Author Archives: Paul Killian

Adopting a Fully Single-use Process to Improve Speed to Clinic: A Leachables Case Study

The implementation of single-use technologies for pharmaceutical product development continues to gain momentum; this trend is due to the advantages of increased flexibility, speed of implementation and lower capital investment. In particular, they are seen as a means to accelerate the production of material for clinical trials. However, a primary concern regarding the use of such technologies is the impact and level of leachables in the final drug substance. Typically this concern is addressed through a risk assessment utilizing extractable…

Adopting a Fully Single-Use Process to Improve Speed to Clinic: A Leachables Case Study

The implementation of single-use technologies for pharmaceutical product development continues to gain momentum; this trend is due to the advantages of increased flexibility, speed of implementation and lower capital investment. In particular, they are seen as a means to accelerate the production of material for clinical trials. However, a primary concern regarding the use of such technologies is the impact and level of leachables in the final drug substance. Typically this concern is addressed through a risk assessment utilizing extractable…

PureFlex™ Plus Single-Use Process Container Film Extractables and Leachables Study

Biopharmaceutical companies are using single-use disposable sterile containers and assemblies for upstream and downstream processes at an ever increasing rate, as these specialized technologies and products enable efficient and scalable processes. The newly developed PureFlex™ Plus film contains many of the same ultra low density polyethylene, poly(vinyl acetate) and poly(vinyl alcohol co-ethylene) layers that are in current PureFlex™ film.  The only modification is the outer layer, to provide enhanced mechanical strength, creep resistance and limited permeability to air and gases.…