Top Stories
The move follows a warning from FDA wherein FDA cited ALK-Abello with numerous manufacturing violations.
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The Phase I trial will test Bavarian Nordic's vaccine, which is manufactured using a vaccine vector based on smallpox.
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John C. Lechleiter will step down from his post as CEO of Eli Lilly effective December 31, 2016.
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Industry News
NIST's monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.
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An MIT-developed system uses microbes for manufacturing small amounts of vaccines and other therapies.
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EXPERT INTERVIEW
David Mayers, president of Wellspring Pharma Services sat down with Pharmaceutical Technology to discuss the manufacture of controlled substances.
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Supplier News
The new materials handling laboratory will be used for storage, dispensing, inventory management, and distribution of non-GMP materials.
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The company announced that its facilities and laboratories have completed FDA pre-qualification inspection.
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Bio/Pharma News
Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.
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The acquisition will add to the company's cell therapy base and potential impact in treating rare diseases.
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Regulatory News
FDA and industry seek speedy Congressional approval of new user fee plan.
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The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.
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New Trends in Hygienic Diaphragm Valves that Improve Reliability
LIVE WEBCAST: Thursday, September 22, 2016 at 11:00 am EDT
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STANDARDS AND REGULATIONS
The impact of pharmaceutical manufacturing on the environment has triggered demands for tighter environmental controls in EU and national legislations.
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FORMULATION
Lipid-based drug delivery is increasingly being used to tackle oral bioavailability challenges resulting from poor solubility.
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Sustained-Release Formulation: Overcoming Key Challenges Like Alcohol-Induced Dose Dumping
LIVE WEBCAST: Tuesday, September 13, 2016 | 11 am EDT | 10 am CDT | 8 am PDT
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OUTSOURCING
CDMOs need to be aware that unfavorable public markets put emerging bio/pharma R&D spending at risk in 2017.
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MANUFACTURING
A seven-step process may reduce many common tablet and tooling problems, resulting in a better quality end product.
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Understanding the Relationship between Critical Quality Attributes and the Microstructure of Topical Semi-Solid Formulations
LIVE WEBCAST: Thursday, September 8, 2016 at 11 am EDT | 10 am CDT | 8 am PDT
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Webcasts
On Demand
What drives a pharmaceutical company to scrutinize an instrument manufacturer and every detail of the instrument during instrument qualification? The answer is simple, compliance. Every company that produces pharmaceutical products must guarantee a consistent quality product that meets regulated specifications for the entire product life cycle, from production to consumption. What happens when that compliance falls short? A review of inspection citations from 2015 can help you learn from the mistakes of others. Learn about solutions to decrease the likelihood of receiving an FDA Form 483.
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The Advantages of a Employing a Lipid-Based Formulation Process in Early Development
On Demand
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On Demand
As single-use systems gain wider use in biopharmaceutical manufacturing, drug owners must understand the risk of potential contaminants from plastics interacting with the drug. Establishing clearly defined standards for acceptable testing protocols and has proven difficult. In this webcast learn about available guidance documents, a risk-based materials qualification process for extractables and leachables studies; and the value of standardized and custom testing protocols.
Sponsored by SGS
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Bio/Pharma in China
New Initiatives, New Opportunities
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Events
August 17-18, 2016
September 12-14, 2016
September 18-21, 2016
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REFERENCE BOOKS |
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A compilation of articles Pharmaceutical Technology 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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eBOOKS
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Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems. |
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