January 19, 2022
Trust is important when selecting a contract manufacturing organization (CMO), particularly when offshoring. With more biopharmaceutical companies looking to China-based CMOs, companies need to understand both the opportunities and the challenges the market presents.
November 18, 2021
As any pharmaceutical company knows, most drugs don’t make it into the clinic so the medical chemistry process early on involves just a few kilograms of product. But if all goes well, and the drug makes it into the clinic, suddenly the quantities become metric tons or more, and the manufacturing and safety processes become quite different.
November 4, 2021
Storytelling is integral to the pharmaceutical regulatory process. It’s really what your new drug application (NDA) or biologics license application (BLA) is all about. It’s about deciphering the data to tell a reviewer how your process and product works.
November 1, 2021
Mike Carroll, Quality Professional and Aseptic Processing specialist has an extensive history in microbiology and pharmaceuticals. One of his most recent commentaries is on Microbiological Quality Considerations in Non-Sterile Drug Manufacturing, a draft of guidance published in September of 2021
October 7, 2021
When you’re developing and manufacturing your active pharmaceutical ingredients, the last thing you want to deal with is surprises. Unfortunately, even with the soundest methods, processes, and strategies, problems occur in manufacturing.
September 16, 2021
Start early, document thoroughly. That’s the lesson for getting through the new drug application or biologics license application (NDA/BLA) process. Long before marketing approval, companies developing new products must apply to conduct clinical trials by submitting an investigational new drug (IND).
