Supply Chain

Data Management in the Supply Chain

Adopting an effective strategy for data and knowledge management throughout the drug development and clinical manufacturing lifecycle is key to maintaining a competitive edge. Significant challenges face each organization seeking to improve efficiency in this area, and they can mostly be attributed to the complex nature of pharmaceutical drug development. Managing both data and knowledge is complicated by the different groups, sites, and partner organizations involved with developing and manufacturing a new drug product. To further compound the problem, a…

Reconsidering the Supply Chain

An emerging challenge for biotech companies is understanding the bigger picture: How should manufacturing facilities be configured to link together process technologies? Should plants be highly flexible or focus on process standardization? How would a disruptive new technology affect current supply chains, and how could it be implemented? Meeting the challenge requires a complete and detailed understanding of supply chains. Much current focus in process development is on improving operations, with limited consideration to how improvements affect “big picture” variables.…

Guide to Disposal of Single-Use Bioprocess Systems

Single-use bioprocess systems can provide a range of environmental benefits beyond those of stainless steel systems. Although single-use systems may generate additional solid waste, benefits include reduction in the amount of water, chemicals, and energy required for cleaning and sanitizing as well as avoiding the labor-intensive cleaning processes required with stainless steel systems (1, 2). One of BPSA’s core activities is to educate users and develop guides on issues pertaining to single-use systems. The organization’s disposals subcommittee was chartered to…