Feliza Mirasol is the science editor for BioPharm International.
QbD Improves Cell-Culture Process Control
A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.
Single-Use Bioreactors Pose E&L Challenges
A roundtable Q&A with biopharma executives elucidates the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process.
Roadmap Leads to Innovative Biomanufacturing Strategies
The Biomanufacturing Technology Roadmap is accelerating innovative manufacturing strategies for biopharmaceuticals.
PAT From a Small-Molecule Vantage Point
Small-molecule therapeutics can also benefit from the implementation of PAT in the manufacturing process.
Therapeutic Vaccines Target Cancer and Other Viral-Induced Diseases
The use of therapeutic vaccines presents a new way to manage diseases, such as cancer and sexually transmitted diseases.
Connector Integrity in Single-Use Biomanufacturing Systems
Connectors are a critical element in the process optimization of single-use bioprocessing systems.
ADC Development Robust Despite Lackluster Performance
Despite the disappointing therapeutic performance of ADCs thus far, the pipeline still boasts promising prospects.
The Challenges of PAT in the Scale-Up of Biologics Production
Process analytical testing for biopharmaceuticals requires enhanced methods due to complex bioprocesses.
Overcoming Hurdles in Emerging Therapy Development
The development of emerging therapies poses unique manufacturing and formulation challenges for drug developers as candidates like cell and gene therapies advance through the pipeline.