018
USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.
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Boehringer Ingelheim Partners with Vanderbilt University to Develop Ras Inhibitors
Boehringer Ingelheim announced that it would partner with Vanderbilt University to research and develop Ras inhibitors for the treatment of cancers affected by Ras mutation.
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Coquí RadioPharmaceuticals Plans Construction of Mo-99 Facility
Coquí RadioPharmaceuticals announced that it met an agreement with the University of Florida Foundation to acquire 25 acres of land to build a medical isotope facility.
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Eli Lilly Enters into Collaborations for Cancer Treatments
Eli Lilly collaborates with Bristol-Myers Squibb and Merck on clinical trials of oncology treatments.
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Sanofi Forms Strategic Pact with Boehringer Ingelheim for Biologics Manufacture
Sanofi has entered into a strategic manufacturing collaboration with Boehringer Ingelheim for the manufacture of therapeutic monoclonal antibodies (mAbs).
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Industry Veteran Tom Tappen Remembered by Colleagues
Tom Tappen, who passed away Jan. 1, 2015, is remembered for contributions to the pharma industry, customers, and business associates.
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News
Analytical and Bioanalytical Testing eBook 2014
View technical articles on the best practices and methods for analytical and bioanalytical testing including method transfer during scale up, viral contamination detection, and analytical QbD, as well as a roundup of analytical technology.
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Podcasts
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Pharmaceutical Technology Drug Delivery Guides
A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects.  Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
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