Search results for " industry 4.0"
Article
Reducing Cross-Contamination Risks in Process Chromatography
Reducing Cross-Contamination Risks in Process Chromatography
Single-use systems provide replaceable fluid paths.
By Cynthia A. Challener
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Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
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Article
Avoiding Investigational Failures and Discrepancies
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
By Walt Murray,…
Article
Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
By Cynthia Challener, PhD
Chromatography is a crucial step in the purif…
Article
Defining Risk Assessment of Aseptic Processes
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
By Susan J. Schniepp
Q: I work in …
Article
Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict.
By Randi Hernandez
Demand for any given new product is typically only known after significant investments h…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.
By Marcos Simon, Juan J. Giner-Casares
Cell…
Article
Antibody Production in Microbial Hosts
The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.
By Anurag S. Rathore, Jyot…
Article
Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…
Article
USP Stresses Pharmacopeial Standards at CPhI China
Jun 29, 2015
By BioPharm International Editors
The United States Pharmacopeial Convention (USP) hosted a pharmacopeial and regulatory compliance seminar at the 2015 CPhI China conference, he…