Biomanufacturing White Papers and Case Studies
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The Science Of Cell Therapy Thawing
4/5/2021
A summary of the science of thawing following conventional slow freezing methods, the physical and biological implications of key metrics and components, and key studies from scientific literature.
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Bringing The Freezing Of Biopharmaceuticals In From The Cold
3/18/2021
In this paper, we review end-to-end freezing solutions that integrate bulk filling, storage, shipping, thawing, and fill-finish operations to minimize risk and preserve product quality.
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Freezing & Storing Biopharmaceuticals At -80° C And Below
2/24/2021
There are many choices for freezing biopharmaceutical bulk material. This paper demonstrates that the initial price can be deceiving and the significant additional costs during ongoing usage.
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Managing Complex Global Drug Distribution And Expiry
1/12/2021
A global top-ten pharma company sponsored a complex, 8-year Phase III trial across 43 countries. As costs mounted and supplies waned, it realized the trial could be better managed if outsourced.
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Reducing Risk, Spending, And Workload In A Global Diabetes Trial
10/29/2020
A sound ancillary management strategy requires a clear understanding of a study’s design and end-to-end requirements, in-depth knowledge of international regulations, and rigorous proactive planning.
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Delivering Clinical Trial Medications Direct-To-Patient
10/15/2020
In recent years, the direct-to-patient model, which brings medical procedures to a patient’s home, has emerged as a solution for sponsors to increase patient recruitment and retention in clinical trials.
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Low Risk Frozen Distribution Of Single-Use Bags For Bioprocessing
9/21/2020
This paper will discuss the results of applying an approach using sensors and more suitable material to a frozen shipping study of single-use fluoropolymer bags.
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Save Space With Single-Use Bags, Secondary Packaging Solution
8/20/2020
Find out how a multinational biopharma company overcame a diminished shipping capacity challenge after switching to single-use bags to improve storage capacity at one of its production sites.
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How To Select The Best Courier Around The Globe
6/15/2020
As a leading biotechnology company's pipeline and global presence continued to grow, management of the supply chain presented challenges. Additionally, cost pressures demanded a tighter supply chain with better control over inventory levels, and there was a need for increased temperature monitoring of clinical supplies in transit. Learn how data-driven decisions allowed them to realize cost & performance improvements across the supply chain.
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Early Licensure Of A Breakthrough Cancer Drug Gives Hope To Patients
6/15/2020
No clinical supply request could be a higher priority than that of a physician urgently seeking an investigational cancer drug for a patient who has exhausted all treatment options.