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U.S. FDA Gearing Up for Rapid Review of Potential COVID-19 Booster Shots

The U.S. FDA is planning a rapid review process for quick turnaround of new COVID-19 booster shots if variants of the coronavirus emerge against which the vaccines do not provide protection, the agency’s top official says. Dr. Janet Woodcock, acting commissioner of the FDA, said that if new variants of the coronavirus emerge that require booster shots or changes to vaccines, the agency will not require the type of large trials that were required for emergency use authorization or approval. The agency plans to issue a proposal on the process for public comment in a few weeks, she said during a press briefing.
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Sanofi Flunks Phase 2 Parkinson’s Test, Culls Clutch of Programs

A phase 2 clinical trial of venglustat in Parkinson’s disease patients has failed, prompting Sanofi to stop work in the indication. Sanofi disclosed the setback alongside news that it is stopping work on a clutch of other midphase programs. The setback still leaves Sanofi with chances to get venglustat to market. Sanofi is enrolling, or set to start enrolling, patients in several phase 2/3 clinical trials. Those studies are targeting autosomal dominant polycystic kidney disease, late-onset GM2 gangliosidosis and Gaucher disease.
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Merck KGaA and BioNTech Extend Strategic Partnership Through Accelerated Supply of Urgently Needed Lipids

Merck KGaA and BioNTech are further expanding their strategic partnership. Merck KGaA, in close collaboration with BioNTech, will significantly accelerate the supply of urgently needed lipids and increase the amount of lipid delivery towards the end of 2021. The lipids will be used for the production of the Pfizer-BioNTech Covid-19 Vaccine (BNT162b2). Lipids are critical to the drug delivery system of mRNA therapies to the body for a vaccine to be effective. Only very few companies in the world are currently able to produce custom lipids in significant quantities and according to the highest quality requirements needed for vaccine production.
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FDA Plans Guidance to Address New COVID-19 Variants

The US FDA is actively monitoring and assessing how current vaccines, therapeutics, and diagnostics are impacted by emerging COVID-19 variants and will issue guidance for ongoing medical product development against these variants. In a recent statement, the FDA's acting commissioner Janet Woodcock, MD, said the agency has been monitoring potential new coronavirus variants since the start of the COVID-19 pandemic, and has been actively working with medical product sponsors and international partners to evaluate the impact new COVID-19 variants have on authorized medical products. The agency is continuing to take an “all-hands-on-deck” approach to the pandemic, she said. “As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic.”
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Implementation of Stir-Speed Adopted Controllers Onto a Batch Bioreactor for Improved Fermentation

Quality, quantity, and economy of the fermentation product depend on the transient response and the steady-state of the fermentation process. Due to its simple construction, an industrial batch bioreactor cannot be equipped with a closed-loop control system that applies adding or removing substances during fermentation. This theoretical and practical study displays how fermentation can be controlled, in this case by altering the rotational speed of a stirrer system of such a bioreactor. A numerical analysis was employed to set up a mathematical model that describes the impact of the stirrer speed on the fermentation. The model consists of linear and non-linear parts. To determine their parameters, a least square identification and a particle swarm optimization method were utilized. 
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Single-Use Diaphragm Valve

As the world’s first single use diaphragm valve, GEMÜ SUMONDO is a major step forward in Single-Use applications. The diaphragm valve body can be easily connected/disconnected from the actuator, it requires significantly less time to replace compared to normal cleaning and sterilization processes (CIP/SIP) in conventional plant. This reduces not only the investment costs, but also eliminates the time-consuming cleaning validation of the piping system/components which is no longer required.
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A Comparative Review of Multi-Rate Moving Horizon Estimation Schemes for Bioprocess Applications

Advanced control and monitoring of bioprocesses are dependent on accurate state and parameter information. At the same time, bioprocesses are well known for their time-varying behavior and difficulty of obtaining online measurements of the important process states. The selection and the tuning of the estimation algorithms is therefore crucial to the design of reliable monitoring tools. In this work we discuss the design of several Moving Horizon Estimation schemes for a class of bioprocesses. We compare the algorithms in terms of the arrival cost computation and address the implementation of a multi-rate measurement structure. The tuning of the estimators and further details are illustrated using a cell culture case study, where we show that not all the estimators under investigation can cope equally well with process uncertainty and multi-rate measurements.
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Webinar on RNA, Oligo Purification Technology

Wednesday, February 24th, 2021

Thomas Müller-Späth, Ph.D, CTO at YMC ChromaCon AG

For RNA and similar therapeutics, the application of twin-column HPLC systems enabled with the innovative MCSGP* approach is proving significant process time savings coupled with increase in yield. This webinar will present new data from purification studies using RNA drug precursors. The MCSGP technology will be briefly explained and then data from recent purification studies will be reviewed. In one case, the use of twin-column chromatography improved yield by +40%, allowing to produce 70% more product with the same feed material input, shorten production campaign time by 40%, or downsize upstream synthesis by 40%. *Multi-column Counter-current Solvent Gradient Purification
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Climate Change May Have Driven the Emergence of SARS-CoV-2

Global greenhouse gas emissions over the last century have made southern China a hotspot for bat-borne coronaviruses, by driving growth of forest habitat favoured by bats. A new study published in the journal Science of the Total Environment provides the first evidence of a mechanism by which climate change could have played a direct role in the emergence of SARS-CoV-2, the virus that caused the COVID-19 pandemic. The study has revealed large-scale changes in the type of vegetation in the southern Chinese Yunnan province, and adjacent regions in Myanmar and Laos, over the last century. Climatic changes including increases in temperature, sunlight, and atmospheric carbon dioxide have changed natural habitats from tropical shrubland to tropical savannah and deciduous woodland. This created a suitable environment for many bat species that predominantly live in forests.
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Chromatography Ligand Comprising Domain C from Staphylococcus Aureus Protein A for Antibody Isolation

A U.S. Patent for a "Chromatography Ligand Comprising Domain C from Staphylococcus Aureus Protein A for Antibody Isolation" was awarded to Cytiva on December 29th, 2020. The present invention relates to a chromatography ligand, which comprises Domain C from Staphylococcus protein A (SpA), or a functional fragment or variant thereof. The chromatography ligand presents an advantageous capability of withstanding harsh cleaning in place (CIP) conditions, and is capable of binding Fab fragments of antibodies. The ligand may be provided with a terminal coupling group, such as arginine or cysteine, to facilitate its coupling to an insoluble carrier such as beads or a membrane. The invention also relates to a process of using the ligand in isolation of antibodies, and to a purification protocol which may include washing steps and/or regeneration with alkali.
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1992 – The song “I’m Too Sexy” by Right Said Fred peaks at #1

One of the 1990’s most successful dance songs, “I’m Too Sexy”, the debut song by British group Right Said Fred, peaked to No.1 on the U.S Hot 100 on February 8, 1992, holding to the top position for three weeks
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Do you think women and men have fair and equal access to STEM (Science, Technology, Engineering, and Mathematics) jobs in America?

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Body Positivity or Body Obsession? Learning to See More and Be More

Objectification and body image are prevalent sources of poor mental health. Dr. Lindsay Kite, based on her own research and experiences, describes how body obsession can be turned into body positivity.
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Two Biotech Firms Investing Total of $228 Million to Build Facilities in Puerto Rico

CytoImmune Therapeutics and Biosimilar Sciences have made public plans to establish operations in Puerto Rico to develop their biotechnology products. For its part CytoImmune Therapeutics will invest $28 million for a facility to engage in developing cancer immunotherapy solutions. While Biosimilar Sciences will invest $200 million to establish a state-of-the-art biotech facility for the development of biosimilar products, including a COVID-19 vaccine, new cell and gene therapy, biologics, clinical studies, and other recombinant biotechnologies.
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The song “The Second Star to the Right” was originally written for Alice in Wonderland.

At the time, it was called “Beyond the Laughing Sky.” Here’s the Peter Pan version, then a brief explanation of the Alice song from Alice and Wendy herself, Kathryn Beaumont.
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