Search results for " continuous manufacturing" in Articles / App Notes
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…
Article
Technologies and Practices Must Evolve to Meet Demand
Continuous advancement
The survey responses reveal that continuous manufacturing currently is not used widely, but bioprocessing experts surveyed are optimistic about its future use. Less than one…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
Article
Quality Systems Key to Lifecycle Drug Management
Jun 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 6
The submission and review of manufacturing supplements is costly and time consuming for biopharmaceutical comp…
Article
Remote Monitoring and Big Data Advance Upstream Automation
Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming.
By Cynthia A. Challener
As upstream processing drives toward higher efficiencies in meeti…