Recent trends in cell substrate considerations for continuous cell lines -Commentary

Product development activity in the past five to ten years has reconstitute d a version of an old debate on the safety assessment of biological product s, namely whether the use of some types of continuous cell lines (CCLs) is appropriate in the preparation of some types of biological products. Since 1987, dozens of purified recombinant DNA products derived from CCLs have be en developed and have received regulatory approval. In addition, several li ve attenuated and inactivated viral vaccines manufactured in CCLs were appr oved after thorough review of product safety and manufacturing issues. The current discussion revolves around the potential use of CCLs (human or not) to prepare purified protein subunit vaccines, such as for HIV, and the use of human CCLs to prepare purified protein products.