Pharmaceutical Technology Editors

Researchers of Karl Mechtler’s Group at the Research Institute for Molecular Pathology (IMP) in Vienna have achieved integration of their ultra-sensitive second-generation µPAC micro-Chip technology into their advanced single cell proteomics workflow, according to PharmaFluidics, a provider of life sciences instruments.

In a newly published joint study (available on bioRxiv), results showed a 10-fold increase in detection sensitivity, which was achieved using PharmaFluidics’ second-generation µPAC technology in an optimized workflow, as compared to previous reports, the company stated in a Feb. 17, 2021 press release. Key results in the study include untargeted and unbiased analysis achieving identification depth of over 2000 protein groups from as little as 500 picogram of HeLa protein tryptic digest.

“The microstructured and extremely reproducible µPAC microfluidic devices are conducive to the generation of high-quality data. With the further downscaling of the critical dimensions in our second-generation technology from 2.5 µm to 1.25 µm, we are now definitely opening a new league in proteomics LC [liquid chromatography], as indicated by the order of magnitude improvement in sensitivity for limited sample workflows,” said Paul Jacobs, co-founder and chief operating officer at PharmaFluidics, in the press release.

“We are grateful to IMP researchers for bringing PharmaFluidics’ technology to the forefront of protein biology, and to our own staff for relentless support to their fellow-scientists,” added Johan Devenyns, CEO of PharmaFluidics, in the press release.

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The new ultra-sensitive second-generation micro-chip technology is a key enabler in advanced single-cell proteomics workflow.

PharmaFluidics Offers Second-Gen µPAC Technology for Single Cell Proteomics

Inoculations with the first one-dose vaccine to combat COVID-19 are slated to begin in the United States in the first week of March 2021, after FDA issued an Emergency Use Authorization (EUA) for Janssen’s adenovirus type 26 (Ad26) vaccine on Feb. 27, 2021.

FDA announced the EUA following the unanimous recommendation of the vaccine by FDA's Vaccines and Related Biological Products Advisory Committee on Feb. 26. Two days later, on Feb. 28, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention endorsed safety and effectiveness of the vaccine for individuals age 18 and older.

"This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world—all of whom shared a goal of bringing a single-shot vaccine to the public," said Alex Gorsky, chairman and chief executive officer at Johnson & Johnson in a press statement. "We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world."

The EUA for the vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The company reported in a press statement that it plans to file for a biologics license application with FDA later in 2021. The company “is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use,” according to the press statement.

The vaccine, developed on the company’s AdVac vaccine platform, uses Ad26 to deliver a piece of the DNA that is used to make the spike protein of the SARS-CoV-2 virus; the vaccine triggers the human immune system to produce an immune response against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Effectiveness data from an ongoing randomized, placebo-controlled study of nearly 40,000 participants found the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.

Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination, FDA reported.

Clinical trial participants reported mild to moderate side effects including pain at the injection site, headache, fatigue, muscle aches, and nausea following vaccination, which lasted 1–2 days. Data are not available to demonstrate how long the vaccine will provide protection, or if it prevents transmission of SARS-CoV-2 from person to person.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, in an FDA press statement. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”

Johnson & Johnson estimates the vaccine will remain stable for two years at -4 °F (-20 °C), and up to three months at routine refrigeration at temperatures of 36–46 °F (2 to 8 °C).

The vaccine will be distributed by the US government with several million doses in the initial shipment. Johnson & Johnson expects to deliver 20 million doses by the end of March 2021 and 100 million single-shot vaccines during the first half of 2021.

Johnson & Johnson has applied for emergency approval with the European Medicines Agency, the World Health Organization, and in several countries worldwide.

anssen Pharmaceutical Companies of Johnson & Johnson

Distribution of the first one-dose vaccine for COVID-19 to start in early March.

J&J Vaccine Approved for Emergency Use

Seven Bridges, a bioinformatics ecosystem provider, announced on Feb. 24, 2021 that it is supporting Pfizer’s development of a data management and collaboration solution for its single-cell ribonucleic acid sequencing (scRNASeq) data.

Under the terms of the partnership, Seven Bridges will centralize and manage terabytes of raw and processed scRNASeq data using its cloud-based bioinformatic analysis platform while working to expand Pfizer’s cloud platforms and capabilities, Seven Bridges said in a company press release.

