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FDA plans to initiate its quality metrics program as industry continues to push back.
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The industry is becoming more consolidated, but there needs to be some strategy behind the mergers and acquisitions.
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INTERPHEX 2017 Keynote Series
A New ASTM Standard for Cleaning Validation
This presentation will introduce the "Standard Guide for Science and Risk-based Cleaning Process Development and Validation" a standard guide in the final stage of approval in the American Society for Testing and Materials (ASTM).
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Industry News
The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.
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The district court ordered Pick and Pay Inc./Cili Minerals to cease operations after it unlawfully manufactured and distributed unapproved new drugs, misbranded drugs, adulterated dietary supplements, and misbranded dietary supplements.
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Supplier News
Thermo Fisher Scientific will provide cryo-TEM for small-molecule and biologic drug discovery.
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The company opened a new bioconjugation unit to support the clinical and commercial manufacturing of ADCs.
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Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers
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Bio/Pharma News
Sarepta sold the priority review voucher for Exondys 51, a controversial treatment for Duchenne Muscular Dystrophy, to Gilead.
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Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.
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Regulatory News
Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.
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The agency cited the company's Kansas facility with CGMP violations similar to problems found at other Hospira facilities.
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ANALYTICS
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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FORMULATION
More agile techniques are improving the development of multiparticulate drug-delivery systems.
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SUPPLY CHAIN
An example of a new cold chain temperature-controlled shipping technology is Cocoon, which was commercialized in November 2016 and designed for use with pallet-sized shippers.
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Events
March 20–23, 2017
March 21–23, 2017
March 22–24, 2017
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REFERENCE BOOKS |
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Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
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eBOOKS
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Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain. |
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