For clients in later clinical and commercial stages with an already established manufacturing process, we can support large-scale production and perform technology transfer services. We help with process characterization and validation (PPQ) in clinical phase III to support NDA submission and commercialization. Finally, for clients in preclinical and early clinical research stages, we provide full process development, optimization, and scale-up/scale-out GMP manufacturing support.
Effective and efficient technology transfer is key to the success of CDMOs. At Porton Advanced, we have an established tech transfer process in which we take a stepwise approach, starting with a gap analysis of the raw materials, cell banks, USP, DSP and DS/DP manufacturing. The analysis and assessment consider, process equipment and parameters across USP/DSP, critical quality attributes against the ‘target quality product profile’ of the drug product, etc.
At Porton Advanced, we have established a clear technology transfer process by generating a gap analysis of raw materials, cell banks, USP, DSP, DS/DP manufacturing, etc., We then evaluate the process equipment and parameters across the USP/DSP for key quality attributes of the drug product.
Our specialized tech transfer team will perform in-depth assessments to ensure appropriate resources are allocated, development time and costs are balanced, and timely delivery can be achieved without compromising quality.