Cell and Gene Therapy

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...
Features
The 2018 ISPE Biopharmaceutical Manufacturing Conference on 10–12 December in Huntington Beach, California, provided information about future-oriented developments in the burgeoning area of biopharmaceutical manufacturing—and also shared insights into the achievements that are already underway....
iSpeak Blog
There is a paradigm shift occurring in the biomanufacturing space around the advancement of personalized medicine that is creating new challenges for biomanufacturing facility design, both in terms of process technology and facility development...
Insights
Many spend their summer relaxing, perhaps traveling, but generally trying to “put their feet up.” Others change the course of health care as we know and practice it. Gilead’s 28 August purchase of Kite Pharma, one of the companies developing chimeric...
Features
On 30 August, the US Food and Drug Administration (FDA) approved Novartis's Kymriah (tisagenlecleucel, CTL019), the first gene therapy for the treatment of pediatric and young-adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). Kymriah belongs to a class of drugs...
Training
The complexity of the current industry structure has held back innovation , with many biomanufacturers trying to develop new technology in isolation, whilst industry supply partners often guess common industry...
Training
This online course is an introduction to the processes used to manufacture the therapeutic proteins from cells modified using recombinant DNA technology. It is an an online introduction to ISPE's Biomanufacturing...
iSpeak Blog
    Mihaela Simianu, PhD, Director of Regulatory Compliance, Pharmatech Associates, Inc., led an interactive session on Emerging Therapeutic Entities in Immunotherapy and Gene- and Cell-Based Therapies on 6 June 2017, day 2 of the 2017 ISPE/FDA/PQRI...