spacer
home > pmps > spring 2007 > a stabilised position
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

A Stabilised Position

Sarah Gash at Bodycote Cirrus (part of Bodycote Health Sciences), investigates why outsourcing stability testing and storage makes sound business sense

Today, outsourcing parts of the analytical laboratory or manufacturing requirements to an independent laboratory is normal practice for most pharmaceutical companies both large and small. While there is often inertia when changing from inhouse to outsourcing of any work, in the longer term it makes good business sense – especially the deciding point.

With the rise of virtual pharmaceutical companies, it is perfectly possible to outsource almost everything and still deliver a quality product. Although companies worry that the risk to confidentiality and quality assurance may be increased, it is possible to manage this sensibly. Stability storage and testing is one area of work where volumes are increasing, and where it makes excellent sense to outsource. Outsourcing basic tasks such as stability testing can free up scientists to work on projects that will reap a better return, as well as resulting in more effective use of in-house lab space.

QUALITY ISSUES

Deciding whether to outsource stability testing, and indeed which laboratory to choose, involves looking at quality issues (especially in pharmaceutical analysis), service levels and monetary value (the price versus benefits to the business). So what makes stability testing and storage such an ideal area of business to outsource to an independent laboratory? And what distinguishes ‘stability’ from other testing which could potentially be outsourced?

Outsourcing Doesn’t Hold up Product Delivery
The reason is that stability studies for a finished product merely support the supply chain – they do not stop a product being loaded onto a lorry for market. This means that analysis does not have an impact upon the delivery of product to market, an essential for every commercial pharmaceutical manufacturer.

Outsourcing Helps Quicken the Development Process
For R&D stability, there are often huge peaks and troughs in workload. With the urgent need to get the work done, it doesn’t necessarily make sense to carry all this resource in-house. Using reliable partners to cover peaks of work helps get the product through the development process much more quickly.

Outsourcing Can be Cheaper
Stability storage and protocol testing is expensive and timeconsuming. When a manufacturer actually takes all its costs into account, it can often be cheaper to outsource to a specialist provider who can spread costs across various contracts. Outsourcing reduces costs because outside contractors focus on the specific services they provide and maintain a more costefficient business model as a result.


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.

 You must be a member of the site to make a comment.
spacer
A Chemistry graduate from the University of Birmingham, Sarah Gash has more than 14 years’ experience in a wide range of analytical roles within the pharmaceutical service industry. She has a thorough understanding of analytical method transfer and method validation for a variety of formulated pharmaceutical products, combined with expertise in many analytical techniques. Sarah has written and overseen report generation for regulatory submission for top 10 pharmaceutical companies, as well as smaller concerns. Having worked in the pharmaceutical sector throughout her career, Sarah has been involved in numerous audits, including ones by the FDA and MHRA, resulting in approval for the site.
spacer
Sarah Gash
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

AirBridgeCargo expands its passive pharma solutions in partnership with SkyCell as it achieves the two-fold volume increase

AirBridgeCargo expands its passive pharma solutions in partnership with SkyCell as it achieves the two-fold volume increase AirBridgeCargo Airlines (ABC), one of the leaders in transportation of pharmaceutical products by air, and Zurich-based cold-chain ULD manufacturer SkyCell have sealed their partnership for the lease of all types of SkyCell containers to meet the demand for evolving volumes of passive pharmaceutical shipments, which reached around 3,500 tonnes for 1Q 2019 YOY and demonstrated a two-fold increase.
More info >>

White Papers

The Flexible Factory Concept: A flexible bioprocessing platform to meet the changing needs of biomanufacturing

GE Healthcare Life Sciences

For the past several years, the biopharma industry has been buffeted by dynamic market conditions that are rapidly reshaping manufacturing requirements. These factors include: • The rise of small-market pharmaceuticals that do not require the production scale of the previous “blockbuster” drug model • Increased titers and process productivity that generate more bulk-product within a much smaller manufacturing footprint • The emergence of biosimilars and continued evolution of healthcare reform, which will increasingly pressure drug pricing and require greater cost discipline • Greater competition and shorter patent protection timelines, which will further ratchet up time-to-market pressures • Tighter capital markets that will create heightened scrutiny for all new investment projects
More info >>

 
Industry Events

DIA 2019 Global Annual Meeting

23-27 June 2019, San Diego Convention Center

DIA 2019 is more than just a meeting: it’s where brilliant minds come together to create solutions. Thousands of global innovators will convene to engage in discussions on today’s hottest topics in the life sciences field, propose ways to combat daily challenges, and network to create lasting connections.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement