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Aspen Alert

Issue # 3582 | November 16th, 2021      

   News Alert

Biogen’s Head of R&D, Alfred W. Sandrock, Jr., to Retire

Biogen has announced that Alfred “Al” W. Sandrock, Jr., M.D., Ph.D., Head of Research & Development, will retire from the Company effective December 31, 2021. A 23-year veteran of Biogen, Dr. Sandrock, 64, led the development of many of the Company’s most important and transformational therapies in neurological diseases, including Tysabri®, Tecfidera®, Spinraza®, Plegridy® and Aduhelm™. Dr. Sandrock served on Biogen’s Executive Committee since 2015, as Head of Research & Development since October 2019, and as Chief Medical Officer from 2012 to 2020. Priya Singhal, M.D., M.P.H., Head of Global Safety and Regulatory Sciences, will assume Dr. Sandrock’s duties as Head of R&D on an interim basis until a permanent successor is identified.
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After Triggering a Global Valsartan Recall 3 Years Ago, Chinese Drug Manufacturer Overcomes FDA Warning Letter

The Chinese pharma manufacturer that was the first domino to fall in the high-profile scrutiny over possible cancer-causing impurities in heart drugs has overcome an FDA warning letter three years after the regulatory sanction. The FDA has now closed a warning letter that was slapped on Zhejiang Huahai Pharmaceutical’s Chuannan site in Taizhou, the agency recently disclosed. The closeout of the warning letter marks a key step in Huahai’s return to the U.S. market and the nearing of the end of a three-year saga battling serious reputation damages not just to the company itself but the overall quality of drug production in China as well. Though the warning letter is off Huahai’s back, the company can’t yet start selling its products in the U.S. thanks to an import ban that affects 29 products, according to the company.
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UK Firm to Trial T-Cell Covid Vaccine that Could Give Longer Immunity

A UK company will soon start clinical trials of a second-generation vaccine against Covid-19, an easy-to-administer skin patch that uses T-cells to kill infected cells and could offer longer-lasting immunity than current vaccines. Emergex was set up in Abingdon in 2016 to develop T-cell vaccines, the brainchild of Prof Thomas Rademacher, the firm’s chief executive and professor emeritus of molecular medicine at the University College London medical school. The vaccines prime T-cells to remove infected cells from the body quickly after infection, thus preventing viral replication and disease. While the antibodies produced by the current Covid vaccines stick to the virus and stop it infecting cells, T-cells find and destroy infected cells.
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   Quote Alert

   On This Day Alert

1990 – Home Alone Is Released In Theaters

The 1990 American comedy classic film, Home Alone, directed by Chris Columbus and written by John Hughes was released in theaters on this day in 1990. It received positive reviews, with praise for its cast, humor, and music. The movie grossed $476.7 million worldwide, becoming the highest-grossing live-action comedy until the release of The Hangover Part II, and made Culkin a child star. It was nominated for the Golden Globe Award for Best Motion Picture – Musical or Comedy, and Best Actor in a Motion Picture – Musical or Comedy for Culkin, and for the Academy Award for Best Original Score for John Williams, and Best Original Song for "Somewhere in My Memory". Home Alone has since been considered one of the best Christmas films.
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  TED Alert

Being An Abandoned Child

Brendan Maguire’s community became his home when he moved from house to house after his parents left him with his three brothers and a sister when he was 4 at a shopping mall.
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  Poll Alert

Is the world's climate changing as a result of human activity?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

Continuous, Precisely Regulated Nutrient Supply in a Bioreactor

A bioreactor’s purpose is to provide the greatest possible product yield. To do this, it requires precise regulation of all important parameters like nutrient concentration, temperature, or oxygen content to optimally support fermentation. Learn how you can use customized valve and sensor solutions for secure, reproducible processes in your fermenters.
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Survey Alert

Do you agree with the statement “currently and for the next generation of antibodies, global biomanufacturing is a major bottleneck”?  Please comment on your reason(s).

