March 2020
Volume 33, No. 3 |
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| COVER STORY |
Agnes Shanley
Better understanding and control of cell behavior is yielding benefits, upstream and beyond.
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| UPSTREAM PROCESSING |
Feliza Mirasol
The future of raw material sourcing for mAb production may lay in the sustainability of the source and the added benefits of newer technologies.
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| DOWNSTREAM PROCESSING |
Cynthia A. Challener
Ensuring the quality of data in process monitoring and control systems starts in process development phases.
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| BioPharm International March Issue
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| MANUFACTURING |
Jennifer Markarian
Single-use and modular systems will meet demand for rapid implementation at different scales.
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Featured Resources from BioPharm International
View our online resource center, sponsored by GE Healthcare, to explore a case study and articles on gaining and retaining skilled labor, modular bioprocessing, the good and bad of biosilimiars, and more.
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| ANALYTICS |
Felicity Thomas
As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.
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| QUALITY/REGULATIONS |
Feliza Mirasol
While new industry guidance documents issued by FDA speak to the agency’s efforts to promote the development of new gene therapies, certain hurdles remain to challenge stakeholders.
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| OUTSOURCING |
Rita C. Peters
Contract service organizations can offer biopharma companies early insight into dangers that may hinder a drug’s later development.
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| BIOBUSINESS |
Kevin E. Noonan
As patent disputes within the scientific community continue, drug developers consider the intellectual property unknowns associated with this emerging technology.
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| FROM THE EDITOR |
Rita C. Peters
Emergency actions to protect patients and the drug supply may have long-term implications.
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| REGULATORY BEAT |
Jill Wechsler
States, hospitals, and insurers support manufacturing arrangements to ensure access to affordable medicines.
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| ASK THE EXPERT |
Siegfried Schmitt
No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
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| EVENTS |
March 18–19, 2020
March 24–26, 2020
April 2–3, 2020
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