Introduction to current and future manufacturing processes features and timings
Standard products, including recombinant biotechnological ones and newly developed mRNA vaccines, rely on manufacturing processes performed at pharmaceutical companies’ sites with validated equipment, processes and analytical methods: batches are manufactured with a standard process, analyzed according to predefined specifications and then released by site’s QPs for clinical or commercial purposes. Regarding timeframes and thinking about a recombinant biotech product, as a worst case, the overall manufacturing process can last even for 2 months (or also longer); final drug product manufacturing, analysis and release prolong timelines of an additional one month, making the final product Lead Time quite consistent, with a realistic mean of 3 months from cell thawing up to final shipment to patients.