Excellent piece. I’ve had people say to my face “we don’t know what’s in them.” Which is when I get to say, hi, let me first explain what “CMC Regulatory Affairs” is, and then point out that it’s my actual profession. Sigh.
I spent like 2 hours talking about host cell protein residual testing today 🫠 and I don’t even work in CMC 😂 it is SO frustrating— and yet they are all selling unregulated supplements and unapproved “health tests”
Yep, I work in biologics, so I’ve seen plenty of HCP data! I always wonder if the phrase “host cell proteins” would sound vaguely sinister to some people.
Very well done and thorough. If one is not in the business of producing vaccines, therapeutics or diagnostics (even academic scientists), they don't realize that QMS/GMP processes require an exhaustive level of control. One minor tweak - B cells differentiate to plasma cells to produce antibodies.
Yup, I discuss B cell differentiation and affinity maturation and class switching in the more comprehensive article I wrote previously — kept the verbiage simple here, but plasma cells are a type of B cell if we want to get semantic 🙃
Excellent piece. I’ve had people say to my face “we don’t know what’s in them.” Which is when I get to say, hi, let me first explain what “CMC Regulatory Affairs” is, and then point out that it’s my actual profession. Sigh.
I spent like 2 hours talking about host cell protein residual testing today 🫠 and I don’t even work in CMC 😂 it is SO frustrating— and yet they are all selling unregulated supplements and unapproved “health tests”
I'm just hoping that after RFK Jr. gets going, vaccines will still be available. 🙄 Thank you for the explanation, Dr. Love.
Yep, I work in biologics, so I’ve seen plenty of HCP data! I always wonder if the phrase “host cell proteins” would sound vaguely sinister to some people.
This is all amazing, the work you do is relentless and exhausting I’m sure, thanks for making me so much smarter.🙏
Very well done and thorough. If one is not in the business of producing vaccines, therapeutics or diagnostics (even academic scientists), they don't realize that QMS/GMP processes require an exhaustive level of control. One minor tweak - B cells differentiate to plasma cells to produce antibodies.
Yup, I discuss B cell differentiation and affinity maturation and class switching in the more comprehensive article I wrote previously — kept the verbiage simple here, but plasma cells are a type of B cell if we want to get semantic 🙃