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Aspen Alert

Issue # 3715  |  May 20th, 2022      

   News Alert

FDA Explains Plans to Bolster Cell and Gene Therapy Approvals Through Wider Messaging

Wilson Bryan, Director of the US FDA’s Office of Tissues and Advanced Therapies (OTA) in the agency’s Center for Biologics Evaluation and Research, told a meeting this week of the Association for Cell and Gene Therapies (ASGCT) that the division is undertaking a series of internal measures to improve communications with sponsors and to widen its messaging. These measures are being taken to compensate for a lack of individual attention to applications for cell and gene therapies as the result of the growing number of cell and gene therapies amidst staffing constraints. These measures include the issuance of more “group communications” through guidance, workshops and webinars.
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Another Biotech That Went Public in Pandemic Boom Aims to Weather the Bear Market Through R&D Cutbacks

The bear market is showing no signs of letting up, with a French biotech that IPO’ed during the pandemic boom feeling the heat. Nanobiotix, a French biotech focusing on new treatments for cancer, is cutting back on preclinical research and amending some of its ongoing studies to stay afloat, the company said in its first quarter report this week. The cuts are aimed at prioritizing its lead program for advanced head and neck squamous cell carcinoma, Nanobiotix said. Though the company reported it was “reducing satellite office facilities,” a Nanobiotix spokesperson told Endpoints News this involves moving hybrid employees to fully remote rather than laying off staff.
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CDC Recommends Covid Boosters for Kids Ages 5 to 11 After Advisory Committee Vote

A key vaccine advisory panel voted this week to recommend that children between the ages of 5 and 11 should be offered a third dose of the Pfizer-BioNTech Covid-19 vaccine at least five months after they received their second dose. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, endorsed the panel’s recommendation later that day. The CDC also now recommends that those who are 12 and older and immunocompromised and all people over the age of 50 should receive a second booster — that is, a fourth dose of vaccine — at least four months after their first dose. Previously, the agency had allowed those groups to get a fourth dose but had not made a clear recommendation.
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   Quote Alert

   On This Day Alert

National Endangered Species Day

An endangered species is a species that is very likely to become extinct in the near future, either worldwide or in a particular political jurisdiction. Endangered species may be at risk due to factors such as habitat loss, poaching and invasive species. The International Union for Conservation of Nature (IUCN) Red List lists the global conservation status of many species, and various other agencies assess the status of species within particular areas. Many nations have laws that protect conservation-reliant species which, for example, forbid hunting, restrict land development, or create protected areas. Some endangered species are the target of extensive conservation efforts such as captive breeding and habitat restoration.
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  TED Alert

The Dawn of De-Extinction. Are You Ready?

Throughout humankind's history, we've driven species after species extinct: the passenger pigeon, the Eastern mountain lion, the dodo... But now, says Stewart Brand, we have the technology (and the biology) to bring back species that humanity wiped out. So -- should we? Which ones? He asks a big question whose answer is closer than you may think.
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  Poll Alert

If you had to choose, would you rather be smart and sad, or dumb and happy?

► Smart and Sad
► Dumb and Happy

Previous Poll Results:

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  Bioprocess Alert

Capillary and Microchip Electrophoresis Method Development for Amino Acid Monitoring During Biopharmaceutical Cultivation

The increased use of biopharmaceuticals calls for improved means of bioprocess monitoring. In this work, capillary electrophoresis (CE) and microchip electrophoresis (MCE) methods were developed and applied for the analysis of amino acids (AAs) in cell culture supernatant. In samples from different days of a Chinese hamster ovary cell cultivation process, all 19 proteinogenic AAs containing primary amine groups could be detected using CE, and 17 out of 19 AAs using MCE. The relative concentration changes in different samples agreed well with those measured by high-performance liquid chromatography (HPLC). Compared to the more commonly employed HPLC analysis, the CE and MCE methods resulted in faster analysis, while significantly lowering both the sample and reagent consumption, and the cost per analysis.
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Survey Alert

Is continuous bioprocessing Science Fiction or Science Fact today?

