News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
The draft guidance aims to provide sponsors of virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical...
A new UK “biologics facility of the future” (FoF) testing centre will let biopharma tech firms develop smaller-scale manufacturing systems for personalised medicine production according to the Centre for Process Innovation (CPI).
India is looking to stimulate investment in biotechnology through bioclusters and development of the International Centre for Genetic Engineering and Biotechnology (ICGEB).
Zinc-finger proteins will be at the heart of biomanufacturing innovation in coming years, the head of R&D at SAFC has said.
The FDA has approved Protein Sciences’ strain change amendment for its cell-based seasonal influenza vaccine known as Flublok.