BETTER GUIDELINES NEEDED
As previously discussed, most protein-based therapeutics are administered parenterally and oral standards aren't appropriate
for excipients used in their manufacture. In spite of this situation, stabilizing excipients manufactured according to API
standards are not yet mandated. Although such products have recently become available, formulators are often hesitant to incorporate
such new materials not specified in regulatory guidelines; the need for regulatory compliance tends to lock in use of existing
ingredients. As growing numbers of new drugs in development are protein-based, it is critical that regulatory guidelines be
updated to clarify the situation for manufacturers and reduce risk to their products and patients.
Table 1c. Manufacturing procedures required for active pharmaceutical ingredients and intermediates according to Q7A.10
Tom Biere is director of quality assurance and regulatory affairs at Ferro Pfanstiehl Laboratories, Inc., 1219 Glen Rock Avenue, Waukegan, IL 60085, tel 800.383.0126, fax 847.623.9173
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