Biopharmaceutical Fill and Finish: Technical and Operating Challenges for the Latest Formulations and Devices
This eBook reports on the technical and operating challenges impacting the latest formulations and devices including: outsourcing, contamination, standardization (pre-filled syringes), lyophilization, and serialization. Get informed on the current state-of-the-art technologies in fill and finish to ensure your product development efforts take full advantage of the innovation in this area of biomanufacturing.
Extractables and Leachables: Standardizing Approaches to Manage the Risk
The implementation, maturation, and benefits of single-use technologies in biopharmaceutical development and manufacturing are well documented and understood. As analytical methods and testing services also rapidly improve, it is clear that management of risk associated with extractables and leachables also must evolve. Standardization is universally accepted as a goal; how to define, implement, and educate the industry is where debate resides.This BPI eBook reviews the industry’s approach to leachables and extractables to address an underlying question: How close are we to making standardization a reality?
BPI Lab: Essential Technologies for Development, Characterization, and QA/QC
There’s a secret hiding in plain sight: many analytical methods and technologies initially designed for pre-clinical development have equally important applications in commercial development. BioProcess International and BioTechniques, partnered to create this special eBook, highlighting and detailing fourteen analytical technologies that provide laboratory technicians and scientists with vital information to help project managers and engineers make educated decisions that ultimately affect every company’s bottom line.