» BIOPHARMACEUTICALS » End-to-End Biomanufacturing: Challenges and Opportunities in Implementation Robert Dream Managing Director HDR Company LLC End-to-End (from seed to unit dose - E-2-E) manufacturing represents the next generation of biopharmaceutical manufacturing processes for both large and small molecules. It is recognized by regulatory authorities as a key emerging technology. The FDA has approved various small molecule products and recently issued draft guidance for industry on continuous manufacturing. The International Council for Harmonization issued (ICH) Q135 which has been adopted by the European Medicines Agency (EMA) to support the technology and give guidance as well. Companies can add flexibility and maximize the value of process analytics ICH Q146 to enhance E-2-E manufacturing. It is important to note that regulatory guidance on process analytical technology (PAT) includes ICH Q8(R2),8 " Guidance for Industry " from 2004.9 ICH Q2(R2),7 Figure 1, and FDA's Figure 1. Overview of linkage of ICH guidelines: for a process line from planning-design stage to commercial manufacturing. 26 | | May/June 2023