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Recommendations Sourcing Human Biospecimens

The foundations for protecting human research subjects come from the ethical principles surrounding the Belmont report : Respect for persons, beneficence, and justice. The use of human biospecimens in research supports these principles with legal and ethical regulations - the most important of which is permission.(1) This permission may come directly from the donor or granted by others with authorization to protect the interests of biospecimen donors.
Recommendations Sourcing Human Biospecimens
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News and Press Releases

KITE’S CAR T-CELL THERAPY TECARTUS® (BREXUCABTAGENE AUTOLEUCEL) GRANTED EUROPEAN MARKETING AUTHORISATION FOR THE TREATMENT OF RELAPSED OR REFRACTORY ACUTE LYMPHOBLASTIC LEUKAEMIA (r/r ALL)

Stockley Park, UK – 7 September 2022 – Kite, a Gilead Company, today announced that the European Commission (EC) has approved its CAR T-cell therapy Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukaemia (ALL).
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White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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