1. Biosimilars belong to a group of medicine called biologics. Unlike common medicines, which are made from chemicals, biologics are made using cells or living organisms. Biosimilars have greatly improved trea
Much of it has to do with the type of drug that Humira is—a “biologic.” Unlike chemically synthesized drugs, biologics derive from actual biological material, making them significantly more complex than standard chemical medicines. And therein lies the key to AbbVie’s IP strategy, explains ...
Of note, all cell-free orthobiologics as well as all ortho- biologics that are based on allogeneic cells can in princi- ple only address the former, because differentiated cells derived from allogeneic stem cells are recognized by the immune system of the host organism and removed [48]. ...
The contract and manufacturing organization (CMO) industry can be segmented along obvious lines such as API versus drug product manufacturers, biologics versus small molecule, dose form(s) manufactured, and geographic focus. But none of these designations reflect the strategies that each CMO is pursu...
In the nineteenth century, significant strides were made in the field of medicine, but women still faced discrimination and barriers to practicing medicine. Despite this, some women were able to make notable contributions to the field. For example, Elizabeth Blackwell became the first woman to earn...
Official Chile data from 2023 say there are 98.000 RA, 21000 SLE and more than 4000 JIA patients. The health insurance covers only these 3 rheumatic diseases. Since 2015 certain biologics are reimbursed. IPARE is made up of members from Panama, the United States, South Africa, Ghana and ...
Some CDMOs specialise in certain areas, such as small molecule development, biologics development, or sterile injectables. CDMOs can also offer specialised services, such as gene therapy manufacturing. Overall, CDMOs offer a comprehensive range of services to help pharmaceutical and biotech companies ...
One such application lies in quality control for biologics manufacturing. “Whether you’re developing an mRNA vaccine or a gene therapy, you’ll need to confirm that the construct you’re using and its transcribed products are made as you intended,” says Thermo Fisher application scientist Claud...
When people are infected with a new virus, it can take two weeks for the body to produce enough antibodies to fight it off. Injecting people with antibodies made by cells growing in a vat can keep viruses in check until a person’s immune response kicks in fully. ...
There is also information about USP’s approach to biologics standards (9) and on their pending monograph process (10), which allows for development of monographs for articles awaiting approval by FDA. Supplementary Chapter III in the British Pharmacopoeia (BP) provides their requirements for ...