We welcome you to CPhI in Madrid (Stand 5J10). Complexity and creativity is an increasing feature of the pharma industry, which is demanding lower volumes and more targeted active pharmaceutical ingredients (APIs).
The recent heightened scrutiny of Regulatory Starting Materials requires that manufacturers employ a very rigorous analytical and quality infrastructure. Risk mitigation therefore can only come from cGMP compliant facilities which treat RSM product like the finished API while still giving a cost competitive product.
RSM suppliers are mandatory trusted partners because failure to supply product quality or the necessary track record for each RSM inevitably leads to costly delay. This topic is covered in more detail in the October issue of manufacturing chemist pages 49/50.
As pressure for speed in development increases, SAI argues that there is more to address. The quick and dirty approach to producing development amounts upon candidate selection for phase 0 needs to be replaced with something we call Turbo Tech Transfer or T3. It involves a carefully designed set of activities all aimed at moving fast AND robust to supply pre-clinical needs and in parallel prepare for the next cGMP phase without losing time and quality.
This means ensuring that the med chemists team up with their R&D counterparts, involve analytical development and most importantly, supply chain, all at the same facility.
The comprehensive tech transfer and speed achieved provide the best basis for the new candidates to be confirmed and made ready for clinical development.
SAI has further invested in the required size of reactors and downstream equipment to handle a range of technologies and scales, which is further enhanced through its process engineering expertise. Several innovators are already benefiting from this new capability today and we have case studies at hand to discuss how this can add value to your discovery and development program in full confidentiality.
To view SAI click on: www.sailife.com or visit us during CPhI Madrid, Stand 5J10.
