Cell & Gene Therapy

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Cell and gene therapies are complex. As more therapies come to market in the hope of bringing advanced treatments and cures to rare, orphan, and difficult-to-treat diseases, designing quality standards for these personalized medicines is equally as complex.European Commission. EudraLex, Volume 4:...
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30 Presentations Featuring 11+ Hours of Content No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference presentations from 2020, hand-selected the absolute best and brightest...
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In many critical ways, the design of facilities for multiple cell therapy processes is unlike the design of conventional pharmaceutical facilities. This article surveys several of the key issues to consider when designing facilities capable of manufacturing multiple cell therapies, including...
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Designing new facilities for cell and gene therapy manufacturing is a challenging task given the many uncertainties in this industry sector, including varying potential demand for any given new therapy, evolving platforms and technology, questions about equipment reliability, learning curves for...
iSpeak Blog
The spectrum of gene therapy with some specificity to viral vectors is very broad including both delivery vehicles developed for transient short-term and permanent long-term expression. Moreover, the types of vectors are represented by both RNA and DNA...
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Presenters and a panel of FDA regulators and industry experts discussed key regulatory and industry issues during the closing plenary of the 2019 ISPE Biopharmaceutical Manufacturing Conference.
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Innovations in production methods and technologies that enable a competitive and sustainable biopharmaceutical product supply were the focus of presentations at the 2019 ISPE Biopharmaceutical Manufacturing Conference in Boston, Massachusetts, 18–20 June. Future directions for the biopharma...
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Cell and gene therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce cells and genes into a patient to treat the underlying cause of a disease—they are living medicines.
iSpeak Blog
Solano Community College Hosts Advisory Panel to Honor First Graduating Class On 22 April 2019, more than 40 professionals and students attended the ISPE- Solano Community Advisory Panel at Solano Community College. This event was held in honor of the...
iSpeak Blog
“The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug applications. Based on this activity, we anticipate that the number of product approvals...