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Top Stories
Bayer received conditional approval from the Antitrust Division of the United States Department of Justice to acquire Monsanto in a deal worth $66 billion.
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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.
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Industry News
The agency issued guidance on over-the-counter topical drug products that address maximal usage trials.
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Internationalization and regulatory reform are driving growth and investment China.
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Supplier News
In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.
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GEA and Perceptive Engineering will collaborate to promote and deploy multivariate monitoring and advanced process control (APC) solutions for batch and continuous pharmaceutical process units.
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Bio/Pharma News
The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.
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The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.
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Analytical Procedures & Methods Validation Europe provides a comprehensive understanding of regulatory trends and requirements, “hands-on” training for executing procedures that survive the lifecycle and solutions to challenges within the laboratory.
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Regulatory News
The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson's blockbuster Remicade (infliximab).
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IVT's Stability Testing Europe allows attendees to review core FDA and ICH guidance to breaking down the latest regulatory policies, including a brand new updated WHO draft guidance for API and finished drug stability testing. Don't miss the chance to participate in hands-on training for small molecules, biologics and medical devices to harmonize global systems and enhance stability programmes.
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PEER-REVIEWED RESEARCH
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.
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June 4–7, 2018
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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. |
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