Mainly based on the Drug Products track at the 2017 “BioProcess International Conference and Exhibition” in Boston, this report also includes a submitted case study and discussions from users and suppliers of fill–finish technology. BPI’s senior technical editor reports on the conference track. Presentations focused on predictive modeling, quality by design and process analytics, freezing–thawing and storage, endotoxin control, single-use technologies, analytics, and formulation. In addition, a new Pfizer case study examines single-use solutions for freeze–thaw of a vaccine. And experts address serialization, anticounterfeiting, and streamlining fill–finish operations.
Conference Report: The Drug Product Track at 2017’s BioProcess International Conference and Exhibition in Boston, MA
The Drug Product track at Biotech Week Boston had number of presentations focused on formulation, fill and finish operations. This report highlights the topics and talks from room 310. Talks covered predictive modeling, automation, and in-line monitoring; freezing and thawing; endotoxin control; particles and light exposure; and formulation development. BioProcess International’s senior technical editor provides a take on the key issues these presentations covered.
A Vaccine Case Study: Qualifying Redundant Disconnection Technologies As Container-Closure Systems for Long-Term Storage and Shipping
Biopharmaceutical companies such as Pfizer use process-step-segregation and further improve their plant efficiencies by incorporating single-use platform technologies to harmonize the manufacturing and dispensing of regularly produced BDS and intermediates. A platform analysis revealed that a dual-sourced container closure platform contained a single container–closure and disconnection system. The author team viewed it as a potential risk because it was the sole connection mechanism used across the platform’s design. In an effort to improve process flexibility and robustness, the team concluded that a second container closure and disconnection technology was needed. This paper examines the validation process they used to define robust and redundant disconnection methodologies as container closures.
Beyond Compliance: Serialization Has More to Offer
Advances in technology have certainly increased the efficiencies of today’s businesses, but too many organizational units have become increasingly isolated in silos, limiting opportunities for cross-collaboration and timely information from customers, suppliers and distribution partners. Companies are encouraged to hold meetings with cross-functional groups within an organization to stimulate thought and discussion about these possible benefits. Serialization can be a highly effective solution for facilitating the transfer of timely and comprehensive information throughout the many functional units of an enterprise, its market, and external partners, most importantly, its customers.