Pharmaceutical Processing World Archives - Page 64 of 64

Merck eyes tiny patches as a vaccine delivery method

Vaxxas’ High Density Microarray Patches (HD-MAP)

Merck has exercised its option to use Vaxxas‘ High Density Microarray Patch (HD-MAP) platform as a delivery platform for a vaccine candidate, the companies announced today.

The companies did not disclose what the vaccine candidate is supposed to treat. But Merck this month announced two COVID-19 vaccine development efforts: a collaboration with IAVI and plans to acquire vaccine developer Themis Bioscience. Vaxxas (Cambridge, Mass.; Brisbane, Australia) notes that any vaccine could be delivered with its dime-sized patch.

Also today, Vaxxas announced that German manufacturing equipment maker Harro Höfliger will help Vaxxas develop a high-throughput, aseptic manufacturing line to make vaccine products based on Vaxxas’ HD-MAP technology — with a goal of eventually churning out millions of vaccine patches a week.

Get the full story on our …

Thermo Fischer Scientific to boost manufacturing for CSL

Thermo Fischer Scientific announced today that it has inked a strategic partnership with biotechnology company CSL to help better meet the growing demand for biologic therapies.

Thermo Fisher will support CSL’s product portfolio through its pharma services network, including drug product development, biologics manufacturing, sterile fill-finish, packaging and clinical trials logistics. Thermo Fisher — through a long-term lease agreement with CSL — will also operate a new state-of-the-art biologics manufacturing facility in Lengnau, Switzerland.

The companies expect the construction of the new facility in Switzerland to finish in mid-2021.

“We continue to invest to meet the growing need for flexible biologics capacity, and Lengnau will significantly expand our pharma services capacity and capabilities,” said Michel Lagarde, EVP of Thermo Fisher Scientific.

Within the Lengnau site, Thermo Fisher will support the manufacturing of C…

Siemens Healthineers to produce 50m antibody tests per month against COVID-19

Siemens Healthineers (ETR: SHL) said today that it has started worldwide shipments of its COVID-19 antibody test, with a goal of producing 50 million tests per month as the pandemic evolves.

The German medtech giant boasts that it has 20,000 systems worldwide to run the tests, including what it describes as the largest analyzer installed base in the U.S. Siemens Healthineers is increasing test production at its Walpole (Walpole, Mass.) and Glasgow (Newark, Del.) facilities so that it can exceed 50 million tests per month starting in June.

Get the full story on our sister site MassDevice.

Mass-producing a COVID-19 vaccine is going to be hard

[Photo by Fusion Medical Animation on Unsplash]

Creating a safe and effective COVID-19 vaccine is just the first step. Recent media reports suggest that making it will also be a major challenge.

There are presently a number of vaccine candidates around the world that are showing promise and entering the clinical studies phase — a speed of development usually unheard of in the vaccine space. The fact that there is more than one potential vaccine showing promise is good: Experts say the world will likely need more than one approved vaccine to effectively scale up production.

But some of the promising vaccine candidates from companies such as Inovio and Moderna use cutting edge technology that has never been scaled up to produce millions of vaccine doses in factories, according to a recent report in The New York Times.

In the U.S., the White House has created a private-public partnership called Ope…

Phlow lands $354m government contract for COVID-19 medications

Phlow announced today that it received $354 million in U.S. government funding to manufacture essential medicines at risk of shortage, including those involved in the COVID-19 pandemic response.

Richmond, Va.–based Phlow’s manufacturing is being funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Dept. of Health and Human Services (HHS).

The total contract awarded to Phlow by the government totals up to $812 million with a four-year base award of $354 million, plus an additional $458 million included as potential options for long-term stability, according to a news release.

“BARDA has long focused on expanding pharmaceutical manufacturing infrastructure in the United States, not only to develop and produce vaccines, but also for essential medicines, and their key ingredients used to make these drugs,” BARDA acting director, Dr. Gary Disbro…

ACG receives Clean Label Project certification for capsules

[Image courtesy of ACG]

ACG (Mumbai, India) announced today that the nonprofit Clean Label Project has certified its ACGcaps H+.

Clean Label Project certification signifies that a product has met strict and comprehensive testing to demonstrate a priority on purity and environmental sustainability, according to ACG. The nonprofit evaluates test results against California Proposition 65, which is meant to protect products from contaminants known to cause cancer, birth defects or other reproductive harm.

ACGcaps H+ capsules are suitable for filling granules, powders, pellets for prescription and non-prescription pharmaceutical ingredients, nutraceutical dietary supplements, and traditional medicines.

Gilead licenses remdesivir production to 5 generic drugmakers

Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19.

The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access, according to Foster City, Calif.-based Gilead.

Get the full story on our sister site, MassDevice.

Pfizer to outsource more production as it prepares for COVID-19 vaccine

Pfizer is turning to its 200-strong network of outside contractors to make more of its existing medicines as it prepares for a potential COVID-19 vaccine., according to media reports.

The New York–based pharmaceutical giant said May 5 that it will invest at-risk to produce millions of doses of a coronavirus vaccine in 2020, boosting production to hundreds of millions of doses in 2021. Pfizer sites in Massachusetts, Michigan, Missouri and Puurs, Belgium will serve as vaccine manufacturing centers — with more sites expected to be added to the list.

BioNTech — Pfizers’s partner in developing a COVID-19 vaccine — plans to ramp up production sites in Mainz and Idar-Oberstein, Germany,

The first participants in Pfizer and BioNTech’s Phase 1/2 clinical trial for the BNT162 vaccine program have already been dosed in Germany and the U.S.

“The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies …

India-led research effort asks the question: How do we keep a potential COVID-19 vaccine cold?

[Image courtesy of University of Birmingham]

U.K. scientists have joined a research effort in India to help solve distribution problems around whatever COVID-19 vaccine hopefully emerges from global efforts, according to a recent news release from the University of Birmingham.

Backed by the Shakti Sustainable Energy Foundation, experts from the University of Birmingham and Heriot-Watt University, Edinburgh are investigating the challenge involved in distributing a potentially temperature-sensitive COVID–19 vaccine.

The Centre for Environment Education (CEE) in India is leading the overall research, with support from commercial partners such as Zanotti (a part of the Daikin Group), Sure Chill and Nexleaf Analytics. The British researchers are exploring how integrated “Community Cooling Hubs’” can integrate food cold chains with other cold-dependent services such as community health fac…