ATMP Facility Design: Best Practices for Building a Multi-Product Manufacturing
Building a facility for advanced therapy medicinal products (ATMPs) is one of the most complex undertakings in pharmaceutical manufacturing. These facilities produce gene therapies, cell therapies, and other biologics that treat rare and ultra-rare diseases, often for patients with no alternative options.
The stakes are high. Design errors not only increase costs but can also delay life-saving treatments by years. Success requires more than just technical skill; it demands disciplined decision-making throughout design, construction, and operations. This guidance is grounded in Andelyn’s direct experience designing and building the Andelyn Commercial Center, a multi-product ATMP facility in Columbus, Ohio.
4 Competencies Required for a Successful ATMP Facility Project
The organizational structure of the project team is often the single greatest predictor of success or failure. High-performing ATMP facility projects are built around four core competencies, each with a distinct role in decision-making and execution:
- A seasoned facility leader (Owner) who can contribute valuable operational insights starting in the design phase of the project, all the way through to startup and turnover.
- A/E and Construction Management teams with experience in similar designs and builds.
- Project Executive leadership (Owner) with a pharma background to align the facility with long-term business and regulatory needs.
- Process experts (Owner side) who understand the manufacturing workflows that the ATMP facility must support.
Turning the Right Team into the Right Outcomes
Having the right team is essential, but not enough. How that team functions during design and construction ultimately influences the project's success. Three key practices consistently distinguish successful projects from troubled ones.
- Onboard an experienced facility leader early in the design phase, not after critical decisions have been locked in.
- Establish a formal change-order process from day one. Verbal agreements create ambiguity and risk.
- Vet your A/E and construction management teams for pharma-specific experience. Companies may have appropriate experience, but if the project team is lacking, the Owner must step up to fill the void.
Even with strong leadership and clear processes, execution risks often emerge at the interfaces between scopes. Specialty contractors may perform well within their domains, but gaps frequently appear where responsibilities intersect. The transition from wall to floor, from Vendor A to Vendor B, demands active CM oversight and is precisely where problems can hide.
HVAC: The Single Biggest Design Decision for ATMP Facilities
For a multi-product ATMP facility, HVAC design is the most consequential technical choice. The HVAC system is the foundation upon which your manufacturing house is built. The decisions made here directly impact contamination control, operational flexibility, and long-term cost structure. Some considerations:
· Single pass vs. recirculated air. Single-pass air handlers that supply 100% fresh air are a major advantage for cross-contamination control. The trade-off is higher utility and capital costs, but for any multi-product operation, the investment pays for itself in regulatory confidence and client trust.
· Dedicated vs. shared air handlers. Shared units are acceptable if the air is single-pass. Dedicated handlers offer maximum flexibility for rolling maintenance shutdowns without impacting neighboring suites, at the cost of higher capital and maintenance spend.
· Pressurization schemes. Both cascade and sink strategies have valid applications within a single facility. Match the approach to the contamination control strategy required for each area.
Commissioning vs. Qualification: Decide Before You Buy
Clarity around which systems will be commissioned versus formally qualified before procurement and fabrication begins is necessary. Retrospective qualification can be difficult and expensive, and it introduces risk to the project timeline. Define the boundaries clearly, document the rationale, and ensure alignment between the engineering and quality teams before issuing the first purchase order.
N+1 Redundancy: Where It Adds Value and Where It Doesn’t
Not all systems require redundancy, and overapplying N+1 design can quickly inflate capital costs without meaningful operational benefit. A targeted, risk-based approach delivers better outcomes.
· Where redundancy may not be justified: Compressed gas distribution systems andhumidification steam boilers often do not warrant backup units; evaluate theactual operational impact of routine maintenance work before committing capitalto a backup.
· Where redundancy proves its worth: Redundant supply and return fans in every AHU consistently deliver value. A fan failure in a GMP environment cascades through the entire production schedule, and the modest cost of backup fans is easily justified.
· Don’t overlook sequencing. The choice between lead/lag operation and both fans running at 50% affects energy consumption, wear patterns, and failover behavior. Do not let your controls contractor’s default assumption make this decision.
Utility Planning: Start Lean, Plan for Expansion
Utility infrastructure should reflect current needs without limiting future growth. Designing with expansion in mind avoids costly retrofits and operational disruption later.
· Gas supply. Start with cylinders and dewars rather than bulk storage tanks, but reserve the footprint for future tank installation.
· Electrical supply. Size for full design operations and negotiate upfront with the local utility for a clear expansion pathway.
· Process chilled water. ATMP process loads are generally much smaller than HVAC loads. Consider a separate temperature-controlled loop fed from HVAC chillers rather than dedicated process chillers that sit underutilized. Redirect the savings toward a backup HVAC chiller.
Deferred Decisions Don’t Disappear. They Compound.
