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Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

Article Finding Opportunities in Brazil
Feb 06, 2015 By Hellen Berger BioPharm International Volume 28, Issue 2 Brazil’s turbulent presidential election in October 2014 shed some light on the country’s political landscape …

Article Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain. Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…

Article Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design. Sep 1, 2014 By: Susan Haigney BioPharm International Volu…

Article Healthcare Reform in China
Chinese healthcare reforms may be a double-edged sword for foreign companies. Sep 1, 2014 By: Jane Wan BioPharm International Volume 27, Issue 9, pp. 8-12  On March 25, 2014, the…

Article The Affordable Care Act's Impact on Innovation in Biopharma
Government agencies are funding cost-effectiveness studies; payers and large providers are investing in health technology assessments and forming alliances to analyze real world data; and most informa…

Article Climate Change in Outsourcing
…ility to fulfill CTM requirements relatively quickly and at low cost while commercial-scale CMOs are investing in their development capabilities to satisfy post-POC demand for formulation and manufac…

Article Top Process Development Trends for 2022 and a Look into 2023
FDA approved 37 drugs in 2022, within the normal range for the past decade or so. The European Medicines Agency (EMA) was even more successful—approving a record 55 therapies. More than half of thes…

Article Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages. Cynthia A. Challener  Upstream viral-vector processes can have sig…

Article Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach. By Cynthia A. Ch…

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