In 2002, Novartis decided to create a new research centre in Cambridge, MA. This was accompanied by a significant increase in headcount in medicinal chemistry. Within two years, this resulted in a strongly increased demand for prep-scale synthesis which in turn led to priority issues and to prolonged turnaround times due to lack of resources in our Preparations Laboratories. In order to debottleneck time critical scale-up activities, the Preparations Laboratories was asked in 2004 to introduce outsourcing as an alternative option to an in-house increase of headcount…
In 2002, Novartis decided to create a new research centre in Cambridge, MA. This was accompanied by a significant increase in headcount in medicinal chemistry. Within two years, this resulted in a strongly increased demand for prep-scale synthesis which in turn led to priority issues and to prolonged turnaround times due to lack of resources in our Preparations Laboratories. In order to debottleneck time critical scale-up activities, the Preparations Laboratories was asked in 2004 to introduce outsourcing as an alternative option to an in-house increase of headcount.
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.
What you’ll discover:
Key trends shaping the pharmaceutical formulation sector
Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
Can’t attend live? No worries – register to receive the recording post-event.
Regarding the selection for outsourcing of projects, the following selection criteria should apply:
‘Easy’ projects with a good chance of success, i.e. well documented and few process steps
Shorter time for critical requests
Non-critical projects with regard to proprietary situation, giving us better control of quality and protection of know-how
In order to differentiate the individual com – panies from each other, the evaluation criteria outlined below were applied:
Response time, i.e. how fast did we get the quotation?
Costs per process step l Lead time: delivery date as agreed?
Quality: did the quality meet our expectations?
Quantity: target amount delivered?
Flexibility in case of issues, e.g. short time changes, troubleshooting, etc.
Collaboration, i.e. are the employees at their level competent in what they are doing, how is their availability, do they report well and properly and are they reliable?
Evaluation of outsourcing companies After choosing the selection and evaluation criteria, the evaluation process began. For this purpose, we invited outsourcing companies of interest to us. Finally, nine companies were selected according to the following profiles:
The geographic regions. Here the aim was to have these companies located in different countries because of strategic reasons
The reactor size, and often associated with that …
… the company size
The know-how / expertise and available technologies
With respect to the latter item, it was, for example, of special interest to know if the company had the know-how to prepare betaamino acids or to have access to ozonolysis methodology or up-to-date purification facilities and capabilities.
The evaluation strategy consisted of quotes from each company for at least four projects. Each project was to be quoted by at least two companies, and that company would perform at least two projects.
The results of the evaluation are shown in Figure 1.
As outlined, the evaluated companies were distributed over the three continents of Asia, America and Europe. It should be stressed that costs per process step was not the one and only evaluation parameter. We also took into consideration the discovery phase which was an even more important criterion to rate the individual companies. An interesting result worth mentioning was that the US based company was as competitive as Indian based companies. This also applied to the company from Slovakia. The other European based companies were in a price range of 6-9 KCHF per process step.
Selecting the preferred partners
After thorough analysis of the evaluation criteria including individual experiences made with the various companies during the project executions, the companies were selected to collaborate with as preferred external suppliers (see below).
With the exception of Company 4, all other companies exhibited high flexibility, a characteristic which is of utmost importance in the drug discovery phase. It also turned out that this company was not suitable for performing less complicated projects. However, this was the company to choose for placing more complex, larger scale requests because they had low prices and a good collaboration was experienced during the evaluation phase.
Another company that was chosen despite the fact that it had some weaknesses was Company 1, located in Switzerland. It had high average costs per process step, however this was compensated by the fact that the company was in close proximity to the location, thus enabling us to place high priority projects. In addition, the close vicinity allowed for ad hoc face to face meetings and discussions in case of troubleshooting etc.
Implementation of internal processes
In parallel to these more external related activities, internal ones also had to be executed in order to establish and speed-up the in-house processes required for a fast outsourcing. Meetings with the legal department were organised to set-up a master service and supply agreement which was finally signed by both parties. With the help and support of our finance group, a dedicated cost centre for the outsourcing activities was created. It enabled control over the budget at any time. Last but not least, an efficient workflow was established to streamline the internal process for ordering and administration. The flow chart outlined in Figure 3 exemplifies the internal process for placing and executing task orders.
Conclusion and outlook
To summarise, five companies were identified with whom collaborations were entered. The implementation of an internal workflow to speed-up the ordering process was very helpful and extremely beneficial.
Following a reflection of author’s own experiences, there is a feeling that the workload associated with outsourcing is being underestimated. Asking for quotations and placing the order is not the one and only activity to be carried out, especially in the drug discovery phase. Issues always arise and at any stage of the request, be it in terms of the synthesis or during the purification or any other non-chemistry related issue. They have to be discussed and to be solved. Therefore, it is very, very important to keep close contact with the individual preferred external suppliers. This paves the way to mutual trust and an excellent collaboration. Whenever possible, the preferred external suppliers should be visited. Experiences have shown that this creates, in addition to mutual trust, mutual respect and appreciation.
The evaluation of external partners is and will always be a continuous process. At the very beginning of the evaluation, nobody realised how much effort it would take to establish this business from scratch. Now there is gratifying satisfaction to have this business in place, not only because outsourcing enables us to have high flexibility, but also because this business has become an integral part of the Preparations Laboratories activities expanding the lab heads activity beyond his/her own lab and communicating with the world. This brings, as well as an additional workload, a lot of satisfaction.
