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.
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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.
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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.
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.
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.
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.
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.
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.
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.
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