Manufacturing and quality assessment of allergenic extracts for immunotherapy: state of the art.

PURPOSE OF REVIEW: The recent developments in the manufacturing and quality assessment of allergenic extracts in Europe are summarized. RECENT
FINDINGS: Quality assessment has always been a fundamental part of allergen product evaluation. New analytical methods have been reported that fill currently existing gaps in the characterization of commonly used allergen products. New types of products require innovative considerations and concepts for their assessment. Advanced standardization efforts aim at increasing reliability and comparability of analytical tools applied for allergen product characterization. In consequence, regulatory requirements are updated in line with such developments.
SUMMARY: Current demands on the quality of allergen products ensure production of well characterized products of consistent quality. While experience with manufacturing processes and successful product characterization approaches increase, accompanying and continuous re-evaluation of underlying quality control and assessment concepts is being performed.