Wednesday, December 11, 2019 Daily Archives

eBook: Speed to IND β€” Balancing Risk and Reward

With so many biopharmaceuticals obtaining breakthrough or fast-track designations, companies that use accelerated strategies to be first in human studies can be left with significant quality and manufacturing challenges that must be solved later on. Despite regulatory encouragement to create solid design spaces and define parameters according to quality by design (QbD), those may go by the wayside given the pressures of speed. The reward is the investigational new drug (IND) application itself β€” but if companies lock in subpar…

Pfizer latest to cite competitiveness of inhouse gene therapy capabilities

With a surge of gene therapies coming through the clinic and a lack of CDMO capacity, having inhouse capabilities is driving investment and M&A activity. As increasing numbers of gene therapies progress through the clinic and towards commercialization, it is no secret that demand for production capabilities is high. The complexity and cost of making viral vector means is a problem, but a biopharma with its own capabilities holds a major advantage, it would appear, something Pfizer CSO Mikael Dolsten…

GE and Guangzhou gov bring bioprocess training to China

A single-use bioprocessing training facility in Guangzhou will help attract and retain biopharma talent in the burgeoning China market, says GE Healthcare. Bioprocess vendor GE Healthcare Life Sciences and Guangzhou Development District government have invested a total of $10 million (€9 million) to establish a biomanufacturing training center in the Guangdong province in China. The Guangzhou Bioprocess Academy aims to train over 1,000 people annually when it opens in September next year and is needed to feed the the rapid…