Wyeth BioPharma has identified cycle-time reduction as critical to customer responsiveness and the success of commercial and pipeline products. In formulating a plan of attack, the company focused on two aspects of cycle time: the global planning process and disposition cycle times. While the latter is a traditional concern of cycle-time reduction efforts, the former is a little out of the ordinary because it deals with data flow and timeliness of capacity scheduling. The benefits of Wyeth's cycle-time reduction efforts include inventory reduction, increased bioreactor capacity, improved responsiveness to customer demand, significant improvement in product launch timelines, a shorter feedback loop from downstream processes to upstream quality, and reduced inventory exposure in the event of quality non-compliance.
SUPPLY CHAIN OVERVIEW AND CHALLENGES
BeneFIX is a recombinant Factor IX used for the treatment of hemophilia B, a hereditary blood clotting disorder. Wyeth is the only manufacturer of a commercial recombinant Factor IX; all other products on the market are derived from human plasma, with its associated infectious risks. FDA approved BeneFIX in 1997 and EMEA approved it for Europe in 1999. It has attained a market share of more than 80% in the US and more than 45% in Europe. The active ingredient (drug substance) of BeneFIX is manufactured in two of Wyeth's five cell culture and purification suites in Andover, Massachusetts, and contract manufactured in one cell culture and purification suite in Glaxo Smith Kline's Conshohocken, Pennsylvania, facility. All drug product is contract manufactured by Hospira (formerly Abbott) in McPherson, Kansas. Hospira also performs packaging for the US, Canadian, Asia-Pacific, and Latin American markets. Baxter BioScience markets BeneFIX in Europe and performs all European packaging at their Lessines, Belgium facility.
Some of the challenges presented by the BeneFIX supply chain include the following:
1. The supply chain crosses many geographies, companies, and IT platforms.
2. The corporation has limited supply chain data visibility and validation, and a longer-term, global solution enabling total supply chain visibility is years away.
3. Supply chain management has historically been based primarily on internal and external communication via purchase orders.
4. Manufacturing site planning is conducted strictly within the local enterprise resources planning (ERP) environment, focused on local optimization.
5. Global supply chain planning is conducted in an Excel-based environment.
6. Excessive cycle times and cycle time variability add to uncertainty at decision making points.
7. Regulatory filings can create capacity and material-sourcing constraints, necessitating characteristic-based planning when there are two plants making the same protein but one is approved globally and one is approved only in the US.
Historicially, the lack of data availability and total supply chain visibility has meant that demand signals are communicated through the supply chain via internal and external purchase orders. For example, imagine that events in a country result in a significant positive or negative change to that country's forecast. The country's purchasing process typically takes a six to 12 month view of their own requirements to meet market demand and their on-hand and in-transit inventory before placing a purchase order with their packaging supplier. The packaging site then performs a manufacturing resources planning (MRP) process: consolidating purchase orders for all the countries they supply with this product, accounting for on-hand and in-transit inventory, and placing a purchase order with the drug product manufacturer. Again, following an MRP process, the fill and lyophilization site calculates net requirements for protein and places a purchase order with the drug substance manufacturer. Although the distribution requirements planning (DRP) and MRP logic may be sound as the demand signal makes it way through the supply chain, it is not uncommon to see monthly execution frequency result in a four to five month delay before the demand signal reaches the drug substance facility.
Supply Chain Overview