Establishing Manufacturing Controls: A Hurdle for the Cell and Gene Therapy Industry
Mo Heidaran
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Mo Heidaran
Biotechnology professional, cell and gene therapy enthusiast, and founder of CHCF, a nonprofit organization dedicated to biomarker discovery and development for brain health.
Posted 25 April 2019 | By Mo Heidaran, PhD
Addressing manufacturing controls for the cell and gene therapy industry, this article discusses criticality of establishing Chemistry Manufacturing Controls (CMC) Readiness, Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) for cell and gene therapy products. The author suggests manufacturers need sound drug development and manufacturing facility plans covering a product’s lifecycle and should establish sustainable manufacturing control strategies for each product class. The author also identifies specific guidance and support materials from a number of governmental and commercial organizations to assist in developing products that can be approved by regulators.
Solu??es em Biofabrica??o e Engenharia de Tecidos | Co-fundador e CEO 3D Biotechnology Solutions - 3DBS l Bioimpress?o l Eletrofia??o l Organs on a Chip l In vitro models I Valida??o Biológica de processos Alimentos
5 年Very instructive and important, thank you
Empowering scientists to build biotech startups. Supporting large organizations in global innovation and expansion, with expertise in cell and gene therapy. DEI advocate and emotional intelligence champion
5 年Very good read. Thank you for sharing