January 14, 2021
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Pfizer raised its COVID-19 vaccine production goal to 2 billion doses this year as new US government recommendations add 128 million people to the eligibility list. Pfizer has committed to making 600 million doses for the EU and 200 million for the US. New vials will be labeled for six doses instead of five, and a more accurate syringe will accompany the vials.
Full Story: MLive (Michigan) (tiered subscription model) (1/12),  Bloomberg (1/13) 
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Summit: How a Crisis Enabled Clinical Innovation
Life science companies have been forced to pivot to a digital-first environment and under intense pressure deliver diagnostics, vaccines and therapeutic solutions at unprecedented speed. Join our panel of experts on January 28, 2021 at 2PM ET to discuss how the regulatory environment was affected by the pandemic and predictions for the future of R&D. Register now.
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Process development and manufacturing
Pharmaceutical development and manufacturing have been intently focused on COVID-19 for the past year, but the sector appears to be returning to normal, as the late-stage drug pipeline is 17% larger and the early-stage pipeline is 25% larger than a year ago, according to investment firm William Blair. Executives at Cambrex, Catalent, Lonza and Siegfried say they expect strong demand this year.
Full Story: Chemical & Engineering News (tiered subscription model) (1/10) 
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Facilities and equipment
Former Centrient Pharmaceuticals CEO Karl Rotthier will lead EuroAPI, Sanofi's active pharmaceutical ingredients business unit based in France with sites in Germany, Hungary, Italy and the UK.
Full Story: Reuters (1/12),  FiercePharma (1/13) 
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Chemical manufacturer Henkel and unnamed US manufacturers are among industrial companies using wrist-worn devices from Kinexon that help track worker movements and ensure social distancing. The wristbands emit ultra-broadband signals and issue a warning when wearers are within 6 feet of each other for more than five seconds.
Full Story: The New York Times (1/12) 
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Information systems
Artificial intelligence can improve decisions about how data from biomanufacturing processes are analyzed, but the analytical method must be appropriate for the data, and using only familiar methods can produce suboptimal results, says Fabian Mohr, an advanced manufacturing systems researcher at MIT. A machine learning approach developed by Mohr and his colleagues selects a subgroup of algorithms based on specific characteristics in early data and cross-validates to select the best analytic method.
Full Story: Genetic Engineering & Biotechnology News (1/12) 
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A new partnership between Boehringer Ingelheim and Google Quantum AI will apply quantum computing to pharmaceutical research and development. Quantum computing can simulate and compare molecules that are larger than other computing methods can handle, and it could accelerate and enhance drug discovery, according to the pharma company.
Full Story: PharmaTimes online (UK) (1/11) 
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Supply chain management
Vaccine vials are made of durable, temperature-resistant borosilicate glass, most of which the world sources from outside the US, and medical glass manufacturer Schott AG says it has already received requests for twice as many vials as it can produce in a year, writes MxD CEO Chandra Brown. In the US, the government could invoke the Defense Production Act to compel manufacturers to produce vials, commit to purchasing vials and offer direct loans or loan guarantees for scaling up production, Brown writes.
Full Story: Government Executive (1/12) 
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Standard five-dose vials of Pfizer/BioNTech's COVID-19 vaccine contain enough for six or seven doses, but hospital pharmacists say some syringes in vaccination kits from the federal Operation Warp Speed initiative are not efficient enough to extract the extra doses, leaving hospitals to waste unused product.
Full Story: Politico (1/10) 
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Quality and regulatory issues
The UK Medicines and Healthcare products Regulatory Agency's spreadsheet of good manufacturing practice inspection data for 2019 ran more than 5,300 lines, and Unger Consulting analyzed the data in a two-part set of articles. Quality Systems, Chapter 1 is the most frequently cited inspection deficiency; and Computerised Systems, Annex 11 is in the top 10 for both critical and major deficiencies, writes Barbara Unger, co-lead of the Rx-360 Data Integrity Working Group.
Full Story: BioProcess International online (1/11) 
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Research and development
An adenovirus-based COVID-19 vaccine being tested and produced by Johnson & Johnson requires only one dose and is refrigerator-stable for months, giving it an advantage over two-dose mRNA-based vaccines if it is approved. J&J signed an agreement to provide 12 million doses to the US government by the end of February and 100 million doses by the end of June, but the company is reportedly up to two months behind the original production schedule, and clinical trial results are not expected until late this month or sometime next month.
Full Story: The New York Times (1/13) 
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ISPE update
Hear from Tom Hartman, ISPE President & CEO, as he highlights the can't-miss discussions that will take place during the 2021 ISPE Aseptic Conference. Watch Now: ISPE
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Featured in this edition of iSpeak Reading Roundup are the top blog posts from December 2020. Discover key insights on FDA lessons learned from COVID-19, current challenges in implementing quality risk management and more. Full Story: iSpeak
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