11.05.19 -- FDA FY2018 Human Tissue & Cell Therapy Observations, Trends
The BioProcessing Asia Conference was created to advance the contribution of bioprocessing sciences, products, and medical interventions to the region. This e-book provides an illustration of the cutting-edge presentations, from the sustainability of biosimilars, to the regulatory climate in Asia, to the challenges facing the international bioprocessing community and the latest technologies for viral vector/vaccine production. Some of the articles you’ll find within the e-book are:
White Paper |
by Shawn Opatka,Werum IT Solutions America, Inc.
This white paper addresses the unique production problems of cell and gene therapy and explains how a manufacturing execution system (MES) can address them. It provides guidance on how to select an MES and a case study of two CAR-T therapy companies scaling up with and without an MES.
By Herman F. Bozenhardt and Erich H. Bozenhardt,Integrated Project Services (IPS)
One of the most significant moves for a growing biotech or pharmaceutical company — sometimes considered as a graduation step — is the acquisition of property to conduct clinical trials and manufacture commercial products. In the first installment of this two-part series we will explore what considerations companies need to make before they decide what type of property to pursue.
Decades of painstaking research have recently begun to yield gene therapy products that are delivering meaningful benefits to human health. With the rapid evolution of the gene therapy field, regulatory agencies have been working to keep pace with these scientific and clinical breakthroughs. An understanding of the regulations and guidance documents reflecting regulator current thinking surrounding gene therapies is essential to success.