Cell Therapies

Quality Assessment in 3D Cultures of Disc-Chondrocytes

Autologous chondrocyte transplantation is a modern experimental therapy for treatment of degenerative intervertebral disc diseases. Several studies with animal models have shown that transplantation of cultivated autologous chondrocytes can delay progression of disc degeneration. A few products based on human autologous chondrocytes are already on the market. Repair of disc damages with grafted chondrocytes appears feasible in the near future. So chances are growing for clinical applications meant for restoration of original disc function. As a result, optimization and standardization…

Manufacturing Patient-Specific Cell Therapy Products

Several cellular therapies are currently progressing through clinical development with the potential to address unmet medical needs affecting millions of patients. As cell-based therapeutics receive regulatory approval and reach the market, the primary challenge will quickly become manufacturing such products in sufficient volume to meet demand. Aastrom Biosciences has developed tissue-repair cell (TRC) technology for use in autologous, patient-specific cellular therapy (PSCT) and is conducting late-stage clinical trials both in the United States and Europe. TRCs are derived from a…

Delivery Technology Reenergizes DNA Drug Development

In vivo delivery of DNA-based biopharmaceutical agents encoding proteins of interest (“DNA drugs”) offers a means for the production of protein by target regions of tissue in a subject. This product class derives activity from an ability to induce sustained endogenous protein expression from recipients’ own cells. These unique characteristics are favorable for multiple applications, several of which are now in clinical testing. Therapeutic Proteins: DNA drugs encoding autologous therapeutic proteins could serve as an alternative to long-term therapy based…

Sharing Is What It’s All About

Recently in Washington, DC, two conferences were held on the topics of cell and gene therapy. The California Separation Science Society (CASSS, www.casss.org) hosted a Well-Characterized Biological Products (WCBP) Chemicals, Materials, and Controls (CMC) strategy forum on “Current Practices for Assessing the Comparability and Stability of Gene Therapy Products,” while blocks away, Phacilitate hosted the 2008 Cell and Gene Therapy forum. At the WCBP CMC strategy forum, participants heard the US FDA–CBER perspective on the importance of comparability studies for…

In the Therapeutics Zone

Small molecules are still not providing cures for many diseases, and this is why biological therapies continue to be developed. They often offer greater convenience to patients, as well as longer lasting therapies,” says William Prather, MD, senior vice president of corporate development at the Israeli stem cell company, Pluristem. The therapeutics area at this year’s BIO International Convention will play host to many interesting technologies for producing and improving protein therapeutics, vaccines, and stem cells. Protein Therapies Remain Top…