Remy Martin, business development specialist at cell and gene therapy manufacturing consultant, eXmoor Pharma, discusses 10 key considerations when creating a manufacturing facility, to ensure it meets requirements for both immediate needs and future growth.
NEW ADVANCED therapy medicinal product (ATMP) manufacturing facilities represent significant capital investment. By taking an approach that addresses a facility’s production and output obligations, stakeholders can make informed decisions that will lead to a successful construction and long-term operation.
Are you looking to explore how lipid formulations in softgels can enhance drug absorption and bioavailability. Register for our upcoming webinar to find out!
3 September 2025 | 3:00 PM BST | FREE Webinar
This webinar will delve into the different types of lipid formulations, such as solutions, suspensions, emulsions, and self-(micro)emulsifying systems. Applications span diverse therapeutic areas including HIV therapy, oncology, immunosuppressants, and emerging treatments like medicinal cannabis (eg, CBD).
What You’ll Learn:
Lipid formulation development and screening tools for optimisation
Key steps in scale-up and industrialisation to ensure consistency and efficiency
Impact of lipid-based softgels on drug delivery and patient outcomes.
Can’t attend live? No worries – register to receive the recording post-event.
The following aspects should be assessed before a site is agreed, to reinforce the project’s long‑term success. While many of these are concurrent considerations, often one or more go under‑scrutinised during the planning process.
Considerations of area and capacity
The prospective site area should not merely be of suitable size for the manufacturing site, warehouse and laboratories; it is imperative to be forward thinking, considering office space, meeting rooms, reception areas and any other rooms or buildings that may be required. Examining all planned facility projects will give a good indication of the capacity required at the new site.
Allowances for air circulation spaces
In accordance with regulatory guidance, six to eight metres of space is required above the cleanrooms to include a walk-on ceiling, which will permit these areas to be serviced from the outside. Space will also need to be made available for suitable heating, ventilation and air conditioning (HVAC) throughout the manufacturing and office areas. If the selected building has sufficient height, the HVAC units could also be located above the cleanrooms themselves.
Vertical distribution
Isolated lifts must be included for the movement and distribution of supply materials, waste and the produced goods. The number of lifts will depend on the layout of the prospective building. An additional large goods lift must be installed to allow for the vertical transportation of motors and spares to the plantroom (should this be required). As mentioned earlier, a walk-on ceiling must be included above the cleanrooms to allow for servicing. Finally, you should allow for door heights of a minimum of 2.7 metres to enable free movement of large pieces of equipment throughout the key areas of the facility.
Flows
In the planning phase, it is important to evaluate whether there is a suitable flow and segregation of personnel, materials and waste. It is also vital to consider the number of lifts and required external docking stations.
Co-occupancy and access
Ideally, the site of choice should be single occupancy. Incoming or outgoing routes should not be shared with any other occupants. It should not be possible to mix materials, personnel, or waste routes within the facility. Unauthorised personnel should not be able to obtain access to the facility via stairwells or lifts.
Utilities
The following raw utility services will need to be supplied as standard to the facility: mains pressure water, both surface and foul drainage, natural gas (should this be required) and electrical power. Further consideration should be made, depending on the facility’s manufacturing process, for a second tier of utilities: water for injection, de-ionised water supply, pure steam, plant steam, process chilled water, clean-in-place (CIP) procedures and HVAC units to service cleanrooms.
Site and locality
Enough space should be allocated to avoid any margin for errors or cross contamination during quality checking and testing”
It is important to ensure there is sufficient space on-site for the following additional items: chiller compound, waste compound, gases and a dedicated liquid nitrogen (LN2) area. The generator compound must also be of sufficient size. Careful consideration on locality should be analysed and proximity to the following should be avoided during the planning phase: areas of standing water or falls in an area with a high flood risk, heavily polluted industrial air exhausts, and nearby large-scale construction sites. On principle, the manufacturing area should be at least one metre above the ground floor of the building.
Location
The location of a manufacturing facility is a crucial decision. It should be close to public transport links, amenities and in a safe working area. As first impressions are always important, the buildings and larger site should be smart and well maintained, portraying a professional and high‑quality image of the business.
Structural and loading requirements
In the manufacturing area there will be several large items of equipment that will impose a significant live loading on the floor. Therefore, there are minimum loading requirements in the office and general areas. The minimum requirement for live floor loadings is 2.5 kN/m2 above ground floor and 3.0 kN/m2 at ground level. In the manufacturing and plant areas, live loads need to be in accordance with the minimum standard (BS EN 1991-1-1:2002) of 7.5 kN/m2, ideally 10.0 kN/m2 to allow for a 1,000kg pallet (8.2 kN/m2).
Inventory and support areas
In warehouse areas, storage should be of sufficient capacity to allow various categories of materials and products to be stored in an orderly manner. Enough space should be allocated to avoid any margin for errors or cross contamination during quality checking and testing. As such, quality control laboratories should be kept separate from the production areas; rest and refreshment rooms should be kept separate from production, storage and quality control areas; and toilets and washrooms should not directly link with any production, storage, or quality control areas. Ensuring these factors are accounted for during the planning stage will pay dividends in the final facility.
About the author
Remy Martin is Operations Director at eXmoor Pharma Concepts Ltd. He has a PhD in Biochemistry, MBiol Molecular & Cellular Biology. Remy is a skilled business development specialist, with experience gained both in commercial and research environments. He has an extensive knowledge of cell culture, advanced therapies, bioprocessing, process control and upstream process development, which he utilises across a variety of interesting and innovative projects.
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.