February 2020
Volume 33, No. 2 |
|
|
|
|
|
|
| COVER STORY |
Cynthia A. Challener
Analytical solutions are improving for raw material testing, process development, drug product release, and more.
read more
| DEVELOPMENT |
Felicity Thomas
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.
read more
|
|
|
| BioPharm International February Issue
|
|
| UPSTREAM PROCESSING |
Feliza Mirasol
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.
read more
| DOWNSTREAM PROCESSING |
Feliza Mirasol
Developers need to transcend the limits of existing separation technologies, to maximize vector recovery while preserving therapeutic potency.
read more
| FORMULATION |
Felicity Thomas
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.
read more
| MANUFACTURING |
Feliza Mirasol
The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.
read more
| ANALYTICS |
Aaron O. Bailey
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.
read more
| QUALITY/REGULATIONS |
Lauren Lavelle
Data management is crucial in bio/pharmaceutical laboratory settings from discovery steps through clinical studies and varies based on the development phase.
read more
| OPERATIONS |
Agnes Shanley
Vein-to-vein programs are focusing on data access and traceability.
read more
|
|
|
|
| FROM THE EDITOR |
Rita C. Peters
Bio/pharma researchers mobilize to diagnose and treat patients in pandemic threat.
read more
| REGULATORY BEAT |
Jill Wechsler
Increased reliance on foreign producers raises concerns and spurs collaborations.
read more
| ASK THE EXPERT |
Susan J. Schniepp
CH 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.
read more
|
|
| EVENTS |
February 18–20, 2020
February 23–26, 2020
March 10–11, 2020
more events
|
|
|
|
|
|
Learn More ››
