Wednesday, February 1, 2023 Daily Archives

Rapid and Efficient Measurement of Critical Quality Attributes and Parameters Using Octet® Bio-Layer Interferometry (BLI) Systems

Critical quality attributes (CQAs) are defined as a physical, chemical, biological, or microbiological property or characteristics that should be within an appropriate limit, range, or distribution to ensure the desired product quality. These essential measurements include product-specific attributes such as size, charge, and glycosylation patterns as well as process-related impurities including host cell proteins and residual Protein A from chromatographic purification. CQAs must be identified early in the discovery process, reflect the target product profile of the drug candidate, and…

Amgen US Humira biosimilar arrives five months ahead of the pack

Amgen has launched Amjevita with a two-tier list price strategy offering the biosimilar at discounts of 55% and 5% over AbbVie’s Humira (adalimumab). After 20 years and over $200 billion of sales, AbbVie’s anti-TNF-α monoclonal antibody Humira is facing competition in the US with the launch of Amjevita. “Today, we announced the launch of Amjevita, the first US biosimilar to Humira, a medicine used by more than 1 million patients living with serious inflammatory diseases,” Amgen’s EVP of Global Commercial…

Sanofi to cut hundreds of jobs at two India vaccine plants

Sanofi plans to let go of all its employees at its manufacturing facilities near Hyderbad, following an operations review. According to Reuters, the decision for French drug maker Sanofi to let go of all employees at its two Indian vaccine plants follows the firm’s failure to win a UNICEF contract. The article outlined around 800 members of staff could be affected by the decision and said the Sanofi sources are not being named due to confidentiality. “Over the last few…