Pharmaceutical Technology Editors

Life science company Eppendorf has donated €20,000 (US$22,400) to the European Molecular Biology Laboratory (EMBL) to support the “Advancement of Women in Science” project, it was revealed in a Nov. 22, 2021 press release.

EMBL’s project is aimed at enabling women scientists to begin managerial careers in scientific fields. Eppendorf’s donation, which reinforces the corporate partnership between the company and EMBL, will allow 20 women postdocs to join the program for women scientists in managerial positions.

“To offset this disparity [between the genders in managerial positions in the scientific community], the EMBL took action in 2020 and initiated a program called ‘Leadership and Excellence for Aspiring Women Postdocs’ (LEAP) that includes a one-year mentoring and coaching program,” said Edith Heard, director general of EMBL, in the press release. “This generous donation from Eppendorf will enable 20 additional female postdocs to gain the qualifications they need for managerial careers. We hope that they go on to become group leaders, leading researchers and assistant professors in scientific fields.”

“Solidarity, tolerance, and diversity are the defining features of the cosmopolitan culture that Eppendorf fosters and the foundation of the company’s success,” added Eva van Pelt, Co-CEO of Eppendorf SE, in the press release. “The disparity between the number of men and women who hold managerial positions in the scientific community is a serious problem. Increasing the visibility of women in science is both a declared goal and an important concern at Eppendorf.”

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Eppendorf has donated €20,000 (US$22,400) to the European Molecular Biology Laboratory (EMBL) in support of the “Advancement of Women in Science” project.

Eppendorf Makes Donation to Support Women Working in Science

The European Commission (EC) has granted marketing authorization for Gilead’s Trodelvy (sacituzumab govitecan) to be used as a monotherapy to treat adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have already received two or more systemic therapies, with at least one of those for advanced disease. Gilead announced the positive outcome from the EC in a Nov. 23, 2021 press release.

Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate, which has been specifically directed to the Trop-2 receptor—a protein that is overexpressed in numerous types of epithelial tumors. The commission’s decision was based upon Phase III trial data, demonstrating the efficacy of Trodelvy in reducing the risk of death and improving survival in TNBC patients.

“The metastatic stage of TNBC is particularly challenging to treat and until now we have urgently needed new treatment options for people in Europe living with this condition,” said Véronique Diéras, senior medical oncologist head, Breast Cancer Group, Department of Medical Oncology, Centre Eugène Marquis, Rennes, France, in a company press release. “Today’s approval including second-line metastatic TNBC is significant for the community as it’s another important step forward in helping women with this disease live longer.”

“At Gilead, we push boundaries to deliver transformative science and novel treatment options that address urgent medical needs,” said Merdad Parsey, chief medical officer, Gilead Sciences. “We understand how difficult metastatic TNBC is to treat and we’re proud that Trodelvy can now offer a second-line treatment option with the potential to bring longer life to people living with this aggressive disease.”

The EC has granted marketing authorization for Gilead’s Trodelvy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer.

EC Grants Marketing Authorization to Gilead’s Trodelvy

MilliporeSigma announced the launch of its new ColorWheel flow cytometry portfolio on Nov. 16, 2021. The ColorWheel uses technology optimized for flow cytometry that allows users to select antibodies and dyes for assembly in any desired combination, resulting in an output of mix-and-match antibodies and dyes analogous to a primary conjugated antibody.

According to a company press release, multiplexing in flow cytometry can be difficult because researchers must consider instrument configuration, antigen expression and dye brightness balance, and antibody–dye combination availability. In this regard, the ColorWheel is designed to overcome these constraints by making it easier to build a new multiplex assay for samples with varying expression levels of antigen.

According to the press release, the ColorWheel:

Has the flexibility to pair any antibody with any dye in a ready-to-use, convenient format

Can be used in five minutes of hands-on time, minimizing necessary time and effort

Uses a preservative-free presentation that promotes sustainability and wider sample type compatibility

Delivers a lyophilized product, enhancing stability and allowing for ambient shipping.

MilliporeSigma’s new ColorWheel flow cytometry portfolio is designed to create antibodies and dyes analogous to a primary conjugated antibody.

