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.
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.
Advanced Drug Delivery Systems Market, valued at USD 234.84 billion in 2023, is on a trajectory of significant growth, projected to reach USD 352.01 billion by 2032
The U.S. Food and Drug Administration on January 15, 2025, announced its decision to ban Red Dye No. 3 also referred to as Erythrosine.
Targeted drug delivery revolutionises treatment by focusing medications on specific tissues, reducing the impact on healthy cells. Scientists enhance this precision with carriers like microspheres and nanoparticles, controlling release and absorption. Microspheres, made from biodegradable proteins or polymers, sustain drug release, making them ideal for targeted therapies, especially in oncology. Beyond drug delivery, microspheres open new possibilities across industries—from next-gen coatings to thermal insulation. With tailored sizes, shapes, and materials, they drive advancements in pharmaceuticals, advanced materials, and more.