Is this you? As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.
Claim your profile
By Lara Stevanato, PhD, Ergomed Associate Director, Regulatory Affairs Preparing Module 3 of an Investigational New Drug (IND) application is one of the most complex steps in advancing cell and gene therapy (CGT) products into clinical development. As part of the electronic common technical document (eCTD), Module 3 contains the Chemistry, Manufacturing, and Control (CMC) information that demonstrates product safety, quality, purity, identity, and potency.
By Lara Stevanato, PhD, Ergomed Associate Director, Regulatory Affairs Preparing Module 3 of an Investigational New Drug (IND) application is one of the most complex steps in advancing cell and gene therapy (CGT) products into clinical development. As part of the electronic common technical document (eCTD), Module 3 contains the Chemistry, Manufacturing, and Control (CMC) information that demonstrates product safety, quality, purity, identity, and potency.
We describe a method for preparing a cell block from a very sparsely cellular cytology fluid sample. The aim is to ensure that cells are not lost during processing. We developed this method to perform immunohistochemistry on circulating tumour cells (CTC) extracted from the blood of patients with metastatic carcinoma, in which there are typically less than 20 cells in a 10 mL blood sample.
We describe a method for preparing a cell block from a very sparsely cellular cytology fluid sample. The aim is to ensure that cells are not lost during processing. We developed this method to perform immunohistochemistry on circulating tumour cells (CTC) extracted from the blood of patients with metastatic carcinoma, in which there are typically less than 20 cells in a 10 mL blood sample.
As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.
