With breakthroughs in molecular engineering and antibody humanization, monoclonal antibodies (mAbs) are one of the fastest-growing classes of biopharmaceuticals for most clinical indications. In 2017, 10 therapeutic monoclonal antibodies were approved in the EU or US with nine additional candidates under regulatory review and 60 in phase III clinical trials 1. mAbs are the backbone of many treatment modalities including unconjugated therapeutic antibodies, antibody drug conjugates, bispecific antibodies and CAR-T cell therapy. Many of the approved antibody drugs engage the…
Monday, August 26, 2019 Daily Archives
Bavarian Nordic looks to go big on back of smallpox vaccine
Smallpox vaccine developer Bavarian Nordic says it will expand its infectious disease and cancer pipeline and grow its manufacturing network, possibly through M&A. Danish vaccine maker Bavarian Nordic laid out its growth vision during it second quarter 2019 financial call, and said it hopes to be a leading and profitable biotech company by 2023. To do this, the firm will look to its smallpox vaccine business as a starting point. Bavarian Nordic has a long-term contract for the manufacturing and…
Think your CMO is high maintenance? Let’s hope so
Having a well-managed facility maintenance schedule can avoid lengthy shutdowns and lost revenues, says a regulatory expert. During the Q2 2019 reporting season, Samsung BioLogics reported revenues of KRW 78.1 billion ($65 million) compared to KRQ 15.1 billion recorded in the previous quarter. The Korean contract manufacturing organization (CMO) attributed the 38% drop to the plant operation rate temporarily decreasing at its 152,000 L plant number 2 during the quarter due to “regular maintenance essential for biopharmaceutical manufacturing.†According to…