Acknowledgement
The author would like to thank all colleagues involved in this evaluation. Special thanks go to Constanze Hartwieg, Hansjoerg Lehmann and Thomas Leutert for their huge efforts and dedication to this evaluation which otherwise it would not have been possible.
About the author
Luigi La Vecchia carried out his PhD 1989 at the University of Saarbruecken, Germany. Currently, he is Head of the Preparations Laboratories of the Novartis Institute of Biomedical Sciences where the outsourcing of building blocks and other chemical matters is an integral part of the business.
This website uses cookies to enable, optimise and analyse site operations, as well as to provide personalised content and allow you to connect to social media. By clicking "I agree" you consent to the use of cookies for non-essential functions and the related processing of personal data. You can adjust your cookie and associated data processing preferences at any time via our "Cookie Settings". Please view our Cookie Policy to learn more about the use of cookies on our website.
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorised as ”Necessary” are stored on your browser as they are as essential for the working of basic functionalities of the website. For our other types of cookies “Advertising & Targeting”, “Analytics” and “Performance”, these help us analyse and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these different types of cookies. But opting out of some of these cookies may have an effect on your browsing experience. You can adjust the available sliders to ‘Enabled’ or ‘Disabled’, then click ‘Save and Accept’. View our Cookie Policy page.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Cookie
Description
cookielawinfo-checkbox-advertising-targeting
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Advertising & Targeting".
cookielawinfo-checkbox-analytics
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Analytics".
cookielawinfo-checkbox-necessary
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Performance".
PHPSESSID
This cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.
viewed_cookie_policy
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
zmember_logged
This session cookie is served by our membership/subscription system and controls whether you are able to see content which is only available to logged in users.
Performance cookies are includes cookies that deliver enhanced functionalities of the website, such as caching. These cookies do not store any personal information.
Cookie
Description
cf_ob_info
This cookie is set by Cloudflare content delivery network and, in conjunction with the cookie 'cf_use_ob', is used to determine whether it should continue serving “Always Online” until the cookie expires.
cf_use_ob
This cookie is set by Cloudflare content delivery network and is used to determine whether it should continue serving “Always Online” until the cookie expires.
free_subscription_only
This session cookie is served by our membership/subscription system and controls which types of content you are able to access.
ls_smartpush
This cookie is set by Litespeed Server and allows the server to store settings to help improve performance of the site.
one_signal_sdk_db
This cookie is set by OneSignal push notifications and is used for storing user preferences in connection with their notification permission status.
YSC
This cookie is set by Youtube and is used to track the views of embedded videos.
Analytics cookies collect information about your use of the content, and in combination with previously collected information, are used to measure, understand, and report on your usage of this website.
Cookie
Description
bcookie
This cookie is set by LinkedIn. The purpose of the cookie is to enable LinkedIn functionalities on the page.
GPS
This cookie is set by YouTube and registers a unique ID for tracking users based on their geographical location
lang
This cookie is set by LinkedIn and is used to store the language preferences of a user to serve up content in that stored language the next time user visit the website.
lidc
This cookie is set by LinkedIn and used for routing.
lissc
This cookie is set by LinkedIn share Buttons and ad tags.
vuid
We embed videos from our official Vimeo channel. When you press play, Vimeo will drop third party cookies to enable the video to play and to see how long a viewer has watched the video. This cookie does not track individuals.
wow.anonymousId
This cookie is set by Spotler and tracks an anonymous visitor ID.
wow.schedule
This cookie is set by Spotler and enables it to track the Load Balance Session Queue.
wow.session
This cookie is set by Spotler to track the Internet Information Services (IIS) session state.
wow.utmvalues
This cookie is set by Spotler and stores the UTM values for the session. UTM values are specific text strings that are appended to URLs that allow Communigator to track the URLs and the UTM values when they get clicked on.
_ga
This cookie is set by Google Analytics and is used to calculate visitor, session, campaign data and keep track of site usage for the site's analytics report. It stores information anonymously and assign a randomly generated number to identify unique visitors.
_gat
This cookies is set by Google Universal Analytics to throttle the request rate to limit the collection of data on high traffic sites.
_gid
This cookie is set by Google Analytics and is used to store information of how visitors use a website and helps in creating an analytics report of how the website is doing. The data collected including the number visitors, the source where they have come from, and the pages visited in an anonymous form.
Advertising and targeting cookies help us provide our visitors with relevant ads and marketing campaigns.
Cookie
Description
advanced_ads_browser_width
This cookie is set by Advanced Ads and measures the browser width.
advanced_ads_page_impressions
This cookie is set by Advanced Ads and measures the number of previous page impressions.
advanced_ads_pro_server_info
This cookie is set by Advanced Ads and sets geo-location, user role and user capabilities. It is used by cache busting in Advanced Ads Pro when the appropriate visitor conditions are used.
advanced_ads_pro_visitor_referrer
This cookie is set by Advanced Ads and sets the referrer URL.
bscookie
This cookie is a browser ID cookie set by LinkedIn share Buttons and ad tags.
IDE
This cookie is set by Google DoubleClick and stores information about how the user uses the website and any other advertisement before visiting the website. This is used to present users with ads that are relevant to them according to the user profile.
li_sugr
This cookie is set by LinkedIn and is used for tracking.
UserMatchHistory
This cookie is set by Linkedin and is used to track visitors on multiple websites, in order to present relevant advertisement based on the visitor's preferences.
VISITOR_INFO1_LIVE
This cookie is set by YouTube. Used to track the information of the embedded YouTube videos on a website.