Search results for "manufacturing" in Articles / App Notes
Article
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…
Article
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 …
Article
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, …
Article
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…
Article
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…
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Application of Quality by Design to Viral Safety
Using this approach, products are developed with a thorough understanding of how the raw materials and manufacturing processes impact the eventual clinical performance of the final drug product. QbD f…
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Tools and Processes for Mature and Emerging Therapies
Notable announcements include the application of artificial intelligence to control manufacturing processes, track raw materials, and troubleshoot equipment and process problems via a virtual system. …
Article
Drug Quality Key to Innovation and Access
Manufacturing challenges
Accelerated FDA approval of important therapies demands drug manufacturing systems able to scale up production quickly and efficiently and to maintain quality throughout th…
Article
Efforts Accelerate to Streamline Postapproval Change Process
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine after a drug comes to market to improve products and systems and ensure reliable supply of hig…