Search results for " start" in Articles / App Notes
Article
Being Thorough When Transferring Technology
Other examples are unexpected low titer compared to process development runs or unexpected filter clogging in depth-filtration steps due to different quality of filtration starting material. An exampl…
Article
Lessons Learned Accelerate Vaccine Development
Frequently in the absence of such platforms, de novo development—or starting from scratch—of vaccines is necessary.
In addition, not all vaccine production methods can be applied for all vaccine p…
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Taking a “Development-by-Design” Approach to Cell Therapies
“The starting points can vary dramatically,” Grant says. He recalls one customer whose autologous process ran to $80,000 per patient in early stage clinical trials. Automation, he says, could reduce c…
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Securing the Single-Use Supply Chain
As a result, according to Tony White, a founding director of the BioPhorum Operations Group (BPOG), some biopharmaceutical manufacturers are now starting to consider single-use technologies as a strat…
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Report from the 12th Plasma Product Biotechnology Forum
In this case study a normal DoE approach was deemed too challenging due to the high number of different starting materials resulting in an extremely high number of experiments. Such limitations were e…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
For a multi-product downstream suite, Shave notes that it can be better to have the plant broken up into two or three segregated smaller rooms versus a single ballroom so changeover can start as soon …
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
…echnology and pharmaceuticals practice group, based in the United States; Daniel Rooke, partner with Start Codon in the United Kingdom; and Mathew Royle and Paul England, both partners with Taylor We…
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Supply Chain Challenges for Single-Use Systems
…ough to the finished components)?
Pora (Pall): The best way is to have quality built in from the start. There is always going to be a need to test the end product, but it is much easier if the qu…
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Leveraging Data for Better Biopharmaceutical Process Control
Biopharmaceutical companies are starting to use PAT in more advanced development and even some manufacturing work, while methods are also moving downstream. Francisca F. Gouveia, a biopharmaceutical p…
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A Bright Future for the Plasma Fractionation Industry
Day two of the PPB meeting started with the Pathogen safety session, chaired by Hannelore Willkommen. Three opening presentations dealt with the Hepatitis E Virus (HEV) issue from a risk, regulatory, …