BioPharm International
March 02, 2020
Cover Story: Upstream Processing
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Better understanding and control of cell behavior is yielding benefits, upstream and beyond.
March 02, 2020
Upstream Processing
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The future of raw material sourcing for mAb production may lay in the sustainability of the source and the added benefits of newer technologies.
March 02, 2020
Downstream Processing
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Ensuring the quality of data in process monitoring and control systems starts in process development phases.
March 02, 2020
Manufacturing
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Single-use and modular systems will meet demand for rapid implementation at different scales.
March 02, 2020
Analytics
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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.
March 02, 2020
Quality/Regulations
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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.
March 01, 2020
BioBusiness
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As patent disputes within the scientific community continue, drug developers consider the intellectual property unknowns associated with this emerging technology.
March 01, 2020
Outsourcing
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Contract service organizations can offer biopharma companies early insight into dangers that may hinder a drug’s later development.
March 01, 2020
Regulatory Beat
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States, hospitals, and insurers support manufacturing arrangements to ensure access to affordable medicines.
March 01, 2020
From the Editor
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Emergency actions to protect patients and the drug supply may have long-term implications.
March 01, 2020
Ask the Expert
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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.
March 01, 2020
Issue PDF
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Click the title above to open the BioPharm International March 2020 issue in an interactive PDF format.