► Science Fact
► Science Fiction

Previous Survey Results:

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  Upstream Alert

A Comprehensive Comparison of Mixing and Mass Transfer in Shake Flasks and Their Relationship with MAb Productivity of CHO Cells

The selection of highly recombinant protein (RP)-productive Chinese hamster ovary (CHO) cell lines is widely carried out in shake flasks. It is assumed that increases in the operating parameters in shake flasks lead to impairments in cell growth and RP production. These effects in cells metabolism are widely associated with high mass transfers and hydrodynamic stress. This study examined the impact of commonly used operational parameters on growth and specific productivity (qP) of two CHO cell lines differentially secreting a humanized anti-hIL8 monoclonal antibody (mAb) and cultured in 250 ml flasks. The evaluated parameters are filling volume (10, 15, and 20%), shaking frequency (60 and 120 revolutions per minute -rpm-), and orbital diameter (25.4 and 19 mm).
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Event Alert

GMP Biomanufacturing Solutions

Wednesday, June 15th, 2022

Commercial scale stainless steel bioreactors for GMP require modifications aligned to each specific process.  Getinge, formerly Applikon Biotechnology, has been a trusted partner for commercial stainless-steel systems for over 30 years.  This webinar offers a window into how a typical stainless steel project proceeds through the Getinge Applikon manufacturing site in Delft NL.
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 Downstream Alert

Behavior of Weakly Adsorbing Protein Impurities in Flow-Through Ion-Exchange Chromatography

Flow-through ion-exchange chromatography is frequently used in polishing biotherapeutics, but the factors that contribute to impurity persistence are incompletely understood. A large number of dilute impurities may be encountered that exhibit physicochemical diversity, making the flow-through separation performance highly sensitive to process conditions. The analysis presented in this work develops two novel correlations that offer transferable insights into the chromatographic behavior of weakly adsorbing impurities. The first, based on column simulations and validated experimentally, delineates the relative contributions of thermodynamic, transport, and geometric properties in dictating the initial breakthrough volumes of dilute species.
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  Podcast Alert

Talking Intellectual Property with Sara Holland

Intellectual Property has a funny relationship with research and innovation. Sara Holland is a patent attorney at Potter Clarkson an expert in Synthetic Biology IP. She talks us through the steps in identifying if your research could be protected, what goes into making a patent, and dispels the rumors around publishing vs patenting - you can have it all!
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  Fill/Finish Alert

Subcutaneous Delivery of High-Dose/Volume Biologics: Current Status and Prospect for Future Advancements

Subcutaneous (SC) delivery of biologics has traditionally been limited to fluid volumes of 1–2 mL, with recent increases to volumes of about 3 mL. This injection volume limitation poses challenges for high-dose biologics, as these formulations may also require increased solution concentration in many cases, resulting in high viscosities which can affect the stability, manufacturability, and delivery/administration of therapeutic drugs. Currently, there are technologies that can help to overcome these challenges and facilitate the delivery of larger amounts of drug through the SC route. This can be achieved either by enabling biologic molecules to be formulated or delivered as high-concentration injectables (>100 mg/mL for antibodies) or through facilitating the delivery of larger volumes of fluid (>3 mL).
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  Regulatory Alert

EMA Seeks Feedback on Remote Batch Certification Post-Pandemic

The European Medicines Agency (EMA) has proposed allowing qualified persons (QPs) to remotely certify batches routinely even after pandemic-related travel barriers are over. When the pandemic hit, manufacturers operated in business continuity mode and EMA posted guidance on regulatory flexibility to enable companies to minimize the risk of shortages while maintaining high standards of quality, safety and efficacy. EMA recognized that QPs needed to adapt to the pandemic environment and allowed remote batch certification when they were unable to visit the site in person. Now, the GMDP Inspectors Working Group is reviewing these flexibilities and has released a draft question and answer document on their current thinking.
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  Discovery Alert

CRISPR-Based Strategy Edits Multiple Genes and Could Treat Polygenic Diseases

A genome-editing strategy developed at Rice University can correct dozens of errors at the same time with high precision and efficiency, a possible breakthrough for those who suffer from diseases caused by a combination of mutations. The "drive-and-process" array, DAP for short, also appears to be highly adept at avoiding off-target edits, errors that have plagued earlier gene-editing strategies. Engineer Xue Sherry Gao and graduate student and lead author Qichen Yuan of Rice's George R. Brown School of Engineering introduced their unique CRISPR array architecture in Nature Communications. Their technique could both simplify and advance the art of gene editing, not only for human diseases but also for basic biology research and crop engineering.
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  Project Alert

