Lipids are an unsung component in the two mRNA-based shots, the only vaccines to be approved so far in the US. Naked mRNA quickly degrades in the body and can trigger an unwanted immune reaction. To get the genetic material to its target cells, vaccine developers combine it with a mixture of several sophisticated lipids to form lipid nanoparticles, or LNPs. mRNA vaccine producers use a package of 4 lipids to formulate their LNPs:
| An ionizable cationic lipid that encapsulates the negatively charged mRNA |
| PEGylated lipid that helps control particle life and size |
| Distearoylphosphatidylcholine (DSPC), a phospholipid that helps form the structure of the LNP |
| Cholesterol, which also contributes to structure |
While the biopharmaceutical companies struggle to respond to huge demand for their messenger RNA (mRNA) COVID-19 vaccines, suppliers of the specialty lipids needed to deliver the vaccines are scrambling to keep up the demand.
Very few companies in the world supply these custom lipids in significant quantities and to the standards needed for vaccine production.
To meet the high demand for lipids, a key component of mRNA-based vaccines and therapeutics, Merck, a leading science and technology company with their decades of experience in developing and manufacturing high quality lipids, has launched their new SAFC® synthetic cholesterol – a high purity synthetic product to market nine months ahead of schedule.
This neutral lipid, used in commercially marketed products, is more than 99 per cent pure; offers high batch-to-batch consistency and is scalable under commercial Good Manufacturing Practice (GMP). With the introduction of new SAFC synthetic cholesterol product, Merck has increased their capacity by 50 times, thereby augmenting biomanufacturers to bring life-saving therapies to patients.
As India is witnessing a rapid rise in the cases of Mucormycosis or black fungus, the demand for Liposomal Amphotericin B (LaMB) has surged. Lipids, one of the raw materials used to manufacture the LaMB, is in shortage. The demand for lipids has increased 10 times in past couple of months. The problem is further exacerbated as there are only limited manufacturers of the lipid globally. To meet this demand, Indian manufacturer’s specializing in Lecithins and Phospholipids too have now stepped up to increase its capacity for lipids by the end of 2021.
Given the evolving on-ground situation and newer variant-led infections, the pandemic is far from over. In such a scenario, for businesses to stay relevant, we will need to be flexible and more adaptable to the changes that need to be embraced to keep core business growth drivers resilient.
As the chemical industry moves into 2022, strong demand for both commodity and specialty chemicals should keep prices robust throughout the year. The industry could face margin pressures amid raw material cost inflation, which will likely remain high through the first half of 2022.
Blackouts and power cuts in the world’s second-largest economy have drawn attention to fuel supply problems that could complicate the country’s pandemic recovery.
The Federation of Indian Export Organizations (FIEO), an apex body of Indian export promotion organizations, has urged the government to provide freight support to all exports including pharmaceuticals till 31st March 2022, as freight rates have skyrocketed and are likely to somber by March 2022.
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In a landmark announcement, the World Health Organization (WHO) has recommended the use of the first-ever malaria vaccine for children. WHO Director-General Tedros Adhanom Ghebreyesus endorsed the RTS,S/AS01 malaria or Mosquirix – a vaccine developed by British drugmaker GlaxoSmithKline (GSK).
China’s power shortages hit growth in the world’s second-biggest economy, threatening more pain for global supply chains, while Europe’s gas squeeze looked set to continue as Russia’s Gazprom showed no sign of hiking exports to the region in October.
The fact that 22 such molecules are going to come out of their patent period will substantially expand the offerings of the Indian companies to people at home and abroad alike and may help fetch extra revenue.
“Current data indicates that neither food nor food packaging is a pathway for the spread of viruses causing respiratory illnesses, including SARS-CoV-2,” according to a new guidance document from the United Nations’ Food and Agriculture Organization (FAO): “In other words, SARS-CoV-2 is not a direct food safety concern.”