vaccines Archives - Medical Design Sourcing

5 key steps for building a secure cold chain to maintain vaccine and therapeutic stability

Cold chain image courtesy of Thermo Fisher Scientific

COVID-19 vaccine development and rollout were crucial to gaining control of the pandemic. When the success of these efforts became dependent on the ability to maintain lower than typical temperatures during distribution, the importance of reliable and continuous cold chain solutions for mRNA-based formulations was thrust into the spotlight. Beyond pandemic mitigation measures and outside of COVID-19 control, vaccines and therapeutics are increasingly leveraging the power of temperature-sensitive cells, proteins, and nucleic acids in preventing and treating disease. With the pharmaceutical industry shifting toward using biological molecules as medicine, there’s a need to emphasize cold chain logistics and access to innovative, reliable cryogenic solutions.

Pharmaceutical products containing biologically active components often require adherence to special …

Sanofi details €2B plan to make France an mRNA leader

French drugmaker Sanofi (Nasdaq:SNY) said it would spend €935 million between 2022 and 2026 to produce mRNA-based vaccines.

That funding is part of a larger €2 billion initiative to accelerate its mRNA development capability, Sanofi explained on its French-language website.

The company plans to use the funds to ramp up its lipid nanoparticle production capability and identify six candidate mRNA vaccines.

To commemorate the investment, French Prime Minister Jean Castex and Sanofi CEO Paul Hudson arrived at the company’s planned Evolutive Vaccines Facility plant in Neuville, France, on March 7.

The Neuville site will ultimately house equipment for multiple vaccine and biological platforms.

To date, Sanofi has been left on the sidelines as Pfizer (NYSE:PFE), BioNTech (Nasdaq:BNTX) and Moderna (Nasdaq:MRNA) have raked in billions of dollars of mRNA-based vaccine sales.

Last year, Pfizer raked in $36.8 billion in COVID-19 vaccine sales al…

Q-VANT aims to rewrite the narrative for Quillaja saponin-based adjuvants

Demand is heating up for Quillaja saponin-based adjuvants, which owe their existence to the soap bark tree (Quillaja saponaria) found primarily in Chile.

In particular, the QS-21 saponin adjuvant is popular. It is found in GSK’s (NYSE:GSK) Shingrix shingles vaccine, GSK’s Mosquirix malaria vaccine and Novavax’s (NSDQ:NVAX) COVID-19 vaccine. QS-21 is uniquely capable of enhancing the immune response to vaccine antigens.

Clinicaltrials.gov sites 55 studies using the adjuvant. Novavax alone aims to produce 2 billion vaccine doses annually.

Rising demand for saponin-based adjuvants threatens to exhaust supply, but the company Q-VANT Biosciences (Sagamore, Massachusetts) has emerged from stealth mode, boasting that it can increase the production volume of QS-21 by more than 1,000 times over traditional methods.

Image courtesy of Q-VANT

“We are rewriting that whole narrative,” said Q-VANT CEO …

Biotecnica introduces new line of peptones

Image courtesy of Biotecnica

Peptone manufacturer Biotecnica (San Jacinto Amilpas, Mexico) is debuting a new line of low endotoxin peptones that do not need ultrafiltration.

The company created the EndoLow-branded peptones for use in the production of a variety of drugs, including vaccines and diagnostic products.

Offering high levels of nitrogen, vitamins and carbohydrates, peptones have ideal properties for cell cultures.

The Swiss botanist Carl Nägeli described peptones in 1880, which can be created by partially hydrolyzing proteins with acids, bases or proteolytic enzymes.

The EndoLow peptone line offers high levels of amino acids, polypeptides and carbohydrates while offering minimal endotoxin levels.

The line is available in three types, based on casein, bovine tissue and soy, respectively.

Biotecnica uses a Limulus amebocyte lysate (LAL) test to determine endotoxin l…

Functional single-cell proteomics firm Isoplexis misses IPO target

Branford, Connecticut–based Isoplexis (NSDQ:ISO) made its public market debut today with an initial public offering of 8,333,000 shares of common stock initially priced at $15 per share.

ISO shares ended up selling for $11.52 apiece at the end of trading, equating to $96 million (less fees and expenses associated with the IPO). That was 23% less than its $15-per-share target, which would have raised $125 million before fees and expenses.

“We can’t control how the stock trades every day, but we can control being good at our jobs and producing revenue and growing the company,” Isoplexis co-founder and CEO Sean MacKay told Drug Discovery Trends.

The company plans to use proceeds from the IPO to invest in commercial expansion and hiring new staff.

“We grew about 103% in the first half of this year,” MacKay said. “To continue to move worldwide with our product, we need to continue to invest in the commercial teams.”

Isoplexis also plans to expan…

Could COVID-19 vaccines guard against dementia?

COVID-19 vaccines could potentially guard against dementia and Alzheimer’s disease, according to an op-ed in WSJ.

COVID-19 infection itself can lead to long-term cognitive decline in some individuals and can accelerate Alzheimer’s symptoms, concluded an Alzheimer’s Association study. An Alzheimer’s Research & Therapy echoed those findings.

