Randi Hernandez

While the measurement of the toxicity of leachables is not always a required parameter, the information collected during these studies could inform future bioprocessing runs.

Single-use bags containing toxic or hazardous materials required special handling.

The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.

BioPharm International speaks with a CMO to find out how it is coping with capacity challenges, regulatory authority scrutiny, supply chain reliability, and new requests from clients to incorporate continuous manufacturing into processing lines.

Can bioprocessing runs be consistently replicated in an inherently variable production environment?

Improving the bioreactor growth environment increases the rigor of bioprocessing runs.

The number of deficiencies found in foreign and UK-based facilities increased in 2016.

GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.

The mAb is the first approved treatment that targets the progressive form of the disease.

Richard D. Braatz, PhD, will discuss using mathematical models to design a continuous drug manufacturing plant and the differences between batch and continuous operations for biologics.