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Top Stories
Catalent's new Biologics & Specialty Drug Delivery unit will be led by Barry Littlejohn; Jonathan Arnold to lead Oral Drug Delivery.
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This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.
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The companies aim to use CureVac’s proprietary messenger RNA technology to develop and commercialize up to five potential cancer vaccine products.
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PharmTech 2017 Employment Trends
The editors of Pharmaceutical Technology invite you to participate in the annual employment survey for individuals involved in bio/pharmaceutical development, formulation, or manufacturing.
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Industry News
The company is recalling several injectable products because of possible microbial contamination.
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The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.
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Supplier News
The company has announced that it has acquired a new bioanalysis and biomarkers services facility in Laval, Montreal, Canada to support preclinical and clinical programs.
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The companies will embark on a joint antimicrobial research project, with the intent to discover antibiotic combinations that target resistance.
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The bottle-top dispenser Dispensette® S is the new generation of BRAND dispensers. Both Dispensette® S and Dispensette® S Organic models cover a broad range of applications for dispensing aggressive reagents and organic solvents - directly from the supply bottle. The bottle-top dispensers Dispensette® S and Dispensette® S Organic satisfy the requirements of the ISO 8655 and are fully autoclavable at 121°C.
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Bio/Pharma News
The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.
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The $72-million investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.
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Regulatory News
The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.
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EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.
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Quality
Lawrence Yu, deputy director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), and his FDA colleague, Michael Kopcha highlight the importance of Six Sigma approaches to continuous improvement in the pharmaceutical industry.
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Formulation
Applying the right formulation strategies early in the drug development process can help avoid costly late-stage failures.
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Supply Chain
Internet of things, advanced analytics, and blockchain solutions such as smart contracts promise to give manufacturers more control over products and supply chains.
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New Products and Services
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Albemarle Corporation’s Fine Chemistry Services business has more than 40 years of experience, dedicated to custom manufacturing.
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Contec, Inc. is a leading manufacturer of contamination control products for mission-critical cleaning in manufacturing environments worldwide.
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Ross Dual-Shaft Mixers, suitable for mixing 50-, 100-, and 200-gallon batches, are equipped with two independently-driven, variable-speed agitators: a high-speed disperser and a two-wing anchor.
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The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community.
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VAI’s manufacturing and testing operations mirror current GMP/GLP standards.
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Events
October 29–November 1, 2017
October 31–November 2, 2017
November 6–8, 2017
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eBOOKS
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New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics. |
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