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Aspen Alert

Issue # 3586 | November 22nd, 2021      

   News Alert

BioMarin Sues Former Engineer for Allegedly Stealing Trade Secrets

BioMarin, in a lawsuit filed in San Francisco federal court, has accused a former engineer who left the company for one of its main competitors in the gene-therapy industry of stealing more than 1,800 confidential files related to its manufacturing processes. BioMarin has asked the court to block Gerardo Caraballo, who joined Sangamo Therapeutics earlier this month, from possessing, sharing, or using its confidential information, and to turn over any money he made from misusing its trade secrets. Caraballo was a senior engineer at BioMarin and allegedly gave his resignation notice in October without indicating where he was going. The complaint said an internal investigation uncovered that Caraballo had downloaded its files to a USB device a week and a half before resigning.
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Professor Under Fire for Undisclosed Chinese Military Ties

A Chinese professor at the University of Copenhagen in Denmark is under scrutiny over undisclosed ties to the Chinese military. According to a Reuters report, the professor allegedly conducted genetic research with the military without revealing that relationship to his employer. According to the report, Guojie Zhang is a professor at the university and is also employed by China-based BGI Group, a Chinese genome-sequencing company that was formerly known as the Beijing Genomics Institute. BGI Group provides a significant amount of funding for research conducted at the University of Copenhagen and has its European headquarters on its campus.
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FDA Delays Its Decision on Bristol Myers' $13B Heart Drug Another Three Months 

Recently, Bristol Myers Squibb marched out long-term data for its heart drug mavacamten ahead of what execs had hoped would be a positive FDA decision in January. But regulators are saying they need a bit more time to think. The FDA has extended mavacamten’s PDUFA date three months, from Jan. 28 to April 28, Bristol Myers has announced. The news came just a few days after independent drug pricing watchdog ICER raised concerns about the candidate’s long-term safety in its final evidence report. Mavacamten, a myosin inhibitor, was the centerpiece of BMS’ $13 billion MyoKardia buyout last October.
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   Quote Alert

   On This Day Alert

1900 - First Mercedes Goes For A Test Drive

On November 22, 1900, the first car to be produced under the Mercedes name is taken for its inaugural drive in Cannstatt, Germany. The car was specially built for its buyer, Emil Jellinek, an entrepreneur with a passion for fast, flashy cars. Jellinek had commissioned the Mercedes car from the German company Daimler-Motoren-Gesellschaft: it was lighter and sleeker than any car the company had made before, and Jellinek was confident that it would win races so handily that besotted buyers would snap it up. (He was so confident that he bought 36 of them.) In exchange for this extraordinary patronage, the company agreed to name its new machine after Jellinek’s 11-year-old daughter, Mercedes.
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  TED Alert

Want To Be Happy? Be Grateful

The one thing all humans have in common is that each of us wants to be happy, says Brother David Steindl-Rast, a monk and interfaith scholar. And happiness, he suggests, is born from gratitude. An inspiring lesson in slowing down, looking where you're going, and above all, being grateful.
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  Poll Alert

Would you be willing to eat food where the ingredients contained insects regularly as part of your diet?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

Evidence-Based Guidelines for Controlling pH in Mammalian Live-Cell Culture Systems

A fundamental variable in culture medium is its pH, which must be controlled by an appropriately formulated buffering regime, since biological processes are exquisitely sensitive to acid–base chemistry. Although awareness of the importance of pH is fostered early in the training of researchers, there are no consensus guidelines for best practice in managing pH in cell cultures and reporting standards relating to pH are typically inadequate. Furthermore, many laboratories adopt bespoke approaches to controlling pH, some of which inadvertently produce artefacts that increase noise, compromise reproducibility or lead to the misinterpretation of data. Here, we use real-time measurements of medium pH and intracellular pH under live-cell culture conditions to describe the effects of various buffering regimes.
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Survey Alert

Is there a need in our community for a low cost, compact bioprocess controller? Please comment on your reason(s).

► Yes
► No

Previous Survey Results:

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  Upstream Alert

Real-Time Quantification and Supplementation of Bioreactor Amino Acids to Prolong Culture Time and Maintain Antibody Product Quality

Real-time monitoring of cell cultures in bioreactors can enable expedited responses necessary to correct potential batch failure perturbations which may normally go undiscovered until the completion of the batch and result in failure. Currently, analytical technologies are dedicated to real-time monitoring of bioreactor parameters such as pH, dissolved oxygen, and temperature, nutrients such as glucose and glutamine, or metabolites such as lactate. Despite the importance of amino acids as the building blocks of therapeutic protein products, other than glutamine their concentrations are not commonly measured. Here, we present a study into amino acid monitoring, supplementation strategies, and how these techniques may impact the cell growth profiles and product quality.
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Event Alert

Everything You Need to Know About Accuracy, Precision, Drift Etc. 

