Capsugel, a global leader in delivering high-quality, innovative dosage forms and solutions, announced the broad commercial availability of its Modular Automated Sampling Technology (MAST) system, which directly transfers samples from bioreactors to analytical devices while maintaining process sterility.
This first-of-its-kind technology allows aseptic collection of accurate, representative samples that generate detailed process information in real-time. MAST represents the latest innovation developed by Capsugel to address biopharmaceutical product development and processing challenges.
"Capsugel's MAST system meets a pressing industry need for improved bioprocess guidance," said David Lyon, Ph.D., Head of Biotherapeutics, Capsugel.
"Real-time product-quality-attribute control is now being used to maximize protein manufacture in bioreactors. This game-changing advancement gives our customers confidence that their samples are representative of their entire batch and that sterility is maintained."
MAST provides a modular system that is readily scalable and suitable for use throughout the product development process.
The system instantaneously provides a wide range of information at the molecular level for media, cells and bioreactor products, allowing for rapid response to maintain optimum bioreactor conditions and maximize yields.
The commercial availability of the technology is the culmination of a focused five-year program conducted by Capsugel's Bend, Ore. facility, in collaboration with several of the world's largest biopharmaceutical companies.
The company has also developed alliances with numerous leading analytical equipment suppliers to facilitate process analytical technology (PAT) integration into bioprocessing through MAST.
"Our rigorous testing and collaborative work with equipment manufacturers and end users has demonstrated the MAST platform's reliability, accuracy and value," commented Clint Pepper, Ph.D., head of the MAST program at Capsugel.
"MAST's integrated design has enabled increased sampling frequency and reproducibility, as well as improved data reliability when compared with manual sampling."
MAST provides for tailored system design and can be readily expanded with additional sampling modules as required. MASTconnect™ software allows for configurable, flexible and user-friendly operation of the MAST system, with special modules for sample scheduling, sample navigation and analytical data management.
Capsugel designs, develops, and manufactures a wide range of innovative dosage forms for the biopharmaceutical and consumer health and nutrition industries.