OR WAIT null SECS
March 02, 2019
As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.
Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.
Containment valves and smart monitoring can keep employees safe and improve manufacturing efficiency when handling potent APIs, intermediates, and solid-dosage drugs.
While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.
March 01, 2019
STA Pharmaceuticals and BioLingus have announced the formation of an exclusive technology and marketing collaboration for sublingual delivery.
The technology uses a silica nanoparticle to deliver vaccines and cancer treatments.
The Coalition for Epidemic Preparedness Innovations (CEPI) and CureVac partner to develop a transportable mRNA vaccine manufacturing platform.
A project conducted by research institute CEA-Leti led to the development of a new HIV vaccine approach based on engineered lipid nanoparticles.
February 22, 2019
Valitacell and Solentim, have announced a collaboration aimed at the acceleration of discovery and development of biologic drugs and advanced cell therapies.
In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.