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Aspen Alert

Issue # 3587 | November 23rd, 2021      

   News Alert

BioPharma Manufacturing Getting Hit by Hackers Potentially Linked to Foreign Governments

The Bioeconomy Information Sharing and Analysis Center (BIO-ISAC) has revealed an ongoing effort, which involves a type of malware labeled “Tardigrade” that was first detected following a ransomware attack on an unnamed major biopharma manufacturing facility this spring. The same malware was found at a second biopharma manufacturing facility last month, leading to the release of the information this week in an effort to raise awareness among other companies in the sector to step up their cybersecurity efforts. Researchers at BioBright, a member of BIO-ISAC, described the hacking effort to The Hill as “A-level,” and cited potential involvement by a foreign government.
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Bluebird, After Delays, Gets Speedy FDA Review for Beta Thalassemia Gene Therapy

The FDA will decide whether to approve Bluebird bio's gene therapy for beta thalassemia by next May, granting the blood disease treatment a priority review, the biotech company said in a statement. If approved, the treatment, called beti-cel, would become the third gene therapy cleared in the U.S. for an inherited disease. Beti-cel consists of a patient's own stem cells, extracted and genetically modified to express a gene that's missing or dysfunctional in people with beta thalassemia, a rare condition that can require lifelong blood infusions. Bluebird won approval for beti-cel in Europe in 2019. But in August the drugmaker said it would withdraw the treatment from market, citing disagreements with European health systems over the drug's cost.
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FDA Says it Far Exceeded Projections for Inspections in FY2021

In an update to its Resiliency Roadmap for FDA Inspectional Oversight, the US FDA this week said that the number of domestic surveillance inspections it carried out in the second half of FY2021 was more than double the number it initially projected in the roadmap last spring. In its initial Roadmap, the FDA estimated that more than 15,000 domestic surveillance inspections that it planned to complete in FY2020 and FY2021 were postponed due to the pandemic, and that about 14% of those inspections could be conducted under a best-case scenario with a gradual transition to normal operations. The FDA now says it has exceeded those projections, as well as its projections for a swifter transition to normal operations, completing more than double the number of inspections it previously estimated it would be able to.
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   Quote Alert

   On This Day Alert

November 23rd Is Fibonacci Day

Fibonacci Day is an annual holiday that honors one of the most influential mathematicians of the Middle Ages. November 23 is celebrated as Fibonacci day because when the date is written in the mm/dd format (11/23), the digits in the date form a Fibonacci sequence: 1,1,2,3. A Fibonacci sequence is a series of numbers where a number is the sum of the two numbers before it.
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  TED Alert

The Magic Of Fibonacci Numbers

Math is logical, functional and just ... awesome. Mathemagician Arthur Benjamin explores hidden properties of that weird and wonderful set of numbers, the Fibonacci series. (And reminds you that mathematics can be inspiring, too!)
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  Poll Alert

Should sports teams for children under 14 have "mercy rules," which end games sooner once one team is leading by an insurmountable margin?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

Effect of Ambient Light on IgG1 Monoclonal Antibodies During drug Product Processing and Development 

Photostability studies are standard stress testing conducted during drug product development of various pharmaceutical compounds, including small molecules and proteins. These studies as recommended by ICH Q1B are carried out using no less than 1.2 × 106 lux-hours in the visible region and no less than 200 W h/m2 in UV light. However, normal drug product processing is carried out under fluorescent lamps that emit white light almost exclusively in the >400 nm region with a small UV quotient. We term these as ambient or mild light conditions. We tested several IgG1 monoclonal antibodies (mAbs 1–5) under these ambient light conditions and compared them to the ICH light conditions. All the mAbs were significantly degraded under the ICH light but several mAbs (mAbs 3–5) were processed without impacting any product quality attributes under ambient or mild light conditions.
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Survey Alert

How many pieces of equipment (Pumps, Sensors, Meters...) would you expect a low-cost, compact bioprocess controller to be able to manage? Please comment on your reason(s).