► Strongly Agree
► Agree
► Disagree
► Strongly Disagree

Previous Survey Results:

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  Upstream Alert

Analysis of Methods for Quantifying Yeast Cell Concentration in Complex Lignocellulosic Fermentation Processes

Cell mass and viability are tightly linked to the productivity of fermentation processes. In 2nd generation lignocellulose-based media quantitative measurement of cell concentration is challenging because of particles, auto-fluorescence, and intrinsic color and turbidity of the media. We systematically evaluated several methods for quantifying total and viable yeast cell concentrations to validate their use in lignocellulosic media. Several automated cell counting systems and stain-based viability tests had very limited applicability in such samples. In contrast, manual cell enumeration in a hemocytometer, plating and enumeration of colony forming units, qPCR, and in situ dielectric spectroscopy were further investigated.
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Event Alert

The Search for Funding: What you Should Prepare Prior to your Pitch

Wednesday, November 17, 2021

Lee Johnson, Patents and Innovations Partner at Wilson Sonsini

In the hunt for financing, once you have done your research and secured VC introductions that lead to meetings, it’s time to prepare for the diligence and pitching stages. It’s vital that company founders prepare a pitch to meet VC expectations and create a compelling intellectual property and patent portfolio that will hold up to VC scrutiny and funding agreements. The steps required to prepare for VC meetings and partnerships can be daunting, so significant planning and preparation is key.
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 Downstream Alert

Continuous Chromatography of Peptides

Throughout the production of APIs (active pharmaceutical ingredients), meeting high yield and high purity during the purification step still represents a tremendous challenge. On the other hand, demands for large batch sizes of peptide APIs are steadily increasing. In particular, if impurities cannot be separated efficiently from the API product, innovations in new, more efficient purification methods are required. These innovations are needed to keep the costs of goods low and contribute to a reduced environmental footprint of the purification process. Therefore, Bachem implemented an innovative process for large-scale GMP purification, MCSGP, Multicolumn Countercurrent Solvent Gradient Purification. Our new technology provides attractive economic benefits by increasing capacity, with lower solvent consumption.
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  Podcast Alert

Killer Asteroids: NASA Strikes Back

Asteroids! In just two weeks, NASA plans to launch a first-of-its-kind mission to try to move an asteroid off its path. If it works, this could be a huge breakthrough in protecting us from runaway space rocks. So we’ve updated this episode from a few years ago, where we talked about how serious this asteroid threat is — and some of the other ways we might fight back. We speak with asteroid researcher Dr. Alan Harris, astrophysicist Dr. Sergey Zamozdra, computational physicist Dr. Cathy Plesko, and physicist Dr. Andy Cheng.
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  Fill/Finish Alert

Fatty Acids Can Induce the Formation of Proteinaceous Particles in Monoclonal Antibody Formulations

The presence of subvisible or visible particles in mAb formulations can pose significant challenges to pharmaceutical development as it can lead to reduced shelf life, batch rejection, and recalls. Among all type of particles, proteinaceous particles are the most concerning due to their potential role in immunogenicity. Nevertheless, the underlying mechanism for protein particle formation remains poorly understood. Past research highlighted the importance of interfaces and mechanical agitation in causing protein particle formation. Current research suggests that fatty acids, as impurities present in excipients or as a result of polysorbate degradation, can also induce protein assembly and promote particle formation.
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  Regulatory Alert

FDA Officials Address Common Pitfalls Affecting Post-Approval Change Applications

The US FDA has offered some advice to help ensure smoother reviews of abbreviated new drug application (ANDA) post-approval supplements and addressed how certain changes should be categorized at the November 10 meeting of the Association for Accessible Medicines” (AAM) GRx+Biosim conference. Officials were asked to address common issues affecting ANDA post-approval chemistry, manufacturing, and controls (CMC) submissions. Agency officials discussed some of the documents that should accompany ANDA post-approval submissions, such as cover letters and the Form FDA 356h, and addressed whether nitrosamine risk assessment reports should be included in supplement requests.
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  Discovery Alert

Best Way to Avoid Procrastination

They say procrastination is the thief of time -- actually deadlines are. New research from the University of Otago has found that if you want someone to help you out with something, it is best not to set a deadline at all. But if you do set a deadline, make it short. Professor Stephen Knowles, from the Otago Business School, Department of Economics, and his co-authors tested the effect of deadline length on task completion for their research published in Economic Inquiry.
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  Project Alert

