Search results for " raw material characterization"
Article
QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
Article
Using Digital Twins to Model Process Chromatography
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.
By Jennifer Markarian
A digital twin is a model of a proces…
Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
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Process analytical technology (P…
Article
Use of Multivariate Data Analysis in Bioprocessing
…lture and chromatography, quantitative assessment of process comparability, root cause analysis, and raw material characterization (3, 4).
In this 33rd article in the “Elements of Biopharmaceutic…
Article
Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…
Article
Good Manufacturing Practices: Challenges with Compliance
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The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
…
Article
Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
Article
Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
By Rita C. Peters
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Article
Robust Optimization, Simulation, and Effective Design Space
Jul 01, 2015
By Thomas A. Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of …
Article
Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…