Search results for "Tech transfer"
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
Article
Science Focus Fuels Successful Process Development for Startups
“What we learned while carrying out tech transfer, scaling up the process, and manufacturing over 300 autologous clinical batches that were then delivered to close to 10 countries served as a basis fo…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
Managing Biomanufacturing Capacity Expectations
“Either the manufacturing process was not as robust as the sponsor thought it was, or the tech transfer failed to successfully convey all subtleties to the contract manufacturing organization [CMO].” …
Article
Implementing QbD in Sterile Manufacturing
A day-to-day business example to showcase the improvement of tech transfer through QbD for customers is by demonstrating the lyophilization cycle development of a customer’s product. For example, by u…
Article
Process Development: What May Lie Ahead in 2018?
…ct of Media Components on CQAs of Monoclonal Antibodies
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Start with the End in Mind GMP Tech Transfer
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Avoiding Investigational Failures and Discrepancies
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High Throu…
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Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.
By Cynthia A. Challener
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Article
A Plastic Pipeline for Commercial Bioprocessing?
A single-use approach allows small companies that have one molecule to get into production with a lower capital investment, says Ben Hughes, global director, tech transfer, pharma services, Patheon, a…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…
Article
Modular Manufacturing Platforms for Biologics
May 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 5
It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…