CMOs are positioned to play a leading role in standardizing control strategies for gene therapy because so many gene therapy products are funneled through CMOs for commercial scale production.
A number of challenges are hindering efforts to develop cell and gene therapies to treat rare diseases. While these challenges may seem common across other drug markets, in the case of rare diseases, they are exacerbated by limited patient populations
Single use technologies are expected to play a big role in the commercialization of cell and gene therapies because of their cost, speed, and sterility benefits.
Solving the bottleneck in gene therapy of manufacturing of viral material at sufficient cost and scale.
Testing for evidence of microbial contamination in bioprocessing has a long history — and can be expensive, slow, and burdensome. So suppliers, testing facilities, and regulators have been seeking improvements.
A look at three scenarios that may impact the decision of virtual or in-house manufacturing, as well as key aspects to consider in the selection process and in forming a strong relationship between the company and CDMO.
With the FDA’s approval of three new gene therapies, researchers and manufacturers must now figure out how streamline the development process.
Opportunities related to the world’s third largest pharma industry tend to get drowned out by U.S. domestic events, and news from Europe, China, and even India. But if you haven’t been, it’s time to start paying attention to Japan again. There are opportunities for partnering, providing services to Japan Pharma, and for market penetration by foreign biopharma companies.
The story of how Oxford BioMedica won a key contract from Novartis to provide the commercial and clinical supply of lentiviral vectors used to produce the Big Pharma's CAR-T cell therapy Kymriah.
An inside look into how this fledgling biopharma has raised over $150 million and enlisted two high-profile CEOs from one of the hottest VC firms around, all in less than two years.