| MANUFACTURING |
Jennifer Markarian
Understanding of scale-up parameters and use of process analytical technology are important to meet demand for larger batch sizes.
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Feliza Mirasol
Tackling process development early on can better optimize manufacturing processes for emerging therapies.
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| PEER-REVIEWED RESEARCH |
Robert Shaw, Marie South
The authors present a simple-to-use Microsoft Excel-based statistical tool that uses cumulative sum techniques to aid retrospective understanding of data trends.
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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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| OPERATIONS |
Jennifer Markarian
Energy and water waste can be improved with new technologies, and sustainability can be considered in the design of new facilities.
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| OUTSOURCING |
Rita C. Peters
Can investing in early formulation studies drive a new therapy successfully across the commercialization finish line?
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| FROM THE EDITOR |
Rita C. Peters
Emergency action to protect patients and the drug supply may have long-term implications.
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| US REGULATORY WATCH |
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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