Process Development

Support for all stages of process development

Porton Advanced has well-trained and highly experienced teams that provide flexible process development support to suit the different needs of our clients. We cover preclinical, clinical Phase I, clinical Phase II and III, and also commercial stages of drug development.

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.

A man in a lab coat is working on a machine.

Technology Transfer

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.

Tailored Services

For clients and projects that require process development support, we provide a full range of tailored services, including scale-down modeling for process development, design of experiments (DOE) for process optimization and scale-up processing to meet different scales of production. We also support NDA submissions by characterizing and validating processes based on the principle of quality by design

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