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Aspen Alert

Issue # 3585 | November 19th, 2021      

   News Alert

FDA Wants Until 2076 to Fully Release Pfizer Vaccine Data

The FDA has asked a federal judge to give it until the year 2076, roughly 55 years, to disclose all of the data and information it relied upon to license Pfizer’s COVID-19 vaccine. This request from the FDA comes after a group of more than 30 academics, professors, and scientists from some of the world’s leading universities filed a lawsuit seeking access to the data. The lawsuit comes after the FDA largely ignored the groups initial request that came in a Freedom of Information Act (FOIA) fling earlier this year. This latest response from the regulatory agency has raised concerns among many about its promise of transparency.
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Novo Nordisk Bets Big on RNAi, Paying $3.3B to Buy Dicerna

Lars Fruergaard Jørgensen has landed the major takeover he has targeted since taking over as CEO of Novo Nordisk. Having missed out on Ablynx to Sanofi in 2018, Novo Nordisk has agreed to a $3.3 billion buyout of its RNAi partner Dicerna Pharmaceuticals as part of its search for new growth drivers. Novo Nordisk has snagged its target with an offer that is an 80% premium over the closing price of Dicerna but still slightly down on the highs the biotech hit over the summer. The delivery of data on a rare kidney disease drug sank Dicerna’s stock in August, enabling Novo Nordisk to swoop in and buy the biotech at a price that would have been unthinkable just months ago.
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Novartis Rumored to be Looking at Alnylam After $21 Billion Windfall from Sale of Roche Stake

Almost four years after taking the reins, Novartis Chief Executive Officer Vas Narasimhan is under growing pressure to reshape the biopharma giant and make some shrewd moves. The urgency to act has only grown with the sale of a $21 billion stake in Roche this month that has given Novartis the financial firepower for a transformational deal. Buying a biotech company is one option, with Alnylam Pharmaceuticals a prime potential target, according to people with knowledge of the matter, who spoke on condition of anonymity because the discussions are private. This week Alnylam’s share price saw its biggest gain since the start of the year and Novo Nordisk agreeing to buy Dicerna, a company that uses similar technology to Alnylam’s.
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   Quote Alert

   On This Day Alert

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

“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.
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  TED Alert

The Mental Health System - A Call for Change

Nora shines a light on the realities of the mental healthcare system. She contrasts the medical treatment expectations for those in physical pain with those suffering from depression. Can we start to re-frame the perception of mental health needs, and their solutions? Nora’s experiences give us a positive affirmation.
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  Poll Alert

Do you have a clothing washer or dryer in your home?

► Both
► Washer Only
► Dryer Only
► Neither

Previous Poll Results:

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  Bioprocess Alert

Using Chemical Denaturants and Light Scattering to Determine Aggregation Propensity of Biopharmaceuticals 

Determining the developability of candidate molecules and optimizing formulations require rapid assessment of biophysical characteristics using accelerated stressors to represent normal storage conditions. Thermal stress is the most common approach in small molecules. Unfortunately, this relationship is not straightforward for biological molecules, so alternative approaches, such as using denaturants to accelerate non-native interactions, could prove beneficial. This webinar reviews light scattering-based methods for protein characterization and explains their utility, when combined with partially denaturing buffers, in understanding aggregation propensity of monoclonal antibodies (mAbs).
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Survey Alert

For the year ahead, what approach would you most recommend to suppliers of bioprocessing instruments, equipment, software, sensors and the like who debuted a new product either just before or during the challenges of the past 18+ months and are trying to gain industry awareness? Please comment on your reason(s).

► Exhibit at In-Person Conferences
► Increase Internet Presence / Virtual Resources
► Pursue On-Site Demos at Prospective Customers
► Other

Previous Survey Results:

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  Upstream Alert

Optimizing a Bioreactor Portfolio

This white paper examines the issues that many bioreactor manufacturers face when optimizing a bioreactor portfolio to meet the challenging scale-up requirements of their pharmaceutical clients. Specifically, there are often challenges associated with transferring technology from the laboratory scale to the production scale, as well as the reverse – downscaling cell culture and fermentation processes back to the R&D scale. A major factor impacting bioreactor system scalability is the availability of consistent in-line measurement technology for all reactor sizes.
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Event Alert

A Collaborate Path to Single-Use Supply Assurance 

Wednesday, December 8, 2021

Both end users and suppliers of single use solutions have been experiencing supply challenges over the past 2 years. This has only been exasperated by SARS-Cov-2 pandemic. This webinar looks at how leading biopharma companies such as Sanofi and a leading supplier of single-use solutions – Thermo Fisher Scientific – are addressing these challenges and developing collaborative processes. Designed as an interactive panel discussion, participants will get a better insight into how to think about their single-use supply chain of the future.
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 Downstream Alert

Single-Use Capture Purification of Adeno-Associated Viral Gene Transfer Vectors by Membrane-Based Steric Exclusion Chromatography 

We present membrane-based steric exclusion chromatography (SXC) as a universal capture step for purification of adeno-associated virus (AAV) gene transfer vectors independent of their serotype and surface characteristics. SXC is performed by mixing an unpurified cell culture supernatant containing AAV particles with polyethylene glycol (PEG) and feeding the mixture onto a chromatography filter unit. The purified AAV particles are recovered by flushing the unit with a solution lacking PEG. SXC is an inexpensive single-use method that permits to concentrate, purify, and re-buffer AAV particles with yields >95% and >80% impurity clearance. SXC could theoretically be employed at industrial scales with units of nearly 20 m2.
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  Podcast Alert

Leadership in Rare Diseases, Srini Ramanathan, SVP, R&D Sciences, Horizon Therapeutics

