Parenteral Advisory: Outmoded Fill/Finish Technology
Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?
Process Chromatography Selection for Downstream Processing Applications
Industry experts discuss best practices for selecting a separation technology.
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
Analyzer Automates Cell-Culture Chemistry Analysis
The BioProfile FLEX 2 from Nova Biomedical is a cell-culture chemistry analyzer that allows for automated cell-culture analysis for small-volume culture systems.
Data Logger Provides Ultra-Low Temperature Readings
The OM-CP-CRYO-TEMP ultra-low temperature data logger from Omega Engineering records temperatures as low as -86 °C.
Part II: Enabling Freeze-Thaw Stability of PBS-Based Formulations of a Monoclonal Antibody
This study offers a strategy for stabilization of biotherapeutics for long-term frozen storage in PBS-based formulations.
Manufacturing and Distribution Boundaries Blur
Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.
Modeling Bioreactor Performance
Model effectiveness is determined by the quality and composition of the data inputs.
Implementing a Dual Approach to Protein Characterization
Innovations in electrophoresis and chromatography upstream of protein characterization can accelerate research.
Efforts Accelerate to Streamline Postapproval Change Process
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
Innovation vs. Capacity: How CMOs Compete
The strategies of a innovation-driven CMO may be different than a capacity-driven CMO.
BioPharm International, September 2016 Issue (PDF)
Click the title above to open the BioPharm International September 2016 issue in an interactive PDF format.
PDA Issues Call to Action for Faster Postapproval Changes
The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.
When Marketing and Medicine Collide
Steep price increases for a popular drug have created patient and Congressional backlash.
