Search results for " continuous manufacturing"
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
…nd evaluation of novel and improved manufacturing methods to improve product quality, namely through continuous manufacturing, novel manufacturing technologies, excipients and complex dosage forms, a…
Article
Perfusion in the 21st Century
Regulatory agency interest in the greater process control and product consistency afforded by continuous manufacturing (8) is also generating more attention around perfusion technology.
As perfusi…
Article
Bioprocessing Advances in Vaccine Manufacture
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
The vaccine industry, particularly, in major Western markets, continues to be dominated by a few majo…
Article
Digitalization: The Route to Biopharma 4.0
In a case study, it was seen that integrating a distributed control system with the sensors and control elements provided a means to implement QbD and PAT in continuous manufacturing (12). In addition…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches.
By Cynthia A. Challener
For a vaccine to be effective, the components of the disease o…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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Article
Biopharma Advances Demand Specialized Expertise
BioPharm: What are the prospects for continuous manufacturing to be firmly established in bioprocessing? What are the roadblocks to implementation?
Lorimer (Patheon Biologics): Continuous productio…
Article
Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Iss…