For most biotech sponsors, the choice of a Contract Development and Manufacturing Organisation (CDMO) is one of the most consequential decisions of the programme. Once a contract is signed, the sponsor has effectively handed over a significant share of the technical, quality and regulatory destiny of the asset. The decisions that the CDMO takes on process parameters, documentation maturity, analytical method transfer and deviation management will surface in the IND or IMPD do

A CMC strategy for IND or IMPD submission is more than a checklist. A practitioner's view on the elements that most often decide whether a submission moves or stalls.

In early-stage biotech, the conversation tends to be dominated by the science. Target validation, proof of concept, mechanism of action, preclinical signals. These are the areas where founders, CSOs and investors spend most of their attention, and understandably so. The science is what justifies the next round of funding and the next development decision. What often receives less attention is a more quiet risk that runs alongside the science from the very first months of a pr

Preparing a marketing authorization application—whether a New Drug Application (NDA) for small molecules or a Biologics License Application (BLA) for biologics—represents the most herculean effort a biotechnology organization can undertake. For leaders—CEOs, CSOs, and CTOs—of growing biotechs, this moment is not just an administrative step, but the culmination of years of rigorous research, massive investment, and constant technical challenges. At 3Biotech, we view this proce