► 1 to 4
► 4 to 8
► 8 to 12
► 12 or More

Previous Survey Results:

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  Upstream 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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Event Alert

Biotech Boot Camp

Wednesday, January 29 to Wednesday, February 16, 2022

Frederick Community College is excited to announce the first "Biotech Boot Camp". This free 4-week training program is designed to teach participants the basic skills needed for entry-level positions in the biotech industry. The training program is a great opportunity for displaced workers and those interested in a career in biotech. Biotech Boot Camp will be held in person at Frederick Community College from January 19 to February 16, 2022, offering a hands-on training experience with a curriculum developed to address industry needs. The program will run for 4 hours, 4 days a week. Candidates must be over 18 years old and reside in Frederick County, Maryland to be considered for the bootcamp.
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 Downstream Alert

Single-Use Chromatography: Adapting to Manufacturing Scale

Single-use technologies offer the flexibility needed to meet the demands of multiproduct facilities. The capital investment is lower, and substantial time savings can be made when eliminating cleaning and cleaning validation procedures. While widely adopted in upstream production processes, what is required to move single-use technologies into downstream manufacturing scale? This article discusses strategies for meeting the ever-increasing upstream titers and volumes to prevent downstream purification from becoming a bottleneck.
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  Podcast Alert

Pool Table Physics with Dr. Dave Alciatore

Discover the history of billiards as we find the science hidden in this parlor sport. How did this game of the French aristocrats become what it is today? Did Gaspard-Gustave de Coriolis play pool? Learn about the Coriolis Effect and why the famous scientist was so interested in pool. Can you make a machine to play the perfect billiard game? We break down parabolic paths: does it work the same when the plane is horizontal? We discuss differential equations and how to get the perfect Massé shot to go around your opponent’s ball.
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  Fill/Finish Alert

How Do Your Freezing Choices Affect Your Drug Substance?

As freezing drug substance for storage and transport becomes ever more important, learn more about how freezing kinetics affect product quality. Discover how conventional, static freezing in bottles or bags inhibits activity retention and affects product stability, plate freezing helps minimize viability losses and extend shelf life and rapid thawing can reduce molecule degradation.
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  Regulatory Alert

BioMarin's Dwarfism Drug Voxzogo Could be Its Next Blockbuster, But Ethics Questions Loom Over the Launch 

BioMarin has won the FDA's go-ahead for its next big launch. But the drug's arrival may be unwelcome news for those who've built a community out of living full lives with dwarfism. The FDA approved Voxzogo, also known as vosoritide, for a form of dwarfism called achondroplasia. With the FDA nod, Voxzogo becomes the first treatment licensed in the U.S. for achondroplasia. And while BioMarin is celebrating the FDA approval, the arrival of Voxzogo may be unwelcome news for some in the achondroplasia community. Groups such as the Little People of America have worked hard to communicate the message that people with achondroplasia can live full lives, and they see the new medicine as a threat to their work, according to Stat News.
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  Discovery Alert

Wearable Tech Confirms Wear-and-Tear of Work Commute

Information about worker commutes from smartphones and fitness trackers can predict individual job performance, according to a Dartmouth-led study. The study confirms the behavioral and physical effects of commuting on work quality. The study also shows how data from personal tech devices can help improve employee productivity and satisfaction. "Your commute predicts your day," said Andrew Campbell, the Albert Bradley 1915 Third Century Professor of computer science at Dartmouth, the lead researcher and co-author of the study. "This research demonstrates that mobile sensing is capable of identifying how travel to and from the office affects individual workers."
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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

Abrasion Resistant Film for Biocontainers 

A U.S. Patent for an "Abrasion Resistant Film for Biocontainers" was awarded to MilliporeSigma on September 7, 2021. The present invention is a multilayered film for biocontainers, an abrasion-resistant substrate attached to the interior or the exterior side of the film wherein the substrate is one of a polymeric woven fibrous material or a polymeric non-woven fibrous material, a woven fibrous material or a non-woven fibrous material having metal fibers, a woven fibrous material or a non-woven fibrous material having glass fibers, or a woven fibrous material or a non-woven fibrous material having carbon fibers; a polymer backing to attach the substrate to the film, including one of polyolefins, polyurethanes and nylons; an outer protective layer disposed on the outside of the substrate to encapsulate the substrate...
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  Solution Alert

Perfusion Microbioreactor with Integrated Cell Retention Device

Cell culture media development requires high throughput in order to generate robust statistical models capable of identifying the critical components that need to be optimized. Currently, there is no commercially available cell retention device that can be used with high throughput systems (<100mL) in perfusion mode. In an effort to increase capability for perfusion media development we evaluated the Erbi perfusion microbioreactor system, a 2mL working volume system with an embedded filtration-based cell retention device. With Erbi Biosystems’ expertise in microfluidics and our expertise in perfusion animal cell culture, we have made significant improvements to the system. At this time, we are able to achieve a steady state of at 50x106vc/mL with a CHOZN®GS cell line producing a fusion protein and a CHOS cell line producing a mAb.
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  Humor Alert

  Fact Alert

The Fibonacci Appears In The Smallest To The Largest Objects In Nature

Simple equations involving the Fibonacci numbers can describe most of the complex spiral growth patterns found in nature.
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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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