Cytiva Opening New Facility in Switzerland

Global life sciences company Cytiva is opening a new 80,000 sq. ft. manufacturing facility in Grens, Switzerland on May 31, 2022. The site will manufacture single use kits for the Sepax and Sefia cell processing systems, as well as consumables for Xuri cell expansion systems. It will also serve as a Center of Excellence for Cytiva’s cell and gene therapy business and will be a base for European customer training programs. The site will be home to 250 associates. An opening ceremony will be held on May 31 followed by a LinkedIn Live Broadcast on June 2. The existing site in Eysins will continue operations through 2023, while full production transfers to the new site in Grens.
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  Patent Alert

Efficient Impurity Removal Using a Diafiltration Process

A U.S. Patent Application for "Efficient Impurity Removal Using a Diafiltration Process" from Janssen Biotech was published on March 24th, 2022. The present invention is a method for purifying a viral vector from a solution including the viral vector and host cell proteins (HCP) is provided. The method includes circulating the solution across an ultrafiltration/diafiltration membrane using tangential flow filtration (TFF) mode with continuous addition of diafiltration buffer. The method further includes filtering the solution across the ultrafiltration/diafiltration membrane to provide a permeate and a retentate. The retentate is collected such that a purified viral vector solution is obtained and retained in the retentate. A volume of the retentate is kept constant by the continuous addition of diafiltration buffer and the HCP is filtered out via the permeate.
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  Solution Alert

Stem Cell Cultivation in Bioreactors: Increasing hiPSC Yield

Human induced pluripotent stem cells (hiPSCs) and their differentiated progeny provide the tool set for innovative approaches in regenerative medicine. Stirred-tank bioreactors are promising cultivation systems, as they have the capacity to produce high cell numbers, allowing scale-up and cutting-edge opportunities for improving the control of growth parameters, with numerous benefits, the foremost of which is improved cultivation reproducibility. Increasing cell density is a vital component of research in stem cell bioprocessing. In this interview, Dr. Robert Zweigerdt from Hannover Medical School, Germany explains, how his team reached a culture yield of 35 million hiPSCs per mL.
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  Humor Alert

Bradford Veley

  Fact Alert

1 in 6 Species Could be Extinct by the End of this Century

A 2020 study by University of Arizona researchers detailed estimates of global extinction from climate change by 2070. By combining information on recent extinctions from climate change, rates of species movement and different projections of future climate, they estimate that one in three species of plants and animals may face extinction. Their results are based on data from hundreds of plant and animal species surveyed around the globe. John J. Wiens of the Department of Ecology and Evolutionary Biology at the University of Arizona said, "If we stick to the Paris Agreement to combat climate change, we may lose fewer than two out of every 10 plant and animal species on Earth by 2070. But if humans cause larger temperature increases, we could lose more than a third or even half of all animal and plant species, based on our results."
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   Career Alert

Zoetis 
Associate Director / Sr. Principal Scientist - Downstream Process Development 

Kalamazoo, MI
The Senior Principal Scientist in downstream bioprocess development (DSP) plays a vital role in the Zoetis biopharmaceutical and vaccine strategies for veterinary medicine. The successful applicant will be a team leader overseeing the development of purification processes in support of global product development. Learn More

Amyris, Inc. 
Associate Scientist 2 – Fermentation 

Emeryville, CA
Team the Associate Scientist will be responsible for executing fermentation experiments in support of our R&D deliverables.  The successful candidate will contribute toward strain and process improvement in a fast paced, team-oriented research operations setting and will contribute to improving lab effectiveness.  Learn More

Merck
Building Automation Global Lead (Remote Role) 

Rahway, NJ
This role will work within the Building Automation Systems (BAS) Center of Excellence to provide technical guidance, lead sub teams, implement proof of concepts, and consult in all aspects of solutions. This role will also include supporting site operational teams in their day-to-day challenges of operating BAS for all aspects of lifecycle management. Learn More

Sorrento Therapeutics 
Process Development and Manufacturing Associate 

San Diego, CA
Sorrento Therapeutics (“Sorrento”) is seeking an experienced Process Development and Manufacturing Associate II who will be responsible for manufacturing tasks including mammalian cell culture, cell banking, media preparation and process develop for production of clinical and commercial products. Learn More

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