Internal and External Challenges to Biopharma in 2019
Pricing pressures, investment volatility, and government disfunction greet Biopharma in 2019.
The Impact of Expedited Review Status on Biomanufacturing Facility Design
For rapid scale-up of biomanufacturing under expedited review status, facility design must better integrate product development and manufacturing lifecycle activities.
Matching Personal and Company Success
Compensation and professional challenges are key pieces to solving the biopharma employee satisfaction puzzle.
Identifying Incentives to Adopt Advanced Manufacturing
Bio/pharma companies are successfully launching novel therapies; however, the industry still needs to work on manufacturing innovation.
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
A Look at the Affinity Chromatography Landscape
New ligands are being developed to meet the separation and purification needs of next-gen biologics.
The Role of Automation in Cell-Line Development
Automation in cell-line development and cell culture is leading to more consistent quality while improving efficiency, and, ultimately, speed to market.
CDER Priorities for 2019: Opioids, Quality, Safety, and Innovation
FDA plans to support initiatives to ensure that all medicines are safe, effective, and of high quality.
Global Inspection Harmonization
Understanding the differences in inspection processes is the key to successful global expansion, according to Siegfried Schmitt, PhD, vice-president Technical, PAREXEL Consulting.
The Outlook for CMO Outsourcing in 2019
Outsourcing of manufacturing activities is expected to increase in 2019.
Efficacy of a Simple Static Cleaning Procedure for SPTFF
A key technology that can help achieve a continuous production flow is single-pass tangential flow filtration.
BioPharm International, January 2019 Issue (PDF)
Click the title above to open the BioPharm International January 2019 issue in an interactive PDF format.