"Interpreting large-scale, complex transcriptomics data is critically important for understanding the molecular and cellular basis of disease," said Enoch Huang, vice-president, Medicinal Sciences, Pfizer, in the press release. "We are confident that by working with the unique multi-cloud technology developed by Seven Bridges and by benefiting from the depth and breadth of their expertise in bioinformatics and cloud computing, their solution will assist us in maximizing the value of the data we generate."

"Seven Bridges believes that genomics—and single-cell RNA sequencing in particular—will continue to play an increasingly vital role in the discovery of novel drugs and vaccines," said Bill Moss, CEO, Seven Bridges, in the press release. "We are thrilled that Pfizer has chosen our platform to help the company address these unique data management needs. And we look forward to supporting the development of a scRNASeq data storage solution that meets Pfizer's research and development requirements."

Through the partnership, Seven Bridges will centralize and manage terabytes of raw and processed scRNASeq data using its cloud-based bioinformatic analysis platform while working to expand Pfizer’s cloud platforms and capabilities.

Seven Bridges to Support Pfizer’s Data Management Solution for Single-Cell RNA Sequencing

Novo Nordisk announced on Feb. 25, 2021 that it is investing DKK 500 million (US$80 million) into the expansion of its facilities at its production site in Måløv, Denmark.

Currently, the facility manufactures products for oral diabetes treatment and will be expanded to increase capacity for these products, Novo Nordisk said in a company press release. The expansion is set to be completed in 2022.

“This investment in our production facilities in Måløv is an important step in building and ensuring future capacity for production of Rybelsus (oral semaglutide). Måløv is currently our cornerstone in the production of oral semaglutide, and it is critical that we invest timely in capacity expansion to meet the future demands,” said Henrik Steen Jensen, corporate vice-president for Novo Nordisk oral semaglutide production, in the press release.

Currently, the facility manufactures products for oral diabetes treatment and will be expanded to increase capacity for these products.

Novo Nordisk to Invest $80 million into the Expansion of its Denmark Production Site

Merck, known as MSD outside of the United States and Canada, announced on Feb. 25, 2021 that it has acquired Pandion Therapeutics, a US-based clinical-stage biotechnology company, for $1.85 billion.

Through the acquisition, Merck will have access to Pandion’s pipeline of precision immune modulators targeting critical immune control nodes, including its lead candidate, PT101, an engineered interleukin (IL)-2 mutein fused to a protein backbone designed to activate and expand regulatory T cells (Tregs) for the treatment of ulcerative colitis and other autoimmune diseases, Merck said in a company press release.

“This acquisition builds upon Merck’s strategy to identify and secure candidates with differentiated and potentially foundational characteristics,” said Dr. Dean Y. Li, president, Merck Research Laboratories, in the press release. “Pandion has applied its TALON technology to develop a robust pipeline of candidates designed to re-balance the immune response with potential applications across a wide array of autoimmune diseases.”

“Pandion grew out of our founders’ personal and scientific mission to change the way patients living with autoimmune diseases are treated. In just a few years, we have taken that mission from idea to clinical proof of mechanism with PT101, our lead IL-2 mutein. We are proud that Merck has recognized our team’s innovation and drive in creating a pipeline of diverse candidates that activate natural immune regulatory mechanisms and thereby have the potential to achieve better clinical responses for patients,” added Dr. Rahul Kakkar, CEO, Pandion Therapeutics, in the press release. “We believe Merck is well positioned to bring our novel approach to the millions of those living with autoimmune diseases, and we look forward to seeing these molecules progress in the clinic.”

Through the acquisition, Merck will have access to Pandion’s pipeline of precision immune modulators targeting critical immune control nodes, including its lead candidate, PT101.

Merck to Acquire Pandion Therapeutics for $1.85 Billion

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has started a rolling review of regdanvimab (CT-P59), which is a monoclonal antibody being developed by Celltrion for the treatment of COVID-19.

EMA revealed in a Feb. 24, 2021 press release, that the decision to start the rolling review of regdanvimab has been based on preliminary results from an ongoing study assessing the therapy’s ability to treat COVID-19. However, the full data set has not yet been evaluated and the regulatory agency stressed that it is too early to draw any conclusions regarding the benefit-risk balance of the medicine.

The first batch of data, which has been obtained via animal studies and clinical trials, are currently being evaluated by EMA along with any data relating to the quality of the medicine. All data will be evaluated by EMA as they become available, with the rolling review continuing until sufficient evidence is available to support a formal marketing authorization application.

EMA's CHMP has started a rolling review of regdanvimab (CT-P59), which is a monoclonal antibody being developed by Celltrion for the treatment of COVID-19.