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TOP STORIES
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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The Coalition for Epidemic Preparedness Innovations will invest up to $384 million of additional funding, in addition to the $4 million it invested in March, to advance the clinical development of NVX-CoV2373, Novavax’s COVID-19 vaccine candidate.
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Featured Resources from BioPharm International
View our online resource center, sponsored by GE Healthcare, to explore a case study and articles on gaining and retaining skilled labor, modular bioprocessing, the good and bad of biosilimiars, and more.
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SubscribeSubscribers can enjoy each full issue of BioPharm International in print, or via BioPharm apps.
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Industry News
Michelle McMurry-Heath will assume the role of BIO president and CEO on June 1, 2020 after Jim Greenwood, who has led the organization since 2005, retires from the positions.
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The Center for iPS Cell Research and Application Foundation and the Cell and Gene Therapy Catapult have announced the launch of a new collaborative research project that will focus on induced pluripotent stem cell characterization.
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Biopharma News
Santen Pharmaceutical has concluded a licensing agreement with jCyte for the development, registration, and commercialization rights to jCell, an investigational retinitis pigmentosa therapy, in Japan, Asia, and Europe.
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Hitachi Chemical Advanced Therapeutics Solutions and apceth Biopharma entered into long-term development and manufacturing services agreements for the clinical and commercial supply of multiple bluebird bio therapies.
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Supplier News
Through the agreement, Mylan will manufacture and distribute remdesivir in 127 low- and middle-income countries, including India.
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The company will invest $180 million to construct a new 290,000-ft2 facility in Plainville, MA
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Regulatory News
The agency is responding to companies promoting and selling medical products that claim, but are unproven, to prevent or treat COVID-19.
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A high-level meeting on COVID-19 policies, organized by EMA under the auspice of the International Coalition of Medicines Regulatory Authorities (ICMRA), has brought together global regulators to ensure a coordinated pandemic response.
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FEATURED TOPICS |
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MANUFACTURING
The industry’s aversion to risk has led to its treating closed aseptic processing systems as miniature cleanrooms, resulting in redundant and expensive practices. This article ponders this impasse, examining new technologies and applications in light of past regulatory guidance and more than 40 years of operating evidence.
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ON DEMAND WEBCASTS
From Small-Scale Stem Cell Production to Large-Scale hiPSC-Based Drug Development: The Flexibility of Stirred-Tank Bioreactors
On Demand Webcast
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WEBCASTS
Practical Method Development Strategies for the Analysis of Monoclonal Antibodies by Reversed-Phase HPLC
Thursday, May 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Vaccines Illuminated: Biophysical Characterization, PAT, and Quality Control via Light-Scattering Techniques
Tuesday, May 19, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Accurate Weighing of Reference Standards in a QC Laboratory
Thursday, May 28, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST
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Viral Vector Process Development:
Applying CE and MS Techniques for In-Process Testing
Wednesday, May 27, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Innovation, Collaboration, and Technology Development - Leveraging the Thermo Fisher Ecosystem to Accelerate Platform Improvements in Biopharmaceutical Manufacturing
Wednesday, May 27, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Validation of an LC-MS Multi-Attribute Method (MAM) Supporting Biopharma Process Characterization
Tuesday, June 30, 2020 at 10am EDT | 9am CDT | 2pm BST | 3pm CEST
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Rescheduled Events
CPhI South East Asia has been rescheduled for July 2020.
PDA’s Annual Meeting has been rescheduled for July 2020.
Bioprocessing Summit Europe has been rescheduled for July 2020.
PDA’s Pharmaceutical Manufacturing Data Science Workshop has been rescheduled for July 2020.
CPhI North America has been rescheduled for September 2020.
CPhI Japan has been rescheduled for September 2020.
Analytica 2020 has been rescheduled for October 2020.
Interpack 2020 has been rescheduled for February 2021.
Interphex 2020 has been rescheduled for April 2021.
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eBook
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The Pharmacopoeia Compliance Series features a description of ways biopharma companies can participate in monograph development, a case study of a practical approach to pharmacopoeial compliance, and a summary of this 12-part series.
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