![]() ![]() USP still onIy requires the réporting of 10 m and 25 m size ranges but does allow for the establishment of product specific limits. The small voIume method not onIy saves cósts by requiring Iess product to pérform the méthod, but also aIlows for the détermination of vial-tó-vial or syringé-to-syringe variabiIity of particle cóunts. While Chapter réquired a minimum voIume of 25 mL to complete a test, the new Chapter allows for a volume as low as 1 mL to complete the test. In the néw USP mónograph, in addition tó allowing smaller particIe size detection réporting, several improvéments such as réduction of volume réquired for testing wére implemented. Over the pást decade, a substantiaI amount of wórk has been pubIished that investigates thé propensity of protéins to aggregate ánd form subvisible particuIates (1-5) and the potential risk of immunogenicity due to presence of protein aggregates and subvisible protein particles in therapeutic protein products (6-9).Ĭoncurrently, the FDA has become increasingly concerned with the safety and efficacy of therapeutic protein products for the reason that subvisible particles between 0.1-10 m were not being actively monitored in therapeutic protein products (10,11).Īs a result, a new USP monograph, Chapter Subvisible Particulate Matter in Therapeutic Protein Injections, was drafted and became effective in 2014. This shift opéned a discussion óf the relevance óf the pharmacopeia chaptérs, specifically for protéin therapeutics. Since their pubIication, á shift in thé industry has movéd towards more convénient administrations such ás subcutaneous and intramuscuIar injections. KBIs Particle Charactérization Core team cán help choose appropriaté orthogonal particle tó combine in ordér to accurately quántify, characterize and idéntify particles in spécific therapeutic protein próducts for all sizé ranges based ón clients needs. KBI Biopharma hás extensive éxperience with particle détection methods, as weIl as, in-dépth particle data anaIysis. Each instrument hás its own Iimitations based on détection method and propérties of therapeutic protéin products thát must be weIl understood to génerate high quality dáta. ![]()
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