Deferring scope can help manage capital, but unresolved decisions often resurface later, with increased complexity and cost. The goal is to defer intentionally while maintaining future flexibility.
· Water for Injection (WFI): Purchasing WFI rather than installing on-site generation avoids upfront capital. If you defer the full install, consider installing distribution drops in every cleanroom during the base project construction to minimize future disruption. But be honest about what remains unresolved: an unfinalized automation strategy and incomplete validation documentation may require rework when the system is eventually commissioned.
· Emergency Power: Placing AHU fans on emergency generators with UPS controls is standard, but excluding HVAC chillers from emergency power is a big mistake. One does not work without the other (for very long). Use intelligent breakers to add and shed loads as needed, and carefully consider what should be on emergency power from the outset.
· Amenity Spaces: Even employee cafeterias benefit from forward-thinking infrastructure. Build plumbing, electrical, and ventilation to support future expansion; the incremental cost during construction is minimal compared to a retrofit.
6 Operational Lessons from ATMP Facility Experience
Day-to-day operations often reveal issues that are not obvious during design. These lessons reflect practical realities that can significantly impact reliability, maintenance, and compliance.
1. Maintenance access is very important. While LED fixtures can last 20 years, their drivers may not. Be sure not to route conduit over access panels for ceiling light fixtures. Doing so magnifies the complexity of simple maintenance tasks. Ensure maintenance access is considered for every installed component, not just the ones that are obviously serviceable.
2. AHU air intakes may have screens that can clog rapidly during pollen seasons and snowstorms. Plan for this with relief dampers, differential pressure alarms, or frequent cleaning schedules. Learning this operationally means risking cleanroom pressure excursions.
3. Concealed sprinkler heads in cleanrooms may use gasket materials that are incompatible with cleaning chemicals. Choose an appropriate device (check the fine print) or plan for replacement every 6–12 months.
4. Equipment movement between suites must be planned from the start in modular cleanroom configurations. Think through compliant relocation pathways, sterilizer placement, and the entry of sterile components into production areas.
5. Start-up checks deserve the same rigor as process validation. Generator sensitivity settings, transformer tap settings, switchgear testing, and duct leak testing should all be defined during design, not improvised during commissioning.
6. All underground piping should be visually inspected before pouring the floor slabs. Backfilling mistakes can happen, and repair costs (dollars and schedule) will be impactful.
Build, Protect, Start Up Your ATMP Facility
As elements are installed, ensure they are protected from the remaining work. This should be standard operation for bioprocess facility projects. Building an ATMP facility is a years-long commitment with consequences that can extend for decades. Every decision, from HVAC strategy to utility planning to what gets deferred, shapes operational performance, regulatory outcomes, and ultimately patient access.
The most successful projects share a common trait: they view design, construction, and start-up as an ongoing quality process rather than a series of handoffs. Addressing these details early is not just good project management; it is crucial to delivering therapies to patients who cannot afford delays.
Talk to our experts about best practices for ATMP facility design, construction, and operations.
Building a facility for advanced therapy medicinal products (ATMPs) is one of the most complex undertakings in pharmaceutical manufacturing. These facilities produce gene therapies, cell therapies, and other biologics that treat rare and ultra-rare diseases, often for patients with no alternative options.
The stakes are high. Design errors not only increase costs but can also delay life-saving treatments by years. Success requires more than just technical skill; it demands disciplined decision-making throughout design, construction, and operations. This guidance is grounded in Andelyn’s direct experience designing and building the Andelyn Commercial Center, a multi-product ATMP facility in Columbus, Ohio.
4 Competencies Required for a Successful ATMP Facility Project
The organizational structure of the project team is often the single greatest predictor of success or failure. High-performing ATMP facility projects are built around four core competencies, each with a distinct role in decision-making and execution:
- A seasoned facility leader (Owner) who can contribute valuable operational insights starting in the design phase of the project, all the way through to startup and turnover.
- A/E and Construction Management teams with experience in similar designs and builds.
- Project Executive leadership (Owner) with a pharma background to align the facility with long-term business and regulatory needs.
- Process experts (Owner side) who understand the manufacturing workflows that the ATMP facility must support.
Turning the Right Team into the Right Outcomes
Having the right team is essential, but not enough. How that team functions during design and construction ultimately influences the project's success. Three key practices consistently distinguish successful projects from troubled ones.
- Onboard an experienced facility leader early in the design phase, not after critical decisions have been locked in.
- Establish a formal change-order process from day one. Verbal agreements create ambiguity and risk.
- Vet your A/E and construction management teams for pharma-specific experience. Companies may have appropriate experience, but if the project team is lacking, the Owner must step up to fill the void.
