Freezing drug substances to ultra-cold temperatures is a standard step in biopharmaceutical manufacturing. Yet, beyond simply cooling, it’s the critical quality attributes (CQA), like product safety, consistency, and process efficiency, that trul...
ADC technology is a promising and exciting new approach in cancer treatment, selectively targeting a specific cell surface receptor expressed on cancer cells. With oncology being a main field of application, a number of preclinical tests for treat...
The safe handling of ADCs or other HPAPIs is a complex and elaborate process that requires specialized facilities and a safe, sterile environment. The filling/aliquoting step in particular calls for great care and specific equipment to ensure ster...
Antibody drug conjugates (ADCs) are a rapidly growing field of interest in biopharmaceutics. In comparison to conventional chemotherapy treatments, ADCs have the potential to destroy cancerous cells without damaging healthy cells in the process. T...
You may have come across the term “autologous” before in the context of stem cell therapy. Autologous stem cell transplantation is a type of cellular therapy that uses the patient's own stem cells to treat various types of blood cancers such as le...
Bioconjugation has become a common method to link small molecular fragments with special properties with much larger and more complex biomolecules like proteins, antibodies, nucleic acids and even cells. The two most important reasons to do this a...
Allogeneic cell therapy is a type of stem cell therapy that uses stem cells from a donor to treat a recipient. When it comes to treating various medical conditions, including blood disorders and cancer, the field of regenerative medicine has intro...
Bioconjugates have been used to develop a range of novel therapeutics, including antibody-drug conjugates (ADCs), which have shown great potential in cancer therapy. The manufacturing of bioconjugates is a complex process that involves linking a d...
Antibody drug conjugates (ADCs) are a class of therapeutics that combine the specificity of monoclonal antibodies with the potency of cytotoxic drugs. Since the first ADCs entered clinical trials in the 1990s, they have shown great promise in trea...
Microbial fermentation is a biochemical process that manages to extract chemical energy from carbohydrates without the oxygen. This chemical reaction occurs in bacteria, yeasts or even in muscles of humans. More than ten thousand years ago, humans...
Valuable bulk biopharmaceutical intermediates, such as bacterial or yeast cells in microbial fermentation or other intermediates produced during the manufacturing process of biopharmaceutical drugs, are often transported between different manufact...
Automated bioprocessing brings several advantages for the biopharmaceutical industry. Bioprocessing in general involves the use of living cells to produce drugs, vaccines, and other biologics. The biomanufacturing process is complex and requires p...
Drug substance vs. drug product: the difference might not be clear for people that are not trained in the fields of life sciences, chemistry or pharmaceutical sciences. While the term “drug substance” is limited to the active pharmaceutical ing...
