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10/15/2021

Officials from the Sacramento-Yolo Mosquito and Vector Control District in California reported that they had trapped a female Aedes aegypti mosquito, a species capable of transmitting the viruses such as those that cause dengue fever and Zika fever. "We will continue to work diligently looking for and identifying locations where these mosquitoes could be breeding," district manager Gary Goodman said.

10/15/2021

Loop Medical, a Swiss company that makes blood collection devices, brought in $6.4 million from investors in a Series A funding round. The company will use the proceeds to seek FDA clearance for a product being developed for use in the home, in clinical trials and for liquid biopsies.

10/15/2021

Leftover specimens can hold value for researchers, allowing them to better understand the causes of diseases and conduct biomarker evaluation. However, researchers must consider
compliance, quality, data availability on the subject, specimen appropriateness, storage conditions and handling, and they should take care with specimen descriptions and interpretation of findings.

10/14/2021

An NIH study that included over 450 adults who had been vaccinated against COVID-19 found that people who were given Johnson & Johnson's vaccine had a more durable immune response when they received a booster shot from either Moderna or Pfizer/BioNTech. The preliminary results still need to undergo peer review but could factor into a decision on J&J's request for authorization of the company's own COVID-19 vaccine as a booster.

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Reuters
10/14/2021

The World Health Organization said that an Ebola vaccination campaign is underway in eastern Democratic Republic of Congo following the death of a young boy to the illness. More than 170 people are being monitored, and 200 vaccine doses are on their way to the city of Beni.

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Reuters
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World Health Organisation
10/14/2021

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.

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Regulatory Focus
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National Formulary
10/14/2021

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.

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BioPharmaReporter
10/14/2021

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.

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Bioprocess Online
10/14/2021

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.

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Unilife
10/14/2021

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.