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.
Donald Trump’s tariffs of 50% have come into force on most US imports from India. India’s giant generic pharmaceuticals sector and its electronics and petroleum products are exempt from the tariffs. Aluminium, steel and copper remain at 25%, but job-heavy sectors such as textiles, jewellery, seafood and leather are squarely in the line of fire.
The European Chemicals Agency (ECHA) has published the updated proposal to restrict per- and polyfluoroalkyl substances (PFAS) under the EU’s chemicals regulation, REACH. The update has been prepared by the authorities from Denmark, Germany, the Netherlands, Norway and Sweden, who submitted the initial proposal in January 2023.
Most chemicals exported from the 27 member countries of the European Union into the US will be subject to a 15% tariff on top of their selling prices under an agreement signed on July 27 between the US and the European Commission.
We’re thrilled to announce a new strategic alliance between ExSyn, Exim-Indis and simABs, a leading EU-based biologics manufacturer known for its patented continuous flow technology in antibody production.
The global trade landscape is undergoing significant changes following the announcement of new reciprocal tariffs by the United States government. Recent developments indicate significant shifts in global trade dynamics, with key policy adjustments, ongoing negotiations, and evolving logistics patterns. Below is a summary of the latest developments.
In January 2025, the US FDA published a draft regulatory guidance entitled “The Considerations for Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products”.
The adoption of artificial intelligence (AI) and large language models (LLMs) is rapidly reshaping clinical research and drug development.
In the quest for increased sustainability, a lot has been made of the potential to use bio-based raw materials, captured CO2 and recycled plastics as raw materials for new chemicals. But what about using biotech processes to manufacture chemicals? Could it offer a more sustainable alternative to traditional petrochemical processing, and be more amenable to biobased raw materials?
High duties on imports from Canada, Mexico and China raise problems for international supply chains.