Search results for " GMP-compliant"
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
Article
Viral Clearance Challenges in Bioprocessing
In the latter case, a fully GMP-compliant validated production process must be in place. Accordingly, a GMP-compliant viral clearance study is more important for the late stage rather than the early s…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
“Methods exist, but these generally are research-based techniques (such as sequencing, infectivity, transfection assays), and they need to be fully developed to be robust, validatable, GMP-compliant, …
Article
The Good and Bad of Biosimilars
Biosimilars have been around for years, but the biopharma industry – as well as the healthcare community – has been slow to embrace them. Today, however, the competition is really beginning to heat …
Article
CDMOs Driving Emerging Bio/Pharma Success
By relying on CDMOs, emerging bio/pharma companies can get a product into Phase I testing for $2-5 million and in one to two years from when they commence GMP-compliant development. Without the access…
Article
GMP Challenges for Advanced Therapy Medicinal Products
They lack the regulatory expertise and resources to establish and operate GMP-compliant manufacturing processes. In particular, they often do not have adequate systems in place for evaluating the qual…