Antibody drug conjugates (ADCs) are an important new modality that is showing great results in treating certain types of cancer. Manufacture of this drug class is complex insofar as it requires several GMP intermediates as inputs to the conjugation reaction to produce the drug substance. My team of technical consultants at Alira Health has a focus on biologics, and we do a lot of work with ADCs. I'm excited to announce publication of an article from my team entitled “Manufacturing challenges of therapeutic antibody-drug conjugates” by Dr. Peter Alexander and colleagues. The article appears as a featured report in the September 2023 issue of BioProcess International. Read the full article here: https://lnkd.in/gs_TyPe4
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6moI was concerned how the original report of 7,406 replies/letters to the docket would be reviewed. I was thinking that this might be a task for AI/LLM. I look forward to learning more about the breakdown of these letters.