Pharmaceutical companies and their contractors are reorganizing their manufacturing lines and logistics to ensure compliance with the serialization requirements, but many SMEs are struggling to meet the deadline. / read more /
Bayer received conditional approval from the Antitrust Division of the United States Department of Justice to acquire Monsanto in a deal worth $66 billion. / read more /
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FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity. / read more /
World Health Organization's Ebola ring vaccination uses Merck & Co.'s investigational rVSV-ZEBOV vaccine to protect high-risk communities in the Democratic Republic of the Congo from Ebola. / read more /
The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support. / read more /
The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases. / read more /
The UK's University of Sheffield opened a new chemical engineering teaching plant for continuous oral solid-dosage pharmaceuticals using GEA’s multipurpose platform. / read more /
Ready-to-use components eliminate the need for component preparation by the drug product manufacturer, enabling them to streamline their processes and focus on their core competencies, such as drug product development and manufacturing. / read more /
The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated. / read more /
Choosing the right contamination control platform requires considerable research into what a product needs for an effective process design. / read more /
Advanced data analytics tools are used by industry to find the golden nuggets in historical data, to aid in process development, to fine-tune production, and to achieve long-term improvements in product quality and throughput. / read more /
Midilab RC
Midilab RC is Diosna's modular laboratory equipment that offers a fluid bed and a tablet coater module for a flexible production. Different batch sizes and a rapid change between the modules are just some of the benefits.
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This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.