Tuesday, November 23, 2021

When researching the purchase of a new measuring device, you will be confronted with a wide variety of information on the measuring accuracies of the device in the data sheets.  Let's talk about the following questions:
•    But what exactly does precision mean and what is the difference to accuracy?
•    What is drift and why should you not miss the regular calibrations?
•    What exactly do the specifications mean for you as a user?  
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 Downstream Alert

Silica Resins and Peptide Ligands to Develop Disposable Affinity Adsorbents for Antibody Purification

A study is presented on the use of porous silica resins with tailored properties to develop affinity adsorbents for the purification of immunoglobulin G (IgG). Chromatorex® silica resins were utilized to study the dependence of IgG binding upon functional group density, pore size, and specific surface area. The IgG-binding peptide HWRGWV was chosen to demonstrate the potential of combining inexpensive substrates and ligands into efficient, yet disposable, adsorbents. The static binding capacity (SBC) of silica-peptide adsorbents depends significantly on surface area and pore size, yet minimally on ligand density. These results demonstrate that porous silica, a non-traditional substrate for protein purification, shows great promise as potentially single-use affinity adsorbent for protein purification.
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  Podcast Alert

Democratizing Drug Discovery

The ability to discover new drugs can be limited by the tools and technologies small companies can access. Alloy Therapeutics says it democratizing access to a set of technologies and capabilities that are foundational for discovering and developing biologics. We spoke to Errik Anderson, CEO of Alloy Therapeutics, discusses the challenges of drug discovery the company is seeking to address, its business model, and the dealmaking it has done to build beyond platform technologies to become involved in the discovery and development of therapeutic candidates.
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  Fill/Finish Alert

Low Volume Aseptic Filling of Monoclonal Antibodies 

A new, rapidly growing field of application is the therapy of eye diseases using monoclonal antibodies which have to be injected directly into the eye. The human eye is very sensitive to the amount of fluid to be administered and for this reason the volume to be injected is limited to 50 - 100 µL. This volume must be filled before application under strict safety regulations (sterility, particle count etc.) before it can be made available to the patient. The aim of this PhD thesis was to investigate the entire process of aseptic filling < 200 µL and to close the gap to accurate and precise standard filling volumes in the higher volume range.
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  Regulatory Alert

CDC Decides to Allow COVID-19 Vaccine Boosters for All Adults 

The Centers for Disease Control and Prevention is expanding eligibility for COVID-19 vaccine booster shots to all adults ages 18 and up. The agency published its new recommendations as health officials sound the alarm over rising cases around the country. "Booster shots have demonstrated the ability to safely increase people's protection against infection and severe outcomes and are an important public health tool to strengthen our defenses against the virus as we enter the winter holidays. Based on the compelling evidence, all adults over 18 should now have equitable access to a COVID-19 booster dose," CDC Director Dr. Rochelle Walensky said in a statement.
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  Discovery Alert

Novel Artificial Genomic DNA Can Replicate and Evolve Outside the Cell 

Professor Norikazu Ichihashi and his colleagues at the University of Tokyo have successfully induced gene expression from a DNA, characteristic of all life, and evolution through continuous replication extracellularly using cell-free materials alone, such as nucleic acids and proteins for the first time. The ability to proliferate and evolve is one of the defining characteristics of living organisms. However, no artificial materials with these characteristics have been created. In order to develop an artificial molecular system that can multiply and evolve, the information (genes) coded in DNA must be translated into RNA, proteins must be expressed, and the cycle of DNA replication with those proteins must continue over a long period in the system.
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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 for Enhancing Filtration Yields in Tangential Flow Filtration System 

A U.S. Patent for a "Method for Enhancing Filtration Yields in Tangential Flow Filtration System " was awarded to Cytiva on September 7, 2021. The present invention is for a process for enhanced recovery of a biological fluid from an activated crossflow filtration system, the process comprising: a. inducing an internalized pressurized countercurrent flow throughout the activated crossflow filtration system by activating an internal pump fluidically coupled to a sterile air source at a first end of the activated crossflow filtration system to cause said biological fluid to flow in a flow direction from the sterile air source toward a drain valve and opposite to a crossflow direction, b. recovering said biological fluid at the drain valve fluidically coupled at a second end opposite the first end of the activated crossflow filtration system, wherein the crossflow direction is along a fluid loop...
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  Solution Alert

GSK: Optimizing Your Experimentation Process Using JMP 

Learn how GSK’s Design of Experiments approach has resulted in a more efficient development process and delivered greater understanding and control of their drug production processes. There are different approaches to designing your experimental strategy and here we will share one based on the sequential use of Design of Experiments (DoE) in JMP to help you build an understanding of which factors can influence your reaction. Whether you are looking at ways to increase the yield, decrease the impurities or design a reproducible process, Design of Experiments can provide some useful insights in the most efficient way possible. GSK has devised a DoE methodology using JMP that has accelerated their development of new drugs and robust production processes.
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  Humor Alert

  Fact Alert

Today Is Love Your Freckles Day

Among the most fascinating and amazing facial features that exist are freckles. You don’t have to be a redhead to have been blessed with a dusting of them. You’ll find freckled folk with a variety of skin tones and complexions, and there can be a smattering on different parts of the body. They’re a feature that many people find mysterious and, like dimples, attractive. Click the link to learn more fascinating and fun facts about these facial features.
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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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