Srini Ramanathan, Ph.D., joined Horizon Therapeutics in 2018. He leads Horizon’s research and development sciences, with portfolio oversight of discovery, preclinical research and development functions; he also oversees scientific due diligence for business development evaluations. He has worked in the biotechnology industry over 20 years and has been involved in drug approvals across ophthalmology, oncology and virology. Before joining Horizon, Ramanathan served as senior project leader at AbbVie, overseeing the development of multiple immunology programs for rheumatology and gastrointestinal indications. Prior to AbbVie, he served as global head of clinical pharmacology at Gilead Sciences with responsibilities for portfolio programs across all therapeutic areas.
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  Fill/Finish Alert

Application of a High Throughput and Automated Workflow to Therapeutic Protein Formulation Development

Rapid and efficient formulation development is critical to successfully bringing therapeutic protein drug products into a competitive market under increasingly aggressive timelines. Conventional application of high throughput techniques for formulation development have been limited to lower protein concentrations, which are not applicable to late-stage development of high concentration therapeutics. In this work, we present a high throughput (HT) formulation workflow that enables screening at representative concentrations via integration of a micro-buffer exchange system with automated analytical instruments.
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  Regulatory Alert

FDA Said to be Ready to Endorse Pfizer and Moderna Boosters at Once

Later today the FDA is expected to authorize Moderna’s Covid-19 booster shot for all adults — a move that would come in tandem with the clearance of Pfizer-BioNtech’s booster for widespread use, two people with knowledge of the matter told POLITICO. The decision comes just days after Moderna officially asked the FDA to green-light its booster for Americans 18 and older and reflects the administration’s growing unease over the recent rise in Covid-19 cases across the nation. The FDA had previously planned to authorize Pfizer’s booster shot this week, but after Moderna filed a similar request on Wednesday, officials began debating whether to speed that authorization along as well, the people with knowledge of the matter said.
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  Discovery Alert

For Stem Cells, Bigger Doesn’t Mean Better

MIT biologists have answered an important biological question: Why do cells control their size? Cells of the same type are strikingly uniform in size, while cell size differs between different cell types. This raises the question of whether cell size is important for cellular physiology. The new study suggests that cellular enlargement drives a decline in function of stem cells. The researchers found that blood stem cells, which are among the smallest cells in the body, lose their ability to perform their normal function -- replenishing the body's blood cells -- as they grow larger. However, when the cells were restored to their usual size, they behaved normally again. The researchers also found that blood stem cells tend to enlarge as they age. Their study shows that this enlargement contributes to stem cell decline during aging.
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  Project Alert

$165 Million Biopharmaceutical Center ‘A Big Game Changer’ for University of Delaware 

When the Ammon Pinizzotto Biopharmaceutical Innovation Center opened at the University of Delaware’s STAR Campus in late February 2020, officials were excited to begin using the glimmering, $165 million facility meant to foster collaboration between different disciplines of science. Less than a month later, the pandemic dashed those plans, delaying the full occupancy of the building and postponing any public celebration of its completion. Recently, UD officials finally got to celebrate the opening of the building, holding a ribbon-cutting ceremony and donor recognition event. The six-story, 228,000-square-foot Ammon Pinizzotto Biopharmaceutical Innovation Center – called A.P. Bio for short – houses NIIMBL, the Delaware Biotechnology Institute, the Department of Biomedical Engineering and Biopharmaceutical Sciences.
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  Patent Alert

Continuous Countercurrent Spiral Chromatography 

A U.S. Patent for "Continuous Countercurrent Spiral Chromatography " was awarded to Chromatan on September 7, 2021. The present invention is a system, module and method for continuous countercurrent spiral chromatography are disclosed. The module includes an input port for receiving an input solution, a first mixer for mixing the input solution with a recycled solution to produce a first mixed output, a stage I separator for concentrating the first mixed output to produce a stage I solid fraction, a second mixer for mixing the stage I solid fraction from the stage I separator and an optional buffer solution to produce a second mixed output, and a stage II separator for concentrating the second mixed output to produce a stage II solid fraction which exits the module.
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  Solution Alert

Steam In Place SIP - A Comprehensive Overview of SIP, Existing Components, Piping Design, and the New Technology Used to Reduce Common Problem Occurrences

What are the rules and common piping practices employed to ensure that steam sterilization occurs on time without fail? What are SIP temperature validation alarms, or faults? Why do they occur? How does thermostatic steam trap operation affect the occurrence of temperature validation faults? What new technologies are available to mitigate common SIP problems? Specific answers to these questions will be covered in this white paper. To begin, let’s briefly review some fundamentals of process equipment steam sterilization (SIP), and the operating principles of sanitary balanced port thermostatic steam traps.
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  Humor Alert

  Fact Alert

The Stars Of "One Flew Over The Cuckoo’s Nest" Lived On The Hospital’s Ward During Production

All of the actors who played patients actually lived on the Oregon State Hospital psychiatric ward throughout production. The men personalized their sleeping quarters, spent their days on campus “get[ting] a sense of what it was to be hospitalized” (as actor Vincent Schiavelli put it), and interacting with real psychiatric patients.
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   Career Alert

Codexis
Associate Director, Upstream Bioprocess Development (BioTx)
Redwood City, CA
We are looking to hire an Associate Director to lead the Biotherapeutics Upstream Bioprocess Development team. In this role you will leverage your technical expertise and leadership skills to lead upstream process development and scale up of recombinant protein productions of biotherapeutic enzymes. Learn More

Abbott Laboratories
Scientist, Technology Development
San Diego, CA
Abbott is currently looking for dynamic individual, Scientist - Technology Development, with a proven track record of innovation in the areas of molecular amplification technologies, protein engineering and/or sample preparation who will help drive the design and development of a novel diagnostic point-of-use platform. Learn More

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

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