A California Biotech Steps Into the Viral Vector Space with New Site Build of $75M

As cell and gene therapy gets hotter, a California CDMO has made a play to open an entirely new arm of its operations to fill a void in the market. Avid Bioservices will move into the cell and gene therapy market, with the construction of a 53,000 square-foot viral vector cGMP manufacturing site down the road from its Tustin, CA headquarters. The site will be completed within 18 months, with CEO Nicholas Green saying that January 2023 is an anticipated opening date. If the project stays on track, its analytical and process development labs could be ready for partial use in the next six to eight months.
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  Patent Alert

Method and Apparatus for an Integrity Test of a Flexible Container with Inspection Fluid

A U.S. Patent for "Method and Apparatus for an Integrity Test of a Flexible Container with Inspection Fluid" was awarded to Sartorius on August 31, 2021. The present invention is a method, a device and a use of the device are provided for carrying out an integrity test on a test container (1) that has at least one flexible casing material. The method includes the steps of: filling a test fluid into the test container (1); and detecting the presence of test fluid directly outside the test container (1). The test fluid is designed in such a way that the permeation rate of test fluid through undamaged casing material of the test container (1) is not greater than 110.sup.-6 mbarm/(sbar).
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  Solution Alert

On a Deadline: Time to Take Design & Build to the Next Level

The benefits of the Design/Build (DB) approach and its advantages over the conventional Design/Bid/Build (DBB) approach have been well known for decades when it comes to realizing new facilities for cGMP manufacturing in the biopharma industry. With the increasing industry demand for compressed schedules, reduced total costs, and improved quality of construction, it is somewhat surprising that the traditional DBB methodology is still favored by manufacturers (owners) building new facilities. The COVID-19 pandemic and need for new manufacturing capability for vaccines and therapeutics has not only reinforced the need for the DB methodology but has in fact shown that more innovative Pre-Design/Prefabricate (PDPF) approaches to new facility construction can be impactful.
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  Humor Alert

  Fact Alert

Joe Pesci Got All Method On Macaulay Culkin In Home Alone

In order to get the most authentic performance possible, Joe Pesci did his best to avoid Macaulay Culkin on the set so that the young actor would indeed be afraid of him. And no one would blame the young actor for being a bit petrified, as he still bears the physical scar from one accidental altercation. “In the first Home Alone, they hung me up on a coat hook, and Pesci says, ‘I’m gonna bite all your fingers off, one at a time,’” Culkin recalled to Rule Forty Two. “And during one of the rehearsals, he bit me, and it broke the skin.”
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   Career Alert

Flownamics
Technical Sales Representatives
Various, United States
The ideal candidate will have a bachelor’s degree or relevant experience in biopharma. Responsibilities include travel throughout the assigned territory calling on both existing and prospective customers to promote Flownamics products and services, documenting sales activities and the like. Learn More

Sartorius
Product Specialist, Chromatography Hardware - Remote
Field Application Specialist, Bioprocessing – Chromatography - Remote
Field Application Specialist, Bioprocessing – Chromatography - Remote
New Customer Sales Specialist - Marlborough, MA
Customer Development Specialist - Marlborough, MA
Customer Development Specialist - Fremont, CA
Customer Development Specialist - Remote
Order Process Management Specialist - Bohemia, NY
Order Process Management Specialist - Marlborough, MA
Order Process Management Specialist II - Bohemia, NY
Order Process Management Specialist III - Bohemia, NY

Saint-Gobain
Applications Engineer II
Beaverton, MI
In this position, the employee will work with customers in developing innovative Single-Use solutions for Bio/pharmaceutical & Medical applications using Saint-Gobain and other supplied components. Learn More

Sanofi
Principal Engineer, Upstream
Framingham, MA
The successful candidate will work with a group of scientists and engineers responsible for technology transfer mammalian cell culture processes to a diverse network of manufacturing facilities, Lifecycle Management and support of commercial processes. Learn More

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