Search results for " process validation"

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
With the most recent FDA (1) and Inter-national Conference on Har-monization (ICH) guidances (2-4) advocating a new paradigm of process validation based on process understanding and control of paramet…

Article The Lifecycle Change of Process Validation and Analytical Testing
BioPharm International spoke with Hal Baseman, COO and principal at ValSource LLC and co-leader of the Parenteral Drug Association Process Validation Interest Group; Paul Smith, EMEAI laboratory compl…

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 Mapping a Route for Cell and Gene Therapy Process Development
Common validation hurdles One of the primary requirements for process validation is to demonstrate documented evidence that the scaled process can consistently produce the final product, meeting t…

Article Economic drivers and trade-offs in antibody purification processes
The future of therapeutic MAbs lies in the development of economically feasible downstream processes.  By Suzanne S. Farid, PhD  ABSTRACT Increasing titers in mammalian cell culture has rec…

Article Continued Process Verification for Biopharma Manufacturing
Guidance issued by FDA in 2011 (1) emphasized the importance of manufacturers undertaking CPV as an integral part of the process validation lifecycle. CPV will provide the manufacturer with assurance …

Article Purification Strategies to Process 5 g/L Titers of Monoclonal Antibodies
Altering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facility changes. By Melody Trexler-Schmidt, Stefanie Sze-Khoo, Amber R…

Article Achieving Process Balance with Perfusion Bioreactors
Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run. By Cynthia A. Challener  MG/Stock.Adobe.com …

Article Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes. By Susan Haigney natali_mis/Stock.Adobe.com Regulators have been encourag…

Article Using Software in Process Validation
By Robert Glaser Within pharmaceutical manufacturing, the goal of process validation is to build quality into the operation at every step to ensure consistent product quality. It seems straig…

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