The agency seeks comments on a draft guidance designed to make the process conform to its original intent as a communication tool, rather than a roadblock to competition and innovation.
Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?
Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.
Now that the first genetically modified cell therapies are being manufactured, the industry must move beyond “whatever works” to meet growing demand.
Although downstream efficiency still lags behind upstream, engineering-driven innovation is breaking through boundaries.
Making siloed data accessible across functions and to contract partners is the first step to facilitating continuous improvement and enabling use of artificial intelligence in manufacturing.
More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.
While it may not be getting easier, biopharma patent protection is at least becoming more predictable.
Technology vendors are strengthening their positions in China as the nation emphasizes self-sufficiency in research, development, and manufacturing.
Radha Iyer, vice-president and head of Quality and Scientific Affairs, Global Developed Markets, Dr. Reddy’s Laboratories, discusses new initiatives at the company.