October 14, 2021
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Top story
Disruptions in the global supply chain will worsen before improving, leading to higher prices and a slower economic recovery, according to Moody's Analytics. A shortage of truck drivers, bottlenecks at ports, differences in how countries are responding to COVID-19 and the lack of a coordinated global logistics and transportation effort are all contributing to the problem, according to Moody's; however, JPMorgan Chase CEO Jamie Dimon predicts the worst of the supply chain problems will be over by next year.
Full Story: CNN (10/13) 
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5 ways to avoid data integrity issues
Companies that can identify, remediate, and prevent data integrity issues will have a distinct advantage over those that continue to let data and procedures go unchecked.
Get 5 strategies for avoiding and proactively addressing the data integrity issues that lead to 483s and warning letters.
Process development and manufacturing
Organizations in high-hazard industries can use a "chronic unease" attitude that promotes awareness, vigilance and ongoing reassessment of safety culture and practices, write Richard Smith and Mike Snyder of DEKRA. In a culture of chronic unease, weak safety warnings are noticed, communication channels are open and risks are discussed and addressed, but it shouldn't be allowed to morph into paralyzing anxiety, they write.
Full Story: IndustryWeek (10/11) 
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Chapter 1220 of the US Pharmacopoeia and National Formulary, which goes into effect May 1, establishes a life cycle approach to analytical method development and defines useful concepts to facilitate changes after a drug has been approved. The analytical target profile is fundamental to the life cycle approach and involves understanding the effect of procedure parameters on procedure performance, certifying that performance characteristics meet established criteria and monitoring the method's performance.
Full Story: Regulatory Focus (10/11) 
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Astellas has started using blister packaging made from biomass-based plastics using sugarcane-derived polyethylene, the first of its kind in the world. The company's adoption of biomass-based plastics for its blister packages is one of Astellas' strategic goals in its Corporate Strategic Plan 2021 known as "Deepen our Engagement in Sustainability."
Full Story: European Pharmaceutical Review (UK) (10/11) 
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Interactive Q&A: Streamlined Tech Transfers
November 9th - 10am EST/3pm GMT
Learn best practices and hear real-world experiences that produce more comprehensive and efficient technology transfers in a live Q&A format. Panelists include Paul Denny-Gouldson (Zifo RnD Solutions), Joschka Buyel (Bayer Pharmaceuticals), and Yash Sabharwal (CherryCircle Software). Register Now
Facilities and equipment
Biopharmaceutical facility designers must consider applicable building codes as well as international regulations for safety and waste handling, the need for flexibility, product and process risks, and process workflows, write engineers Herman Bozenhardt and Erich Bozenhardt. "The production process includes all aspects of the operation, including personnel flow, product flow, raw material flow, waste/trash flow, spill removal, facility cleaning, and equipment flow and maintenance," they write.
Full Story: Bioprocess Online (10/11) 
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Boehringer Ingelheim's newly opened large-scale cell culture facility in Vienna features smart technologies and artificial intelligence, according to the drugmaker, which invested $810 million in the facility. The facility has a capacity of 185,000 liters, employs 500 workers and will produce molecules for Boehringer's own product portfolio as well as third parties.
Full Story: BioPharmaReporter (10/11) 
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BioTechnique moved equipment and staff from Wisconsin to a 160,000-square-foot facility in York, Pa., where Unilife once had a pharmaceutical manufacturing facility. Around 100 workers are expected to be hired at the facility over the next three years.
Full Story: WHTM-TV (Harrisburg, Pa.) (10/14) 
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Supply chain management
Moderna will not share the formula for its COVID-19 vaccine with other manufacturers as it has determined that scaling up its own production is the best solution to boosting global supply, said co-founder and Chairman Noubar Afeyan. The company also said it plans to deliver a billion doses of its coronavirus vaccine to low-income countries next year, aside from doses already committed to COVAX.
Full Story: The Associated Press (10/11),  Reuters (10/8) 
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Biopharmaceutical industry supplier High Purity New England is investing $10 million in a new facility that will triple its output and house a sixth cleanroom, a lab, office space and a distribution center. The company, which supplies pumps, single-use bioreactors and sterilized storage bottles, has seen annual sales quadruple in 2021, and sales manager Matt Sitcoske expects to have 350 employees by the end of next year, growing from 60 employees in 2019.
Full Story: Endpoints News (free registration) (10/8) 
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Quality and regulatory issues
The European Union is considering options for reducing the bloc's reliance on China and other countries for drugs and pharmaceutical ingredients, and may be updating laws "to address shortages in areas like harmonized reporting, stronger obligation of supply and greater transparency in the supply chain," EU Health Commissioner Stella Kyriakides said. Any new laws or regulations would not be proposed until December 2022 and may include incentives in exchange for stricter supply obligations, along with requirements for drugmakers to have crisis plans and warn the EU of potential supply disruptions.
Full Story: Reuters (10/12) 
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ISPE update
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. LEARN MORE: ISPE
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This is a very special category that the FOYA Judges deemed important during such an unprecedented year, not only because of the impact the COVID-19 pandemic had on the pharmaceutical industry but because of the impact it had on the entire world. Facility of the Year Awards (FOYA) Operational Agility: COVID-19 Impact Category winners are receiving special recognition for their operational agility to make progress and/or impact the efforts for therapies and vaccines to combat the pandemic. Grand River Aseptic Manufacturing is one of two companies that was awarded a FOYA in Operational Agility: COVID-19 Impact. Gilead also won an award in this category. LEARN MORE: iSpeak
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