Routine testing revealed differences in the hyaluronidase plate assay were directly related to the source hyaluronic acid used to prepared the plates. Evaluation of a synthetic hyaluronic acid, available at a approximately one-half of the cost of naturally occurring hyaluronic acid was initiated. testing of four lots of the synthetic materials, grouped by molecular weight range, produced more consistent results in assay of the venoms. The use of the synthetic material also avoids concern related to the transmission of viruses from the human origin hyaluronic acid. CBER plans to introduce the procedure describing the alternative substrate at the manufacturer's meeting in October.
