Samsung Biologics expands with $2B S. Korea plant | Barcodes, IoT sensors can prevent vaccine losses | 4 ways AI and data help smart manufacturing
August 13, 2020
ISPE SmartBrief
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Process development and manufacturing
Samsung Biologics is building a $2 billion manufacturing plant in Incheon, South Korea, as the company has seen a 150% increase in orders during the first half of 2020. The company is also planning a separate facility that will serve as an innovation center.
Full Story: FiercePharma (8/11) 
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Facilities and equipment
Barcodes, IoT sensors can prevent vaccine losses
A worker transports vaccines at a Sanofi warehouse. (Joel Saget/Getty Images)
Internet of things sensors attached to pallets of vaccines can alert manufacturers of temperature changes that could degrade vaccines, while scannable barcodes can also provide critical data. Drug manufacturers are also paying close attention to cold storage as they prepare to deliver COVID-19 vaccines.
Full Story: Supply Chain Dive (8/11) 
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Information systems
Artificial intelligence can process more engineering design options at the conceptual stage than humans, which is one of four ways AI and big data can improve manufacturing, Beth Stackpole writes. "Where machines bring their strength, repeatability, and precision, humans can bring their flexibility, judgment, and dexterity," says Veo Robotics Chief Technology Officer Clara Vu.
Full Story: Ideas Made to Matter (MIT Sloan School of Management) (8/11) 
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Supply chain management
The International Air Cargo Association and Pharma.Aero are producing air cargo industry guidelines for transporting COVID-19 vaccines. The guide, which is expected to be ready by the end of the year, will cover handling, storage and tracking requirements for COVID-19 vaccines.
Full Story: European Pharmaceutical Review (UK) (8/12) 
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The US government signed a contract worth around $1.5 billion with Moderna to acquire 100 million doses of its potential COVID-19 vaccine. Moderna's experimental vaccine, mRNA-1273, has already reached the final stage of testing and is expected to be completed next month.
Full Story: Reuters (8/11) 
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Qiagen Manchester, a subsidiary of Qiagen, has entered a 10-year commercialization and distribution agreement with HTG Molecular Diagnostics that will offer biopharmaceutical firms global distribution, development and commercialization capabilities for companion diagnostics that are based on HTG's EdgeSeq technology.
Full Story: Seeking Alpha (free registration) (8/11) 
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Quality and regulatory issues
FDA Commissioner Stephen Hahn, speaking at the Reagan-Udall Foundation's virtual meeting, reassured participants that approval decisions for a COVID-19 vaccine "will continue to be based on good science and the same careful, deliberative processes which we have always used when reviewing medical products." The FDA chief also unveiled a new initiative, dubbed the Pandemic Recovery and Preparedness Plan, or PREPP, designed to "help systematically review FDA's actions to date and identify lessons learned."
Full Story: Regulatory Focus (8/11) 
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The FDA has issued a draft guidance on how to assess drug-drug interactions for therapeutic protein candidates licensed as therapeutic biological products. Drug firms developing a therapeutic protein should use a "systematic, risk-based" method to determine whether they need to perform DDI studies, and when considering the potential DDIs, they must take into account the potential mechanisms for DDIs between therapeutic proteins or between small molecules and TPs, according to guidance.
Full Story: Regulatory Focus (8/10) 
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Research and development
Mexico inks MOUs with J&J, CanSino for COVID-19 vaccine trials
(Mark Ralston/AFP/Getty Images)
Mexico announced that memorandums of understanding have been signed with Johnson & Johnson and China's CanSino Biologics and Walvax Biotechnology to conduct Phase III trials for their respective investigational COVID-19 vaccines, according to Foreign Secretary Marcelo Ebrard. CanSino and Walvax could also base their vaccine production in Mexico as well.
Full Story: Reuters (8/11) 
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The NIH has awarded a $1.86 million grant to the Department of Physics and Astronomy at the University of California at Riverside for a study of how pathogens evolve. "We are most interested in viruses like HIV, but in principle, the methods that we're working on could be applied to many different types of evolving populations," says researcher John Barton.
Full Story: University of California, Riverside (8/10) 
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Patient perspective
Thousands of people worldwide have added their names to registries of volunteers for SARS-CoV-2 vaccine challenge trials, but some bioethicists and physicians say too much is unknown about the novel coronavirus, too few effective treatments exist, and the pace of vaccine research for it make challenge trials especially risky. "We are moving along quickly through traditional Phase III clinical trials, and we're already facing a headwind with public trust, given how fast that process is going," said FasterCures Executive Director Esther Krofah.
Full Story: Medscape (free registration) (8/7) 
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ISPE update
ISPE announced its 2020 ISPE Europe Annual Conference, taking place virtually 15-16 September 2020, will feature a diverse mix of global health authorities providing insights COVID-19. Twenty regulatory experts representing ten countries will share perspectives and lessons learned on the pandemic impacting drug shortages, distant assessments, and good manufacturing practices (GMP) reliance.
Full Story: ISPE/Pharmaceutical Engineering (8/2020) 
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Featured in this edition of iSpeak Reading Roundup, are the top blog posts from July 2020. Discover key insights on agile software development, best practices for maintaining pharma supply chain continuity, and more.
Full Story: ISPE/iSpeak (8/12) 
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1935-2020
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