Reactor Blast Kills Two, Injures Two Others

A reactor blast in the upper floors of Jeevika Life Sciences in Hyderabad, India has killed two and injured two others. According to published reports, about 20 persons were working near the reactor when it exploded. The blast blew the roof of the building to pieces with locals reporting hearing the blast as far as a mile away. The resulting fire took roughly four hours to bring under control. However, before the police and fire department personnel could reach the facility for rescue operations, two of the workers had already succumbed to their injuries. Authorities say restoration and rescue operations will remain underway throughout the week. Learn More

Novartis Ending Drug Discovery at Shanghai R&D Hub, Will Focus on Early Development

Looking to capitalize on China's growing biopharmaceutical ecosystem, Novartis has decided to end drug discovery at its Shanghai R&D hub and shift resources toward early development and commercial activities. First reported by FierceBiotech, the restructuring will eliminate about 150 early discovery jobs in the near-term but add 340 development and commercial roles by 2023. According to Fierce, Novartis does not intend to stop drug discovery at any of its other research sites, which span from California to Massachusetts to Basel, Switzerland. Learn More

Supreme Court Rejects ‘Pharma Bro’ Martin Shkreli’s Final Appeal

"Pharma Bro" Martin Shkreli has lost his legal bid to have the U.S. Supreme Court review his 2017 federal convictions on securities fraud charges. The high court included Shkreli's petition with a group of potential appeals that it denied without comment this week. The decision ends the appeal process for the businessman notorious for driving a 5000% price hike on a drug used to treat an illness that attacks those with the HIV virus and others with weakened immune systems. Shkreli, 36, is currently serving a seven-year sentence at the low-security federal correction center in Allenwood, Pennsylvania. He is scheduled to be released in September 2023, a federal inmate registry shows. Learn More

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EC Considers Amending Provision on Duplicate MAAs for Biologics

Earlier this month, the European Commission's (EC) Pharmaceutical Committee met to discuss how the use of duplicate marketing authorization applications (MAAs) - including the use of duplicate reference biologics, dubbed "autobiologicals" - can impact the availability and pricing of biological products and biosimilars. According to the EC, requests for duplicate MAAs have increased steadily, and this is a trend that is likely to continue. As such, some are calling for stricter scrutiny of autobiologicals especially as they can be considered generics and therefore cut biosimilars out of certain markets where pharmacy substitution for biosimilars is not allowed. Learn More

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Raman Spectroscopy as a Method to Replace Off-Line pH During Mammalian Cell Culture Processes

Raman spectroscopy is a robust, well-established tool utilized for measuring important cell culture process variables for example, feed, metabolites, and biomass in real-time. This study further expands the functionality of in-line Raman spectroscopy coupled with partial least squares (PLS) regression modelling to develop a pH measurement tool. Cell line specific models were developed to enhance the robustness for processes with different pH setpoints, deadbands, and cellular metabolism. The modelling strategy further improved robustness by reducing the temporal complexity of pH shifts by splitting data sets into two time zones reflective of major changes in pH... Learn More

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I need a bioprocess analyzer that is well suited for microbial fermentation, any suggestions?

In years past I would have two manufacturers of bioprocess analyzers to suggest to you, but to quote a memorable line from a forgettable movie, today "there can be only one." I would suggest taking a look at the Roche Cedex Analyzer solutions. Based on several publications I have read their suite of metabolites and substrates have proven well suited for microbial fermentation.

Roche Cedex Analyzers

A Novel Approach to Real-Time Monitoring of Antibody Titer in a Fed-Batch Bioreactor Run

The titer of an antibody being expressed in a stirred bioreactor is usually measured offline using a process that involves removing an aliquot aseptically from the bioreactor, centrifuging the aliquot, and analyzing the resulting supernatant. The supernatant is analyzed either by bio-layer interferometry (BLI), Protein A HPLC, or ELISA. Such an approach may limit throughput, workflow, and efficiency. Aragen evaluated a prototype chromatography-based device that is directly connected to a bioreactor. Learn More

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Webinar: Role of Data Analytics in Single-Use Bioprocessing

Wednesday, November 20th, 2019

Data Analytics is one of the key trends within the pharmaceutical industry, both for the production of 'classical' drugs as well as large molecules. Companies are looking for ways to shift from the traditional way of operations to a more smart and optimal approach. The main advantages associated with such processes are more room for modularity, automation, and flexibility due to a smaller footprint, but also a more consistent quality of the drug product. The regulatory bodies see the promise of these processes and actively promote companies to implement this manufacturing strategy. This is illustrated by the recently published draft guidelines from the FDA for the production of small molecule drugs using continuous processes and the active discussion with the (bio)pharmaceutical industry through their Emerging Technology Program.

