Search results for "manufacturing"
Article
The Lifecycle Change of Process Validation and Analytical Testing
I think material understanding throughout the manufacturing process from the product development phase onwards will not only support a robust commercial manufacturing process but can also reduce the b…
Article
Setting Up Bioprocessing Systems for Digital Transformation
By Feliza Mirasol
The advancement of digitalization technologies is transforming manufacturing processes and operations in the biopharmaceutical industry. Bioprocessing is no exception, as the ind…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
… online), enabling automated and continuous process control—sometimes thought of as “lights out manufacturing.” The enabling real-time analytical solutions may be based on established and validated t…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
…therapies progressing toward regulatory review, there is increased focus on establishing commercial manufacturing facilities for these complex biotherapeutics. The workflows of a cell therapy or a ge…
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QbD and PAT in Upstream and Downstream Processing
Vanden Boom, PhD, vice-president, global biologics research, development and manufacturing operations, Hospira.
UPSTREAM PROCESSING
BioPharm: In implementing QbD, what would you i…
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Biomanufacturing: Demand for Continuous Bioprocessing Increasing
The classic and still predominant approach to bioprocessing, both upstream and downstream, remains batch processing, with manufacturing batch fluids essentially moving incrementally en-masse from one …
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Manufacturing change validation/product comparability studies:Necessary to re-validate process with starting material that is essentially indistinguishable from original material in terms of quality, …
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Speed and Flexibility Are Dual Goals for Biopharma Operations
What trends did the BioPharm International editorial team observe about manufacturing facilities and operations?
As demand for biologics drug manufacturing increases capacity, contract manufacture…
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Cleaning of Dedicated Equipment: Why Validation is Needed
This article covers cleaning validation of equipment dedicated to the production of a single API; equipment used for manufacturing a class of products (e.g., penicillins) should be considered as share…
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Securing the Single-Use Supply Chain
As confidence in the technology has increased, the adoption of disposable equipment for commercial manufacturing has begun to take place. With this shift has come a dependence on suppliers that is rel…