Plant molecular farming (PMF) has been promoted since the 1990s as a rapid, cost-effective
and (most of all) safe alternative to the cultivation of bacteria or animal cells for the …

After more than 60 years, the conventional production of influenza vaccines employing
fertilized chicken eggs has reached its limits–both in terms of temporal flexibility and vaccine …

In drug delivery, the development of nanovesicles that combine both synthetic and cellular
components provides added biocompatibility and targeting specificity in comparison to …

Biological products can contain residual DNA from host cell substrates. It is therefore
possible that such residual DNA could encode or harbor oncogenes and infectious agents …

Vaccines are complex products that are manufactured in highly dynamic processes. Cellular
substrates are one critical component that can have an enormous impact on reactogenicity …

Residual DNA (rDNA) is comprised of deoxyribonucleic acid (DNA) fragments and longer
length molecules originating from the host organism that may be present in samples from …

During the production of cell and gene therapy products, residual host cell DNA (HCD) could
cause safety risks of the biological products, and the longer the residual HCD fragment, the …

The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product
should be based upon a thorough understanding of both the product and the manufacturing …

Drug development is an iterative process. The recent publications of regulatory guidelines
further entail a lifecycle approach. Blending data from disparate sources, the Bayesian …

Recombinant human collagens have attracted intensive interest in the past two decades,
demonstrating considerable potential in medicine, tissue engineering, and cosmetics …