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. In some ways, will cell and gene therapy manufacturing be similar to biopharmaceutical manufacturing? What are the key differences and gaps in learning?
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.
As the gene and cell therapy sector develops and its products start to move from development to commercial manufacture — from smaller or academic establishments and development laboratories to larger facilities with greater capacity — the requirement for the technology transfer of these products will only increase.
With gene therapy, we are at the dawn of another era of potentially rapid growth in the sector. And companies planning for their futures will once again consider a range of factors in identifying the optimal locations for gene therapy research and production centers.