Search results for " manufacturing"

Article Challenges in Analytical Method Development and Validation
BioPharm International spoke with Krumenaker, Krause, Guo, and Smith about the challenges involved in analytical method development and validation in biopharmaceutical manufacturing. Biopharmac…

Article Track-and-Trace Progress Benefits Supply-Chain Security Efforts
…ata electronically using electronic product code information services (EPCIS) to capture events from manufacturing to serialization [and] capping to shipping.EPCIS can capture those key events and sh…

Article Innovative Chromatography Resins Can Improve Purity and Quality
Ihre also notes that there continues to be strong demand for new mAbs to address new therapeutic areas and rising requests from customers of contract development and manufacturing organizations (CDMOs…

Article Regulatory Requirements for Safe and Efficient Biologic Drug Development
What are some key guidelines for biopharma companies to follow? Steven Lynn: I think, first off, it depends on where the company is manufacturing and marketing their products. From the US persp…

Article Automating the Biomanufacturing Process
Automation has traditionally focused on controlling the manufacturing process throughout production to ensure that product remains identical between batches. Control has been manifested mainly in mini…

Article Scaling Up Novel Therapies
The key to making gene therapy accessible to patients will be better manufacturing processes, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, told attendees at the Galien …

Article The Challenge of Disruptive Technologies in Bioprocessing
In addition, there is increased focus to expand the role of contract manufacturing organizations (CMOs) to meet market demands for biomanufacturing, Terova explains. “Higher productivity and hi…

Article Making the Move to Continuous Chromatography
In the clinical manufacturing setting, Levison notes that users are looking for more efficient use of the resin lifetime by cycling more frequently compared to batch. “Clinical manufacturers are motiv…

Article A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Similar cell-culture media may be used simultaneously in one or few biological processes at a drug product manufacturing facility. As per Code of Federal Regulations (CFR) 211. 84, each media needs to…

Article Selecting a Comprehensive Bioburden Reduction Plan
By Randi Hernandez There are multiple variables to consider in the reduction of bioburden, including the evaluation of microbes in a facility, in the manufacturing process, and in the materials us…

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