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Aspen Alert

Issue # 3398 | March 3rd, 2021      

   News Alert

Merck to Dedicate a Manufacturing and Fill-Finish Facility to J&J for COVID-19 Vaccine

The U.S. COVID-19 vaccine program got a welcome jolt this week with the news that one of the biggest vaccine makers in the world, Merck & Co. will help make Johnson & Johnson’s one-dose jab, potentially doubling the supply from what J&J could achieve on its own. The unusual deal that will see the two rival drugmakers work together was brokered by the federal government as it works to expand manufacturing of the vaccine, which was granted emergency use authorization by the U.S. FDA on Saturday. Merck will dedicate two facilities in the U.S. to the effort with one providing “fill-finish” services, putting vaccine in vials for distribution, while the other will make the vaccine itself.
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BioPharma Industry Pushes FDA to Solve Growing Inspection Backlog

The U.S. FDA is under increasing pressure from the biopharma industry to address the growing backlog of drug inspections. From March through September, the FDA inspected just three plants outside the U.S., well below the 600-plus it visited in each of the prior two years, the Government Accountability Office said last month. The FDA has also struggled to keep up with inspections within U.S. borders, conducting just 52 during the same seven-month period last year, compared with roughly 400 each in 2019 and 2018. The effects of the FDA slowdown are already becoming apparent. In recent weeks, the agency has deferred or denied at least six drug approvals because it could not inspect manufacturing sites in the U.S. and abroad.
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Beijing Dismisses Alleged Chinese Hacking of Indian Vaccine Makers

China this week rejected an allegation by a cyber intelligence firm that a state-backed hacking group targeted the IT systems of two Indian coronavirus vaccine makers. Cyfirma told Reuters that hacking group APT10, known as Stone Panda, had identified gaps and vulnerabilities in the IT infrastructure and supply chain software of Bharat Biotech and the Serum Institute of India (SII), the world’s largest vaccine maker. In response, China’s foreign ministry stated “Without showing any evidence, the relevant party made baseless speculation, distorted and concocted facts, to malign a specific party. This behavior is irresponsible and has ulterior motive. China firmly opposes it,”
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   Quote Alert

   On This Day Alert

1985 - "Moonlighting," Which Blended Madcap Comedy With Serious "Whodunit" Drama, Aired its Two-Hour Pilot 

"Moonlighting" was the brainchild of Glenn Gordon Caron, who had made his mark in prime time as a producer of "Remington Steele," a forerunner which blended comedy and drama and starred then-unknown Pierce Brosnan and Stephanie Zimbalist. According to Caron, the inspiration for Moonlighting was a production of The Taming of the Shrew he saw in New York’s Central Park with Meryl Streep and Raul Julia.
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  TED Alert

Why Being Respectful To Your Coworkers Is Good For Business

Looking to get ahead in your career? Start by being respectful to your coworkers, says leadership researcher Christine Porath. In this science-backed talk, she shares surprising insights about the costs of rudeness and shows how little acts of respect can boost your professional success -- and your company's bottom line.
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  Poll Alert

Have you found yourself getting upset that friends/family are not observing the COVID-19 restrictions as closely as you?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

Integrating Upstream and Downstream Process Development Strategies for Mammalian Cell Derived Therapeutic Antibodies

Recent improvements in volumetric antibody productivity (often in excess of 5 g/L) have been achieved by advances in cell lines and upstream processing, but often lead to harvest material becoming more difficult to recover. These intensified upstream operations require a renewed prioritization of the integration of upstream and downstream process development to ensure product purification issues are taken into consideration, to avoid extensive and expensive clearance strategies downstream. Here, it was demonstrated that changes to upstream process parameters at the bioreactor stage of monoclonal antibody production affect product quantity and quality.
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Survey Alert

Would you prefer the sensors being used in your single-use applications be themselves single-use or reusable?

► Single Use
► Disposable

Previous Survey Results:

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  Upstream Alert

Developing In-Process Analytical Tools for Gene Therapy Applications

In this interview by Cell & Gene Therapy Insights, subject matter experts René Gantier, Director of Technology for Gene Therapy, Repligen, Ramsey Shanbaky, Bioprocess Applications Manager, C Technologies, and Jay West, Principal Scientist at Bristol Myers Squibb, discuss in-process analytical tools for gene therapy applications.
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Event Alert

Integrated Production Process of mRNA from E. coli to Highly Purified mRNA

Wednesday, March 10th, 2021

Aleš Štrancar (Presenter) 
Managing Director of BIA Separations, 
A Sartorius Company


In vitro transcription (IVT), the enzymatic process used for mRNA vaccines' production, is different from from biological fermentation processes as it requires linearized plasmid DNA. The linear isoform is produced with restriction enzymes from open circular and supercoiled pDNA. Employing a traditional pDNA manufacturing process, which removes linear and open-circular isoforms, will reduce the production yield. However, when pDNA and mRNA are treated as a single production process, the purification steps can be optimized, yields improved, and the overall production cost reduced. This will be presented in this webinar.
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 Downstream Alert

A Hydrophobic Interaction Chromatography Method Suitable for Quantitating Individual Monoclonal Antibodies Contained in Co-Formulated Drug Products 

A co-formulated monoclonal antibody (mAb) product containing two or more antibodies offers several therapeutic advantages. However, quantitating the individual antibodies in a co-formulated product is challenging due to the similar biochemical and biophysical properties of mAbs. To identify a method suitable to support the development of a co-formulated drug product with three mAbs, a hydrophobic interaction chromatography method was developed, utilizing a Dionex ProPac HIC-10 column, 100 mM phosphate buffer (pH 7.0), and an ammonium sulfate gradient. Compared to other methods that were evaluated, the HIC method showed the best separation, as well as accurate quantitation of the three mAbs in the co-formulated drug product. 
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  Podcast Alert