The amount of data and information generated in continuous and batch processing creates new opportunities to expand the use of multivariate process modeling. This webinar will cover and expand upon the MVDA and DOE offerings of Sartorius as a part of the Umetrics Suite while covering different modes of implementation, advantages and talk about why data analytics is now a cardinal need of the industry.

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UCSF Team Blocks Enzyme That Contributes to the Spread of Breast Cancer

In a breakthrough with important implications for the future of immunotherapy for breast cancer, UC San Francisco scientists have found that blocking the activity of a single enzyme can prevent a common type of breast cancer from spreading to distant organs. While studying a mouse model that replicates key features of early-stage human breast cancer, the researchers discovered that a ubiquitous enzyme called MMP9 is an essential component of the cancer's metastasis-promoting machinery, helping to create a hospitable environment for itinerant cancer cells to form new metastatic tumors. The new study is published this week in the journal Life Science Alliance. Learn More

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Epigenetic Analysis of Cell Therapy and Related Methods

A U.S. Patent Application for "Epigenetic Analysis of Cell Therapy and Related Methods" was awarded to Juno Therapeutics on November 14th, 2019. The present invention is a method of identifying one or more genomic region(s) associated with an outcome of treatment with a cell therapy, the method comprising: (a) analyzing or determining an epigenetic property of one or more genomic regions of a cell or a population of cells, said cell or population comprised in (i) a first composition of cells to be genetically engineered with a recombinant receptor to produce a second composition comprising the recombinant receptor, or (ii) a second composition of cells. Learn More

1975 “One Flew Over the Cuckoo’s Nest” Opens in Theaters

On this day in 1975, One Flew Over the Cuckoo's Nest, a film about a group of patients at a mental institution, opens in theaters. Directed by Milos Forman and based on a 1962 novel of the same name by Ken Kesey, the film starred Jack Nicholson and was co-produced by the actor Michael Douglas. One Flew Over the Cuckoo's Nest went on to become the first film in four decades to win in all five of the major Academy Award categories: Best Actor (Nicholson), Best Actress (Louise Fletcher, who played Nurse Ratched), Best Director, Best Screenplay (Adapted) and Best Picture. Learn More

Looking back at the last decade, which of the following comes closest to your view?

I've accomplished more than I expected to
I've accomplished less than I expected to

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Why You Should Treat the Tech You Use at Work Like a Colleague

Imagine your company hires a new employee and then everyone just ignores them, day in and day out, while they sit alone at their desk getting paid to do nothing. This situation actually happens all the time -- when companies invest millions of dollars in new tech tools only to have frustrated employees disregard them, says Nadjia Yousif. In this fun and practical talk, she offers advice on how to better collaborate with the technologies in your workplace -- by treating them like colleagues. Learn More

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Fujifilm Diosynth Investing $55M to Build Gene Therapy Innovation Center in Texas

Fujifilm Diosynth Biotechnologies has announced the expansion of its gene therapy services with the addition of dedicated process and analytical development laboratories. As part of a capital investment of approximately $120 million in the gene therapy field by FUJIFILM Corporation, an investment of approximately $55 million USD will be made to establish a new Gene Therapy Innovation Center adjacent to the existing state-of-the-art cGMP gene therapy manufacturing facility in College Station, Texas. The Gene Therapy Innovation Center will be approximately 60,000 square feet and house state-of-the-art upstream, downstream and analytical development technologies. The facility will be operational in the fall of 2021. Learn More

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The Four Construction Bay Doors on NASA’s Vehicle Assembly Building are the World’s Largest Doors

At 456 feet high, they are taller than the Statue of Liberty. Learn More