Fraudulent companies promising false cures for patients are a black eye for the pharmaceutical industry. For that reason, many companies are applauding the FDA’s recent crackdown on stem cell clinics that tout treatments with no data to back up their claims. One of those companies is Cynata Therapeutics.
White Paper |
By Mats Lundgren,GE Healthcare Life Sciences
To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
By Natalie O’Donnell and Justin Wilson,United BioSource LLC (UBC)
During the 12th annual REMS Summit in Virginia, UBC’s Natalie O’Donnell, corporate vice president, safety, REMS, and strategic engagement, and Justin Wilson, director, software development and technology, presented a session on the impact technology has had on REMS and the potential effect it can have in the future.
Widespread use of immune checkpoint therapy to treat cancers is hampered by unpredictable response rates and immune-related adverse events. To address these challenges, combination therapies are increasingly being studied as a strategy for improving response and overcoming resistance.
Process development is a critical enabler to bring safe, effective, sustainable products to market to address patient needs. In this webinar we will discuss our strategies for developing lentivirus and adeno associated virus (AAV) and the impact these early decisions can have on commercial readiness.