samedan logo
 
 
spacer
home > pmps > autumn 2021 > choosing a cdmo partner for your highly potent drug development to commercialisation journey
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Choosing a CDMO Partner for Your Highly Potent Drug Development to Commercialisation Journey



The importance of selecting the right partner for managing the development to commercialisation lifecycle of products containing HPAPIs cannot be underestimated. The safe handling of products classified as highly potent is growing in complexity along with the associated regulatory requirements, therefore, identifying and assessing a partner with the specialist capabilities to take a product through to commercial launch is of critical importance.

Some companies may work with multiple vendors during the clinical development to commercial cycle, whereas others choose to identify and work with one partner able to manage different stages of the process. Whichever path is taken, conducting full due diligence as part of the vendor selection process to ensure that a partner is able to meet all required criteria will be key to a successful project.

How do you assess risk and evaluate highly potent containment strategies or a potential partner?

Confusion in classification is the first obstacle to overcome. Organisations may use different terms when classifying HPAPIs: occupational exposure bands, occupational health categorisations, control bands, and some larger companies may use their own in-house classifications. Irrespective of what is used by the client company, it is essential that a transfer of all data is conducted to allow the chosen vendor to make an accurate assessment using their established criteria. A risk assessment framework is required in order to determine the probability of exposure based on a combination of occupational hygiene and containment procedures in place remembering that a risk assessment is not a one-off exercise, but something that needs to be monitored and repeated as additional data become available.



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
Dr Rebecca Coutts PhD graduated from the University of Bath with a Batchelor in Pharmacy before completing a PhD in Pharmaceutics from Cardiff University, Wales. Rebecca is also a registered member of the General Pharmaceutical Council. Over her 25-year career, Rebecca has shown a clear passion for development services and currently holds the role of General Manager for PCI Pharma Services at its Tredegar site, PCI’s centre of excellence for manufacturing services. Prior to this, Rebecca held roles including Director of Development for the site with specialist expertise in the development and processing of highly potent molecules, and Associate Director of Contained Manufacturing. Before joining PCI, Rebecca held multiple roles including; Head of Pharmaceutical Development for Vectura and Group Leader, Manufacturing, Science, and Technology Services at Abbott Laboratories.

Print this page
Send to a friend
Privacy statement
News and Press Releases

WuXi STA Forms Strategic Partnership with Coherent Biopharma

Shanghai, 1st December 2021: WuXi STA – a subsidiary of WuXi AppTec – and Coherent Biopharma, announced the signing of a strategic partnership agreement.
More info >>

White Papers

Is Your Biobank Ready for the Challenge of Biomarker-based Research?

BioFortis

Targeted and personalized studies with well-defined patient segmentation biomarkers are becoming the norm in clinical trials. This increased interest in molecular biomarker studies necessitates a rigor and sophistication in sample management within the clinical trial context that is often not supported either by traditional clinical trial management software (CTMS), or biobanking systems.  Download our Next Generation Biobanking whitepaper and learn about how to overcome the key challenges in clinical trial sample management from working in a distributed network of partners and stakeholder to managing consents and generating scientific insights.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement