News Alert

5 Killed in Blaze at Serum Institute of India’s Pune Site

At least five people were killed in a fire that broke out at a building under construction at Serum Institute of India’s site in Pune. According to published reports the victims of the fire, the cause of which has yet to be determined, were most likely construction workers. The company said the fire was restricted to a new facility it is constructing to increase the production of COVID-19 vaccines and ensure it is better prepared for future pandemics. Serum Institute of India is the world’s largest maker of vaccines and has been contracted to manufacture a billion doses of the AstraZeneca/Oxford University vaccine.
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Northway Biotech Opens New $40 Million Biopharmaceutical Manufacturing Facility in Waltham

Northway Biotech has opened its new 30,000-square-foot process development and cGMP manufacturing site in Waltham, Massachusetts. From cell line development to cGMP DS manufacturing and aseptic filling, the state-of-the-art facility, in the booming biotech hub in the Greater Boston area, will provide end-to-end services for biologics microbial and mammalian-based biologics. The cGMP biomanufacturing suite will house 500 L microbial and 2,000 L mammalian bioreactors and be operational in Q4 2021, representing a capital investment program worth $40 million.
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Sartorius Stedim Biotech’s $1.5M Gift Creates Cell Culture Facility

Sartorius Stedim Biotech has committed $1.5 million to Penn State to create the Sartorius Cell Culture Facility, which will expand Penn State’s biotechnology ecosystem. Sartorius’ gift expands their partnership with Penn State to advance multidisciplinary teaching and research in biotechnology through hands-on experiences for undergraduate and graduate students and corporate employees and providing exposure to research innovations across numerous fields. The Sartorius Cell Culture Facility, part of the Huck Institutes of the Life Sciences, will be the third leg in the biotechnology ecosystem that includes the Center of Excellence in Industrial Biotechnology and the CSL Behring Fermentation Facility.
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Regulatory Alert

Amid Pandemic, EMA’s 2020 Authorizations Ticked Upward

Despite the pandemic, the European Medicines Agency (EMA) issued many more positive recommendations for human medicines in 2020 than in the previous year, according to a new report from the agency highlighting the year’s regulatory activities. In 2020, 97 new medicines were recommended for authorization by EMA; of these, 39 contain a new active substance (NAS). In 2019, EMA issued 66 positive opinions for medicines, 30 of which contained a NAS. The total numbers of new recommendations include conditional marketing authorizations such as the ones issued for the COVID-19 treatment Veklury (remdesivir) and Comirnaty, the COVID-19 vaccine co-developed by Pfizer and BioNTech.
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Resource Alert

Fractional Lotka-Volterra Model with Time-Delay and Delayed Controller for a Bioreactor

In this paper, a fractional Lotka-Volterra mathematical model for a bioreactor is proposed and used to fit the data provided by a bioprocess known as continuous fermentation of Zymomonas mobilis. The model contemplates a time-delay τ due to the dead-time in obtaining the measurement of biomass x(t). A Hopf bifurcation analysis is performed to characterize the inherent self oscillatory experimental bioprocess response. As consequence, stability conditions for the equilibrium point together with conditions for limit cycles using the delay τ as bifurcation parameter are obtained. Under the assumptions that the use of observers, estimators or extra laboratory measurements are avoided to prevent the rise of computational or monetary costs, for the purpose of control, we will only consider the measurement of the biomass. 
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Solution Alert

The Use of a Microbioreactor as a High-Throughput Screening Tool for Immunotherapy Applications

Adoptive T-cell Therapy is a promising area of medicine where the lymphocytes are used to induce antitumor effects in patients with haematological malignancies. Despite the recent commercial approval of chimeric antigen receptor (CAR) T-cells to treat B-cell acute lymphoblastic leukaemia and non-Hodgkin lymphoma, the design space for the manufacturing of T-cell therapies is yet to be fully characterised and optimised. High throughput systems such as micro-Matrix (Applikon Biotechnology) in combination with Design of Experiment approach is a powerful tool for screening culture conditions for manufacture of T-cells at the micro-scale.
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Bioprocess Alert

Sensitivity of a PER.C6 Cell Line to Bis(2,4-di-tert-butylphenyl) Phosphate and Evaluation of a New, Biocompatible Single-Use Film

Single‐use technologies have brought numerous advantages to the biopharmaceutical industry. In particular, single‐use bags made from multi‐layered polymeric films have been adopted for cell culture and liquid handling operations in place of traditional stainless‐steel systems. This publication investigates inconsistent cell growth observed in a PER.C6® cell line during bioprocess development. The growth inhibition was linked to leachable migration from Bioclear™ 10, a single‐use film from Cytiva (formerly GE Healthcare) that was used for cell expansion. It was shown that the PER.C6® cells displayed a sensitivity to bDtBPP, comparable to that observed in sensitive CHO cell lines. Finally, biocompatibility of PER.C6® with Cytiva's new Fortem film was evaluated, demonstrating that Fortem™ film is a suitable single‐use technology for culturing PER.C6® cells.
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Market Alert

Event Alert

Launch of ICON™ and STUDIUS™ – New Products for an Integrated Cell Line Development Workflow

Monday, January 25th, 2021

Duncan Borthwick, PhD, Global Marketing Manager Solentim Ltd.,
Mark Stockdale, Amalgamator of Business and Biology, Galvanize Bio

This informative webinar, market leader Solentim will introduce two new products, an instrument named ICON™, that is designed to empower laboratories to make better decisions faster, and an over-arching software platform called STUDIUS™. Attendees will learn about how these two new products work to provide a new data-driven workflow for the development of modern cell-based therapies. Participants will be hearing from Solentim’s R&D and biology groups alongside cell line development experts in this first insight into Solentim’s new products. Register for this webinar to view the presentation, with the opportunity to ask the development team about the capabilities of these new systems.
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Discovery Alert

Immune System Mounts a Lasting Defense After Recovery from COVID-19, Researchers Find

As the number of people who have fought off SARS-CoV-2 climbs ever higher, a critical question has grown in importance: How long will their immunity to the novel coronavirus last? A new Rockefeller study offers an encouraging answer, suggesting that those who recover from COVID-19 are protected against the virus for at least six months, and likely much longer. The findings, published in Nature, provide the strongest evidence yet that the immune system "remembers" the virus and, remarkably, continues to improve the quality of antibodies even after the infection has waned. Antibodies produced months after the infection showed increased ability to block SARS-CoV-2, as well as its mutated versions such as the South African variant.
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Patent Alert

Purification of Biological Molecules

A U.S. Patent for "Purification of Biological Molecules" was awarded to MilliporeSigma on December 15th, 2020. The present invention is a continuous process for the purification of a target molecule comprising the steps of: a) providing a sample comprising the target molecule and one or more impurities; b) adding at least one precipitant to the sample and removing one or more impurities, thereby to recover a clarified sample; c) subjecting the clarified sample from step (b) to a bind and elute chromatography step comprising at least two separation units, thereby to obtain an eluate comprising the target molecule; and d) subjecting the eluate to flow-through purification comprising use of two or more media, one of which is activated carbon and the other(s) are selected from anion-exchange chromatography media...
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Quote Alert

On This Day Alert

1984 – Apple introduces Macs with “1984” Superbowl Ad

During the CBS broadcast of Super Bowl XVIII, Apple premiered its “1984” commercial to a mass audience introducing Macintosh computers. The commercial is considered to be a masterpiece in advertising. Most interpret the commercial’s unnamed heroine as representing the coming of the Macintosh and a computing revolution. She wears a white tank top with a drawing of a Macintosh as she runs from guards to save humanity from conformity and Big Brother.
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Poll Alert

If you have a choice, when on a conference call with colleagues, do you use the video function?

Yes
No

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TED Alert

How Amazon, Apple, Facebook and Google Manipulate Our Emotions

The combined market capitalization of Amazon, Apple, Facebook and Google is now equivalent to the GDP of India. How did these four companies come to infiltrate our lives so completely? In a spectacular rant, Scott Galloway shares insights and eye-opening stats about their dominance and motivation -- and what happens when a society prizes shareholder value over everything else. Followed by a Q&A with TED Curator Chris Anderson. (Note: This talk contains graphic language.)
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Project Alert

Northway Biotech Opens New Biopharmaceutical Manufacturing Facility in Waltham

Northway Biotech has opened its new 30,000-square-foot process development and cGMP manufacturing site in Waltham, Massachusetts. From cell line development to cGMP DS manufacturing and aseptic filling, the state-of-the-art facility, in the booming biotech hub in the Greater Boston area, will provide end-to-end services for biologics microbial and mammalian-based biologics. The cGMP biomanufacturing suite will house 500 L microbial and 2,000 L mammalian bioreactors and be operational in Q4 2021, representing a capital investment program worth $40 million.
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Fact Alert

The director of the ‘1984’ Apple commercial, which introduced Mac computers during Super Bowl XVIII, was English film director and producer Ridley Scott.

Ridley Scott is best known for directing the science fiction horror film Alien, the neo-noir dystopian film Blade Runner, the road adventure film Thelma & Louise, the historical drama film Gladiator, the war film Black Hawk Down, and the science fiction film The Martian (2015). Beginning his career in advertising, where he honed his filmmaking skills by making inventive mini-films for television commercials, Scott's work is known for its atmospheric and highly concentrated visual style.
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