Single Use Technology Featured Articles

1. How Can You Mitigate The Risks Of Single-Use Bags? 8/24/2015

   The loss of product as a result of bag failure isn’t just an annoyance; it’s an expense, and a costly one at that. However, Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, says with proper fitting and handling, these concerns can be mitigated.

2. Making The Switch To Single-Use: Have You Thought Of Everything? 8/19/2015

   In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.

3. Are Your Single-Use Sensor Tests Set Up To Fail? 7/9/2015

   When it comes to testing methods, experts warn that the same testing methods used on stainless-steel sensors should not be used for single-use sensors. If an attempt is being made to recreate results achieved with a traditional sensor, it’s very possible for those results to appear unfavorable with a single-use sensor.

4. Standardized Extractables Testing Advances Single Use Adoption 6/3/2015

   The Standardized Extractables Testing Protocol For Single-Use Systems In Biomanufacturing written by BPOG members last year establishes a foundation from which to create a standardized approach to extractables testing. However, since its release, there have been some questions and discussions about how to effectively implement the protocol.

5. Single-Use Standardization: Is It Holding Back The Biopharma Industry? 6/1/2015

   The data from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production speaks to the industry’s ongoing desires for standardization in single-use devices. As usage of these disposable devices increases, the gap between the importance of standardization and end-users’ satisfaction with their supplier’s standardization efforts has steadily been worsening. 

6. WIB Profile: Sponsors And CMOs Require Production Flexibility 5/19/2015

   Drug manufacturers today are increasingly demanding flexibility in their manufacturing processes. So who better to provide those solutions than someone who has spent her career dealing with change.

    

7. Top Single-Use Suppliers Make Standardized Equipment A Reality – Part 2 5/8/2015

   Industry experts offer the benefits of standardized single-use equipment to both suppliers and users, as well as how it addresses some of the biggest objections to equipment standardization, as well as offer insight from the eyes of a user.

8. Is The Single-Use Standardization Debate Slowing Down Adoption? 3/16/2015

   Without single-use standardization, the customization required to build a single-use facility may prevent a full-scale adoption of single-use technology. So how do we move forward? Maybe, by taking a look back.

9. Merck Champions Single-Use By Addressing Emotion Vs. Science 3/2/2015

   Lowering the cost of medication is the key to the US gaining a stronghold on the global pharmaceutical market. As anyone knows, in order to lower the cost of medication, the cost of manufacturing will need to be lowered as well. According to Chris Smalley, Ph.D., director of validation compliance at Merck, single-use technology (SUT) could be the hero. 

10. WIB Profile: Emerging Markets Drive Growth In Biologics 2/12/2015

    I was able to catch up with Daniella Kranjac, integration leader and head of commercial operations, to discuss her position with GE Healthcare and the trends she sees occurring in the biologics market.