Pointing to data suggesting that vaccinations against tetanus and flu lead to reduced Alzheimer’s incidence in seniors, the WSJ article notes that a systemic immune response from vaccines could lower brain inflammation and thus protect brain neurons.

The thesis is not new. For example, a 2001 study in the Canadian Medical Association Journal theorized that prior vaccination against diphtheria or tetanus, poliomyelitis and influenza could protect against Alzheimer’s disease.

And last July, the Alzheimer’s Association published a study making similar claims. Researchers have correlated flu and pneumonia vac…

Report: Two vaccine leaders set to step down from FDA

Two senior vaccine leaders within the FDA are reportedly relinquishing their positions within the administration.

According to a report from Endpoints News, which cites a letter released internally to FDA staff first reported on by BioCentury, Marion Gruber and Phil Krause will depart in the coming months due to frustrations over the delegation of certain decisions within some governing bodies. All this comes amid a critical juncture in the effort to vaccinate the U.S. against COVID-19, with the FDA recently fully authorizing Pfizer and BioNTech’s vaccine and reviewing booster shots, which could be available in September.

Gruber, a 32-year veteran at the FDA and currently the director of the FDA’s Office of Vaccines Research & Review, will leave at the end of October, the report said. Krause, the deputy director of the Office of Vaccines Research & Review, will leave in November.

Endpoints cited a former FDA leader as saying Gruber an…

Overcoming vaccine delivery device design’s top challenges

[Photo by Eugene Chystiakov]

Vaccine delivery has long been a hot topic and only got hotter in the ongoing push to vaccinate against COVID-19 around the world.

Most would probably associate vaccines with the standard “jab” injection with a syringe. Over the past year and more, companies have touted ideas for other avenues. Inovio has a “smart” delivery device for a COVID-19 vaccine, while Intravacc is developing a nasal COVID-19 vaccine, plus there are many more in between.

Whether it’s standard delivery devices or the innovative ones various companies are trying to bring to the market, there are difficulties in creating the vessels for the potentially life-saving therapeutics they deliver.

Drug Delivery Business News spoke with Scott Thielman — chief technology officer at Product Creation Studio, a company that offers insights to deliver designs for a range of entities, including medical device comp…

Sanofi reshapes mRNA landscape with $3.2B Translate Bio buy

Sanofi (NSDQ:SNY) may be one of the biggest vaccine manufacturers in the world, but the quick rise of the mRNA vaccine platform during the pandemic caught the company by surprise.

The company could be on the way to rectify that with its $3.2 billion acquisition of its mRNA partner Translate Bio.

Sanofi began working with Lexington, Mass.–based Translate Bio in 2018 and expanded that partnership last June with a $2 billion collaboration.

In the most recent deal, Sanofi will pay $38 per share for Translate Bio’s shares.

Sanofi plans to use mRNA technology for various clinical uses beyond vaccines, including immunology, oncology and rare diseases.

The mRNA-based Moderna (NSDQ:MRNA) and Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) vaccines have generated tens of billions of dollars in sales in 2021. Pfizer anticipates the BNT162b2 vaccine could generate $33.5 billion in sales this year. Moderna’s market valuation hit $140 billion on Aug. 2, while B…

Pfizer highlights COVID-19 and flu vaccine strategy in Q2 earnings call

With vaccines generating a significant portion of Pfizer’s (NYSE:PFE) revenue in the first six months of 2021, the company shed light on its vaccine plans in its most recent quarterly earnings call.

While the company recently won FDA approval for its potential blockbuster pneumococcal 20-valent vaccine, its mRNA vaccine strategy understandably took center stage during the Q2 call yesterday.

Get the full story from our sister site, Drug Discovery Trends.

An inside look at GSK’s digital twin initiative

A GSK vaccine facility. Image courtesy of GSK.

Digital twins, functional computerized models of physical objects, are a staple of smart manufacturing. Their use in the pharmaceutical industry, however, is still in an early phase.

GlaxoSmithKline (LON:GSK) is one of the first pharmaceutical companies to announce a digital twin initiative. Partnering with Siemens (ETR:SIE) and Atos (EPA:ATO), GSK has created a real-time simulation of the entire vaccine manufacturing process.

A year in the making

The project, which launched a year ago, has already shown promise in reducing manufacturing timelines, optimizing product quality and other areas. The use of digital twins has enabled GSK to optimize vaccine-related experiments. “With digital twins, you’re able to do huge amounts of digital experiments and minimize the number of wet experiments that you do,” said Matt Harrison, head of sciences, digital innovati…

FDA releases scathing inspection report regarding Emergent BioSolutions plant

An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca.

The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch.

Emergent BioSolutions recently paused production of the vaccine during the FDA inspection and had quarantined doses it had in reserve. The FDA will subject those vaccines to further testing before clearing the way for their distribution, explained two head FDA officials, Peter Marks and Janet Woodcock, in a statement.

It is possible that other batches of vaccine need to be discarded. “There is no assurance that other batches have not been subject to cross-contamination,” the FDA concluded.

“The issuance of findings by the FDA is normal following a facility inspection and provides direction on the necessary steps to improve operations. Emergent is committed to workin…