April 22, 2021
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Top story
Deer roam through the forest surrounding BioNTech's new production facility in Marburg, Germany, where about 400 employees produce millions of COVID-19 vaccine doses each week. The 50,000-step process starts inside a 50-liter stainless-steel bioreactor, products move from one stage to the next through hermetically sealed plastic tubing, and bags of bulk product are shipped to Baxter's fill-and-finish facility 120 miles away in Halle.
Full Story: TIME (tiered subscription model) (4/19) 
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Process development and manufacturing
South Korean biopharmaceutical companies increasingly see contract drug manufacturing as a long-term growth engine, and both Samsung Biologics and SK Group have been investing globally. South Korea's pharmaceutical industry has been shifting from synthetic drugs to biopharmaceuticals and from generics to research and development, increasing demand for contract manufacturing capacity.
Full Story: Korea Biomedical Review (4/19) 
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Multiparticulate technology offers makers of complex drugs flexibility in dosing for controlled or extended release, and Pfizer's multiparticulate extrusion-spheronization platform is designed to deliver highly specialized medicines, writes Pfizer's Jacintha Griffin. The process involves dry blending, wet granulation, extrusion, spheronization and pellet drying, followed by pellet coating if required.
Full Story: European Pharmaceutical Manufacturer (4/19) 
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The United States Pharmacopeia is expected to release a chapter next month on determining water activity, or Aw, in pharmaceuticals that includes a theoretical background explanation, best practices and an overview of potential applications, such as stability control and microbial risk prevention. "Water activity has the potential to eliminate many safety and quality-related issues in pharmaceutical products, resulting in less waste and higher revenue," said Brady Carter, a scientist with expertise in Aw.
Full Story: European Pharmaceutical Review (UK) (4/19) 
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2021 Trends in Quality Analytics
2020 reinforced the importance of connected quality data in the industry's march towards digitization. Download "Novelty Becomes Necessity: 2021 Analytics Trends" to learn how you can use this data to improve your analytics and enhance visibility.
Facilities and equipment
Virginia Commonwealth University's College of Engineering presented the results of a yearlong planning process to turn the Richmond-Petersburg area into a hub for pharmaceutical manufacturing, research and development. Recommendations include working with local community colleges to train pharmaceutical plant technicians, establishing a translational R&D center and a national center of excellence for continuous pharmaceutical manufacturing, and forming a regional council to coordinate activities.
Full Story: Virginia Business (4/20) 
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Industrial and systems engineers at the University of Southern California have developed an inexpensive, reusable support system for 3D printing that could save energy and reduce waste. The prototype works by moving individual supports with a single motor that moves a platform, and it reduced materials usage by approximately 35%, which could result in significant savings in biomedical additive manufacturing, says lead researcher Yong Chen.
Full Story: Plant Engineering (4/15) 
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Featured Content
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Information systems
Siemens will upgrade its factory automation efforts through data collected by Google Cloud and Google's artificial intelligence and machine learning technology. Manufacturers are predicted to gain from their use of Siemens' Digital Industries Factory Automation offerings.
Full Story: Electronics Weekly (UK) (4/19) 
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Supply chain management
AstraZeneca was unable to meet demand in the EU for its COVID-19 vaccine early this year due to a shortfall at a Halix plant in the Netherlands, and drug substance shipped from a Catalent plant in the US to Italy for filling and finishing could not make up for the shortfall, according to EU documents obtained by a Belgian news organization. A plant in Belgium originally owned by Henogen that is also producing drug substance for the vaccine has met its obligations and installed new equipment to boost capacity, and AZ is likely to seek approval of contract manufacturing plants in South Korea and China.
Full Story: Politico (4/20) 
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US Sen. Marco Rubio, R-Fla., reintroduced the Medical Manufacturing, Economic Development, and Sustainability Act, meant to encourage drugmakers to relocate to the US and offer a tax credit for relocating in economically distressed areas. Rep. Jenniffer Gonzalez-Colon, R-Puerto Rico, reintroduced companion legislation in the US House.
Full Story: Florida Daily (4/21) 
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Quality and regulatory issues
Emergent BioSolutions' Baltimore facility failed to train workers adequately to prevent cross-contamination of bulk drug substances, correctly handle waste and keep the plant clean and sanitary, and it is "not of suitable size, design, and location to facilitate cleaning, maintenance, and proper operations," according to a US FDA inspection report. The plant had been making bulk drug substances for AstraZeneca's and Johnson & Johnson's COVID-19 vaccines under a US government contract, and J&J is working with Emergent to resolve quality issues.
Full Story: NBC News (4/21),  CNBC (4/21) 
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ISPE update
In this clip, hear from Frances Zipp, Co-Chair of the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference, President & CEO, Lachman Consultant Services, Inc., as she answers the question: What are the biggest challenges for Asia Pacific region companies in implementing consistent/sustainable quality risk management? Watch Now: ISPE
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No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference presentations from 2020, hand-selected the absolute best and brightest, and packaged it into the ISPE Best of Pharma Series. Access the most premier presentations offering compelling insights, strategies, and best practices from experts representing global health authorities and leading pharma organizations. View Presentation Titles: ISPE
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