February 2016
Volume 12 Issue 2
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Supply Chain Update
With less than two years to meet the US deadline, both manufacturers and CMOs have to move quickly to implement serialization practices.
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Expanded systems integration, serialization, and supply chain connectivity will enhance productivity and support counterfeit prevention.
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Bioprocessing and Sterile Manufacturing eBook
Articles in Pharmaceutical Technology's Bioprocessing and Sterile Manufacturing ebook examine novel technologies for the development, manufacture, purification, and delivery of small- and large-molecule drugs, including single-use systems, lyophilization, and microbial monitoring. Aging facilities and the future of aseptic processing are featured topics.
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GS1 US announces the expansion of its advisory services program to address industry needs.
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Siemens and ADENTS develop joint solution for drug serialization challenges.
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API Synthesis and Manufacturing
Nanoscale catalysts and engineered nanoparticles show promise for API synthesis and delivery.
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FDA issued a warning letter to Chan Yat Hing Medicine Factory for cGMP violations.
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FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.
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ExcipientFest Americas, the leading international event devoted to scientific, regulatory and sourcing developments in Excipient technology, returns to Baltimore, MD to celebrate IPEC Americas 25th Anniversary on April 25-27, 2016. This two-day Conference & Expo offers the opportunity to meet suppliers, make great business connections and attend to unparalleled educational sessions in one event.
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Regulatory Update
FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.
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Outsourcing Outlook
Industry experts discuss recent industry consolidation and what the outsourcing market holds for 2016.
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Contract Services Update
Planned expansion at Onyx Scientific add laboratories, GMP suites, and storage space.
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Vetter announces completion of multi-functional building for development service and IT functions.
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Patheon announced the appointment of Gilles Cottier as president of the company’s pharmaceutical development services.
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Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.
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Hermes Pharma has commercially implemented hot-melt coating (HMC) technology at its production facility.
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SGS Life Sciences expands chemistry and microbiology testing services after acquisition of Quality Compliance Laboratories.
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Aesica Pharmaceuticals announced on Jan. 19, 2016 that the company has relocated development and clinical manufacturing services to Queenborough.
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The collaboration will focus on development of novel molecules using SMARTag technology to couple different therapeutic modalities.
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Charles River Laboratories entered into a definitive agreement to acquire WIL Research.
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