Presenting Coronavirus: Fact Vs. Fiction

This week, we’re sharing an episode of Coronavirus: Fact Vs. Fiction, a podcast from CNN. This episode is The Hunt for Disease X: As human activity ventures further into the wilderness, scientists believe more diseases will emerge. CNN Senior International Correspondent Sam Kiley takes Dr. Sanjay Gupta on a journey deep into the rainforests of the Democratic Republic of the Congo, where the hunt for the next pandemic pathogen continues.
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  Regulatory Alert

EMA Sets March 11th as Date for J&J Vaccine Meeting 

The EMA has announced an extraordinary meeting of its human medicines committee (CHMP) to evaluate the COVID-19 vaccine developed by Janssen, a Johnson & Johnson division. The aim of the March 11th meeting will be to “conclude the evaluation, if possible.” The US FDA issued an emergency use authorization for the one-shot adenovirus vaccine on February 27th after its vaccines advisory committee voted unanimously that the benefits outweighed the risks of authorizing the vaccine. Janssen’s COVID-19 vaccine, which participated in the US Operation Warp Speed vaccine accelerator program, showed efficacy figures topping 80% in protecting against severe and critical COVID-19 in global clinical trials conducted in places such as South Africa where concerning variants predominate. It was 100% effective in preventing hospitalizations. 
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  Discovery Alert

Discovery Offers Potential for Stripping Tumors of T Cell Protection

Immunologists at St. Jude Children's Research Hospital have discovered that tumors use a unique mechanism to switch on regulatory T cells to protect themselves from attack by the immune system. Surprisingly, the mechanism does not affect regulatory T cell function outside the tumor and may therefore limit the immune-associated toxicities of targeting regulatory T cells. The researchers showed that blocking tumor-associated regulatory T cell activity eliminated tumors cells in mice and sensitized the cells to cancer immunotherapy called anti-PD-1 therapy. The research appears in the journal Nature.
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  Project Alert

Avid Bioservices Begins Phase 2 of its $50 Million Myford Manufacturing Capacity Expansion Plan

Avid Bioservices has initiated Phase 2 of the company’s two-phase effort to expand the overall manufacturing capacity within its Myford facility. Work is now underway to further build out the company’s Myford facility to include a second manufacturing train with both upstream and downstream processing suites, known as Myford South. Avid’s decision to initiate Phase 2 of the Myford expansion was driven by an increase in projected customer demand for the company’s manufacturing services. Based on conceptual plans, the company expects the Myford South build out to take 18 to 24 months to complete at a cost of approximately $45 million to $55 million.
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  Patent Alert

Method and Systems for Isolation and/or Separation of Products from Production Processes

A U.S. Patent for "Method and Systems for Isolation and/or Separation of Products from Production Processes" was awarded to Smartflow Technologies on January 19th, 2021. The present invention relates to separation of desired target products from biological, plant, and waste-type material, wherein the desired target products include renewable fuels such as ethanol, biobutanol, and biodiesel, wherein the separation is conducted with a cross-flow filtration system having the ability to separate desired products from both non-viscous and viscous medium.
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  Solution Alert

How to Measure pH in TRIS-Containing Samples

TRIS buffers, which are often present in biological samples, can cause challenges in pH measurement. The interaction between classic silver-silver chloride electrolyte solutions and the key components of the TRIS base leads to junction blockage and shortened pH sensor lifespan. Selection of the appropriate reference system can allow improved pH sensor accuracy and extended lifetime.
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  Fact Alert

Bruce Willis Worked Some Really, Really Long Days 

When Willis was cast in Die Hard, he was mostly known for his role as private detective David Addison (Willis, pictured with co-star Cybill Shepherd) with on the television series Moonlighting. Willis was still shooting the TV show when the film went into production, meaning he was working on Moonlighting during the day before filming Die Hard at night.
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   Career Alert

Sartorius
Platform Development Specialist - Protein Based Therapies
Remote, CA & MA
The Platform Development Specialist is responsible for acting as an enabler for penetration of our products and technologies in customers’ processes in early stage development and making Sartorius the “partner of choice” to biopharma companies. The holder of this position will implement early stage seeding strategy by defining cross-portfolio packages for processes, support sales reps in identifying new opportunities and align benefits to create value for the early stage customers. Learn More CA | Learn More MA

ThermoFisher Scientific
Scientist II, Cell Culture
St. Louis, MO
As a member of the BioProcessing Collaboration Center, this position will help drive innovation by supporting development and refinement of Thermo Fisher Scientific biopharmaceutical production offerings (e.g., equipment, single-use technologies) to support improved manufacturability of biotherapeutics. Job ID: 137019BR Learn More

TeraPore Technologies
Director of Bioprocess Technology
South San Francisco, CA
TeraPore is seeking a technical leader to head the Bioprocess Engineering group. In this role, you will have the opportunity to be at the forefront of developing new precision bioseparation solutions enabled by nanomaterials to meet the challenges of manufacturing next generation biologic drugs such as cancer immunotherapies and vaccines. Learn More

Sartorius
Head of Confidence Virus Clearance Services
Boston Area, MA
The successful candidate will liaise with internal and external stakeholders establish a GLP-accredited virus clearance services operations; defining operational needs, hiring personnel, establishing best-in-class business processes and appropriate GLP quality systems, etc. Learn More

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