MilliporeSigma Unveils ColorWheel Flow Cytometry Portfolio

Denali Therapeutics announced on Nov. 17, 2021, that its strategic partner Takeda Pharmaceutical Company has exercised an option, pursuant to an existing collaboration agreement between the two companies, to co-develop and co-commercialize DNL593 (PTV:PGRN), an investigational, brain-penetrant progranulin replacement therapy for the potential treatment of frontotemporal dementia-granulin (FTD-GRN).

Denali and Takeda entered into a collaboration agreement in January 2018. Takeda was granted an option for three programs, including PTV:PGRN. Exercising its option, Takeda now obtains the right to develop and commercialize DNL593 jointly with Denali. The companies will share the development and commercialization costs equally, and, if applicable, profits on a worldwide basis.

“We are excited to advance our collaboration with Takeda on the development of DNL593 as a potential treatment for people with FTD-GRN,” said Ryan Watts, PhD, CEO of Denali. “Pending acceptance of regulatory submissions, DNL593 will be the sixth therapeutic candidate from our broad pipeline, and our second Transport Vehicle (TV)-enabled molecule, in clinical development. This progress underscores the potential of our TV platform technology, which is designed to enable and enhance [the] delivery of biologic therapeutics to the brain for the treatment of neurodegenerative diseases.”

Takeda has exercised an option to co-develop and co-commercialize an investigational, brain-penetrant progranulin replacement therapy for the potential treatment of frontotemporal dementia-granulin.

Denali Therapeutics and Takeda to Jointly Develop and Commercialize Investigational Treatment for FTD-GRN

In a Nov. 17, 2021, press release, GlaxoSmithKline (GSK) and Vir Biotechnology announced United States government contracts totaling approximately $1 billion to purchase sotrovimab, an investigational monoclonal antibody (mAb) for the early treatment of COVID-19. FDA granted sotrovimab an Emergency Use Authorization (EUA) in May 2021. GSK will supply doses of sotrovimab to the US government by Dec. 17, 2021, to expand nationwide access to sotrovimab for patients.

In addition, the US government will have the option to purchase additional doses through March 2022. The total number of sotrovimab doses secured through binding agreements—including the contracts with the US government—is now more than 750,000 doses globally. This includes the previously announced joint procurement agreement with the European Commission.

Sotrovimab is an FDA EUA authorized investigational single-dose intravenous (IV) infusion SARS-CoV-2 mAb. Under the EUA, sotrovimab can be used as a treatment for mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older and weighing more than 88 pounds). These patients must have positive test results for COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death.

The Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response through the Department of Defense, funded the US government purchase.

United States government contracts total approximately $1 billion to purchase sotrovimab, an investigational mAb. 

US Government to Pay $1 Billion for GSK and Vir Biotechnology’s Early Treatment of COVID-19

Launched in November 2021, Sartorius’ newly redesigned Sartolab RF|BT 150–1000 vacuum filtration units offer faster and higher capacity filtration while allowing for enhanced physical stability for a wide range of sample types. The modifications to the product’s design include:

Increased membrane surface area to facilitate optimal filtration

A new 0.45 µm polyethersulfone membrane in place of the 0.45 µm cellulose acetate membrane to increase flow rate while keeping the same low-protein binding properties

An optimized center of gravity to increase stability of the units

Able to be directly used on the Sartolab Multistation for parallel filtration

In addition, the new vacuum filtration units are available in three different pore sizes to meet the needs of most applications, as follows:

0.22 µm for sterile filtration of cell culture media, buffers, and reagents

0.45 µm for clarification of aqueous and viscous solutions

“We are excited to introduce our updated Sartolab vacuum filtration units, which build upon the benefits and ergonomic design of the original units,” said Catherine Leluan, product manager, Sartorius, in a Nov. 1, 2021 press release. “The redesign of these units exemplifies our commitment to engineer products that accelerate and streamline workflows, are user-friendly and are well-suited for the busy laboratory setting. In addition, improvement in our manufacturing controls [is] expected to lead to increased robustness of supply to help meet growing market demand.”

Sartorius’ newly redesigned vacuum filtration units are designed to allow for faster and higher-capacity filtration while offering enhanced stability for sample processing.