When it comes to biologics, "the product is the process." Since the finished product cannot be fully characterized in the laboratory, manufacturers must ensure product consistency, quality, and purity by ensuring that the manufacturing process remains substantially the same over time.
As we move (albeit cautiously) into the era of biosimilars, one of the hoped-for advances is in manufacturing. Saying that such technologies are complicated is an understatement.
To achieve real success towards “better, faster, cheaper,” it is in the best interests of the public health for process mavens to work closely with the FDA to determine how new technologies can be expeditiously incorporated into biologics manufacturing standards.
Perhaps its time for the time for the FDA to create an advisory committee on biologics manufacturing standards and practices.