Wednesday, January 16, 2019 Daily Archives

Integrated Solutions for Biologics Formulation and Drug Product Development

This webcast features: Dr. Yunsong (Frank) Li, Director of Process Development, Catalent Biologics There are many challenges to conduct thorough drug product formulation development at early stage drug substance process development. Those challenges include material limitation, suitable analytical method, time and labor cost. Sufficient development of the right formulation and dosage form for biologics products early on helps to avoid formulation redevelopment and change during the later stage of product development, which leads to additional analytical, pharmacokinetics or even clinical…

Cell and gene therapies: FDA expects 10 to 20 approvals per year by 2025

The US FDA predicts it will receive more than 200 regenerative INDs per year from 2020 and will add 50 additional staff to review these products. There has been “a large upswing in the number of investigational new drug (IND) applications†for cell and gene therapies received by the US Food and Drug Administration (FDA), commissioner Scott Gottlieb and Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) said in a statement yesterday. The Agency has so…