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. In a worst-case scenario, the inability to deliver from any part of a new supply chain could impact the clinical program and launch schedule. There are also major technical and quality risks that could place the supply chain on a critical path. Ultimately, the patient could suffer if the supply chain fails to deliver.
This is why BioPhorum has published a Guideline for Materials Introduction Supporting Drug Substance Delivery, which contains a standard process map and a set of simple tools for a structured approach for materials introduction across the supply chain.
It summarizes a stepwise process when introducing a material to support new drug substance manufacture and can be used in conjunction with detailed, company specific NPI procedures. The guidance is also relevant for cell and gene therapy manufacturers.
The concept divides the materials introduction and supply process into four distinct phases or ‘stage gates’. Each stage gate discusses the inputs/deliverables and activities needed to successfully complete each stage.
The stages are:
1. Establishing product lifecycle materials requirements
2. Materials evaluation
3. Supplier selection and qualification
4. Manufacture and business review.
Improving the supply chain
Overall, a comprehensive and robust NPI process will improve supply chain efficiencies through collaboration between suppliers and drug manufacturers. Specific benefits include standardized planning/tracking of documents, capturing risks at each stage, having a Business Review Process (that includes ‘innovation’ discussions) and agreeing on a single set of forecast requirements between suppliers and customers.
It will also reduce the cost of poor quality while increasing schedule adherence, a robust lifecycle management via Business Review Meetings and better visibility of supplier relationships, which will create trust.
The NPI process is an excellent opportunity to capture all the correct information on raw materials from the supply chain to support the development of the new product through its lifecycle. Done correctly, it avoids possible retrospective work at different stages of the product when issues occur. When working with development, manufacturing, operational and quality teams, it is an essential risk mitigation practice to ensure a successful outcome for the NPI.
It ensures that all the master data information needed to support the use of raw materials is present and correct, and that you can plan the supply of those materials with a robust, resilient supply chain that supports the supply of the materials for your production facilities.
The NPI process is a critical activity to support any new product being brought onto the market – especially during the pandemic when demand is high – and ensures you have the capacity to rapidly flex up and down in response to demand. It is critical to share information with your suppliers and their supply chains, so they understand your needs and expectations when you are introducing a new product either into a single market or globally. The guideline supports recent BioPhorum Supply Partner documents, such as a best practice guide for forecast and demand planning and a forecast and demand planning toolkit, that were developed to help companies and their suppliers be better at forecast and demand planning.