spacer
home > pmps > summer 2019 > a cold case
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

A Cold Case

Patient safety will always be the top priority of every clinical trial. Therefore, it is vital that the investigational medicine dispensed to the patient is pure, safe, and effective no matter what challenges are presented by packaging, storage, and distribution requirements.

Many medicines have a stringent stability profile, where the acceptable temperature range in which the drug must be stored and distributed is strictly dictated to ensure the product remains safe and effective. This is becoming the norm rather than the exception, with large molecules and biologic medicines now playing a more prominent role in clinical development. Therefore, ensuring the biologics are optimally safe and effective is often an issue of sustaining the product at very specific temperatures and maintaining these requisites despite what can be differing, and even extreme, environmental conditions.

To control the temperature conditions of the drug at every step in the supply chain, it is critical that trial sponsors consider a range of factors. From the point in time that the drug is first manufactured through to the end delivery to the patient, it will be exposed to a multitude of environments during its lifecycle. Stages of this will include initial packaging, storage at the distribution facility, clinical site transportation and storage, and distribution to the patient.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Brian Keesee, Vice President and General Manager of PCIís Global Clinical Operations and Supply, has spent his entire career in the pharma industry. In his current role, Brian is responsible for global clinical operations and project management, including PCIís stateof- the-art packaging and distribution facilities located in Rockford, US, and Bridgend, UK.
spacer
Brian Keesee
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

3P Biopharmaceuticals initiates partnership with American Biotech Zhittya for Parkinsonís disease treatment

3P and Zhittya began their relationship at the beginning of 2019 with 3P being selected as the CDMO to transfer the process for scaling up and performing cGMP manufacturing for clinical studies. After successfully achieving transfer of the process, 3P anticipates manufacturing of the first cGMP batch by the second quarter of 2020.
More info >>

White Papers

The EC Definition of a Nanomaterial - Potential Measurement Methodologies

NanoSight

In October 2011 the European Commission published a definition of Nanomaterials. This move followed more than six years of scientific consideration of the potential toxicological and environmental challenges posed by engineered nanomaterials.
More info >>

 
Industry Events

Clinical Trial Supply Europe

11-12 March 2020, Madrid, Spain

The 21st annual edition promises to grow on the success of 2019ís excellent conference which saw delegates from Europeís largest pharmaceutical companies and biotech innovators come together to discuss, debate and unpack the latest trends in clinical supply chain innovation. 2020 will offer delegates the opportunity to address the growing need for agility within the supply chain in response to increasingly complex trial demands. With a stream dedicated to supply operations and another to innovative uses of technology in the supply chain, delegates will get the chance to gain practical take-aways that they can apply to their own studies.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement