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Top Stories
The FDA commissioner outlined the agency’s initiatives to reward innovation and biosimilars development.
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The government is exploring terms by which the UK could still be part of EMA after its departure from the EU, Theresa May said in a key speech on Brexit.
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Industry News
GlobalData reports the need to shift away from egg-based manufacturing of vaccines in light of influenza-related deaths.
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The company is recalling Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g manufactured by Gland Pharma Ltd and distributed by Sagent due to out-of-specification impurity results.
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Biopharma News
The pharma major will spin out six molecules in early stage inflammation and autoimmune programs into a new company called Viela Bio.
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Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.
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Supplier News
Grand River Aseptic Manufacturing announces first planned investment in capacity expansion.
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Catalent completes $4.6 million expansion at Singapore clinical supply facility and marks 20 years in the region
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Regulatory News
The agency has approved a new HIV treatment for patients with "limited treatment options".
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The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen’s multiple sclerosis drug Zinbryta (daclizumab beta).
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OUTSOURCING
Development and adoption of new technologies create challenges that may take years to resolve.
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DISPOSABLES ADVISOR
Material compatibility, material sourcing, facility layout, and training are crucial aspects of a successful disposable fill-finish system.
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INTERPHEX Exhibitor Guide
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Distek Inc. has developed a benchtop scale single-use bioreactor (SUB) system for mammalian cell growth and recombinant protein production.
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By exploiting the strong synergies in bioreactor technology and polymer manufacturing, Eppendorf has emerged as a global player in the bioprocess marketplace.
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Getinge Life Science offers equipment and services for biopharma production, biomedical research, and lab facilities.
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Hamilton Company introduces ArcAir—a new communication package for its Arc family of intelligent process sensors.
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BioProfile FLEX2 is the only cell culture analyzer designed for manual, at-line and online sampling of bench-scale bioreactors and integration with the automated ambr® 15 and 250 cell culture microbioreactor systems.
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Take the survey
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Participate in BioPlan's 15th Annual Global Biopharmaceutical Manufacturing Study. Share your insight on current global and regional trends affecting biomanufacturing and BioPlan will donate $15 (up to $2,000) on your behalf to global health charities. Participants also receive a free aggregated summary of this year's results and an updated 15 Top Trends in Biopharmaceutical Manufacturing White Paper. |
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Events
March 19–22, 2018
March 20–21, 2018
March 26–27, 2018
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eBook
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.
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