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BioPharm International-02-01-2020
BioPharm International
Managing Risk for Cell and Gene Therapy Logistics
February 05, 2020
Operations
33
2
Vein-to-vein programs are focusing on data access and traceability.
The Call for a Rapid Response
February 01, 2020
From the Editor
33
2
Bio/pharma researchers mobilize to diagnose and treat patients in pandemic threat.
Data Management Practices
February 01, 2020
Quality/Regulations
33
2
Data management is crucial in bio/pharmaceutical laboratory settings from discovery steps through clinical studies and varies based on the development phase.
Biopharma Analysis Benefits from New Technology and Methods
February 01, 2020
Cover Story
33
2
Analytical solutions are improving for raw material testing, process development, drug product release, and more.
Cell Therapies: The Living End of Growth Opportunities
February 01, 2020
Development
33
2
The commercialization of cell therapies is still at its infancy, but industry is facing an exciting period of development as the sector is expected to grow exponentially.
Fresh Thinking in Biologic Drug Formulation
February 01, 2020
Formulation
33
2
Biologics raise unique formulation and development challenges, and industry is still on a learning curve to get the best out of these diverse and complex therapies.
How Advanced Mass Spectrometry Technologies and Workflows are Delivering Comprehensive Protein Characterization
February 01, 2020
Analytics
33
2
Complex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.
The Need for Advanced Process Modeling for New Therapeutic Biologics
February 01, 2020
Manufacturing
33
2
The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.
Cell Culture Variables for Gene Therapy Vectors
February 01, 2020
Upstream Processing
33
2
The production of viral vectors for use in gene therapy benefits from being able to use similar cell-culture processes as mAbs, but it faces limitations under current cell-culture technologies.
Challenges in Vector Purification for Gene Therapy
February 01, 2020
Downstream Processing
33
2
Developers need to transcend the limits of existing separation technologies, to maximize vector recovery while preserving therapeutic potency.
Global Supply Issues Create Challenges
February 01, 2020
Regulatory Beat
33
2
Increased reliance on foreign producers raises concerns and spurs collaborations.
BioPharm International, February 2020 Issue (PDF)
February 01, 2020
Issue PDF
33
2
Click the title above to open the BioPharm International February 2020 issue in an interactive PDF format.
ICH to Revise Quality Risk Management Guideline
February 01, 2020
Ask The Expert
33
2
ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.