Guidelines for materials introduction supporting drug substance delivery

There are many challenges during drug substance supply in a biopharmaceutical new product introduction (NPI) process. Clinical supply programs are frequently subject to change and therefore supporting drug substance (active pharmaceutical ingredient (API)), supply requirements can be extremely variable. Given this unpredictability, key supply issues can arise, such as:

  • Traditional forecasting and demand processes for managing a biopharmaceutical NPI are often unable to ensure a robust supply performance. Therefore, API customer schedule adherence becomes extremely challenging
  • NPI manufacturing processes are often characterized by their lack of robustness and predictability at this early stage of development
  • Manufacturing operations can also encounter complex and diverse NPI supply chains, which may be partly external to their plants, utilize novel ingredients/platforms or be in-licensed because of an acquisition.

In a worst-case scenario, the inability to deliver from any part of a newly created supply chain could impact the clinical program and launch schedule. There are also significant technical and quality risks that could place the supply of drug substance on the critical path of a clinical program. Ultimately, the patient could be impacted if the supply chain does not deliver to promise.

This area has been a significant focus for BioPhorum Supply Partner (SPP).  To improve NPI business operations, the team recognized that a specific NPI biopharmaceutical supply process, focusing on materials introduction, could be collaboratively developed between API manufacturers and their suppliers.

Members of the Forecast and Demand Planning Workstream have developed a standard process map providing industry with a set of simple tools containing a structured approach for materials introduction across the supply chain. It summarizes a stepwise process that can be used as a guideline for introducing a material to support new drug substance manufacture and can be used in conjunction with detailed, company-specific NPI procedures. The guidance is relevant best practice for cell and gene therapy manufacturers too.

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Guidelines for materials introduction supporting drug substance delivery November 2021.pdf
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