ARTICLES BY TRISHA GLADD
FDA News Round-Up: Novartis, Bristol-Myers, Jazz, And More
What FDA news did you miss for the week of September 28th to October 2nd?
BPI 2015 Looks To The Future Of Biomanufacturing
The future of biomanufacturing focuses on a simpler, cheaper, and more efficient way to make medicine. See how the BioProcess International (BPI) Conference intends to help drive the industry toward this goal.
Can The FDA Support Biomedical Innovation? New Report Shows Doubt
In 2007, an advisory board to the FDA Commissioner was tasked with assessing whether or not the FDA is equipped to support current and future regulatory needs as they relate to medicine and food. At that time, the committee concluded the FDA did not have the scientific foundation necessary to meet its regulatory responsibilities. A subcommittee released an updated report last week. Eight years later, doubt still remains.
What Do You Need To Know About Tech Transfers For Autologous Cell Therapy Products?
Because of the sensitivity of donor cells, completing tech transfers for cell therapy products can be especially challenging. Ali Siahpush, president of Pharmefex Consulting, discusses the challenges of this task, particularly when acquiring them from academia, as this remains a major source of innovation in this area.
“Stupid Money” Arrives In Cell Therapy: Can It Be Sustained?
Anthony Davies, president of Dark Horse Consulting, says recent mergers and acquisitions, as well as other significant investments, seem to indicate that there is no immediate limit to the capital influx that is occurring in the cell therapy market. He refers to this influx as “stupid money.” But can it be sustained?
International Organization Joining Pharma And Academia Brings Opportunity To Boston
Experts in pharma do not always seek out academic partners beyond the walls of an innovation center or industry conference, but these interactions are crucial to the future of drug development. By taking advantage of the this organization's reach within academia, pharmaceutical companies have access to untapped potential in a talent pool that includes brilliant minds from all over the world.
Building Cancer Assassins: Kite Pharma Talks CAR T-Cell Therapy
Improvements in molecular biology and the understanding of immunology have generated compelling results in recent clinical trials for CAR T-cell therapies. As a result, interest in this area has increased tremendously. I recently spoke with Dr. Marc Better, VP of product sciences at Kite Pharma, about what challenges and opportunities await any company entering this growing market.
Scale-Up Of Autologous Cell Therapies Realized Through Technological Collaboration
The autologous cell therapy market is experiencing tremendous growth, but under the current system for manufacturing these products, companies struggle to get a return on their investments. However, a recent partnership between Octane and Lonza may finally offer a cost-effective solution to scale-up that could give companies new hope for commercialization.
How Can You Mitigate The Risks Of Single-Use Bags?
The loss of product as a result of bag failure isn’t just an annoyance; it’s an expense, and a costly one at that. However, Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, says with proper fitting and handling, these concerns can be mitigated.
Making The Switch To Single-Use: Have You Thought Of Everything?
In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.