Even with strong leadership and clear processes, execution risks often emerge at the interfaces between scopes. Specialty contractors may perform well within their domains, but gaps frequently appear where responsibilities intersect. The transition from wall to floor, from Vendor A to Vendor B, demands active CM oversight and is precisely where problems can hide.
HVAC: The Single Biggest Design Decision for ATMP Facilities
For a multi-product ATMP facility, HVAC design is the most consequential technical choice. The HVAC system is the foundation upon which your manufacturing house is built. The decisions made here directly impact contamination control, operational flexibility, and long-term cost structure. Some considerations:
· Single pass vs. recirculated air. Single-pass air handlers that supply 100% fresh air are a major advantage for cross-contamination control. The trade-off is higher utility and capital costs, but for any multi-product operation, the investment pays for itself in regulatory confidence and client trust.
· Dedicated vs. shared air handlers. Shared units are acceptable if the air is single-pass. Dedicated handlers offer maximum flexibility for rolling maintenance shutdowns without impacting neighboring suites, at the cost of higher capital and maintenance spend.
· Pressurization schemes. Both cascade and sink strategies have valid applications within a single facility. Match the approach to the contamination control strategy required for each area.
Commissioning vs. Qualification: Decide Before You Buy
Clarity around which systems will be commissioned versus formally qualified before procurement and fabrication begins is necessary. Retrospective qualification can be difficult and expensive, and it introduces risk to the project timeline. Define the boundaries clearly, document the rationale, and ensure alignment between the engineering and quality teams before issuing the first purchase order.
N+1 Redundancy: Where It Adds Value and Where It Doesn’t
Not all systems require redundancy, and overapplying N+1 design can quickly inflate capital costs without meaningful operational benefit. A targeted, risk-based approach delivers better outcomes.
· Where redundancy may not be justified: Compressed gas distribution systems andhumidification steam boilers often do not warrant backup units; evaluate theactual operational impact of routine maintenance work before committing capitalto a backup.
· Where redundancy proves its worth: Redundant supply and return fans in every AHU consistently deliver value. A fan failure in a GMP environment cascades through the entire production schedule, and the modest cost of backup fans is easily justified.
· Don’t overlook sequencing. The choice between lead/lag operation and both fans running at 50% affects energy consumption, wear patterns, and failover behavior. Do not let your controls contractor’s default assumption make this decision.
Utility Planning: Start Lean, Plan for Expansion
Utility infrastructure should reflect current needs without limiting future growth. Designing with expansion in mind avoids costly retrofits and operational disruption later.
· Gas supply. Start with cylinders and dewars rather than bulk storage tanks, but reserve the footprint for future tank installation.
· Electrical supply. Size for full design operations and negotiate upfront with the local utility for a clear expansion pathway.
· Process chilled water. ATMP process loads are generally much smaller than HVAC loads. Consider a separate temperature-controlled loop fed from HVAC chillers rather than dedicated process chillers that sit underutilized. Redirect the savings toward a backup HVAC chiller.
Deferred Decisions Don’t Disappear. They Compound.
Deferring scope can help manage capital, but unresolved decisions often resurface later, with increased complexity and cost. The goal is to defer intentionally while maintaining future flexibility.
· Water for Injection (WFI): Purchasing WFI rather than installing on-site generation avoids upfront capital. If you defer the full install, consider installing distribution drops in every cleanroom during the base project construction to minimize future disruption. But be honest about what remains unresolved: an unfinalized automation strategy and incomplete validation documentation may require rework when the system is eventually commissioned.
· Emergency Power: Placing AHU fans on emergency generators with UPS controls is standard, but excluding HVAC chillers from emergency power is a big mistake. One does not work without the other (for very long). Use intelligent breakers to add and shed loads as needed, and carefully consider what should be on emergency power from the outset.
· Amenity Spaces: Even employee cafeterias benefit from forward-thinking infrastructure. Build plumbing, electrical, and ventilation to support future expansion; the incremental cost during construction is minimal compared to a retrofit.
6 Operational Lessons from ATMP Facility Experience
Day-to-day operations often reveal issues that are not obvious during design. These lessons reflect practical realities that can significantly impact reliability, maintenance, and compliance.
1. Maintenance access is very important. While LED fixtures can last 20 years, their drivers may not. Be sure not to route conduit over access panels for ceiling light fixtures. Doing so magnifies the complexity of simple maintenance tasks. Ensure maintenance access is considered for every installed component, not just the ones that are obviously serviceable.
2. AHU air intakes may have screens that can clog rapidly during pollen seasons and snowstorms. Plan for this with relief dampers, differential pressure alarms, or frequent cleaning schedules. Learning this operationally means risking cleanroom pressure excursions.
3. Concealed sprinkler heads in cleanrooms may use gasket materials that are incompatible with cleaning chemicals. Choose an appropriate device (check the fine print) or plan for replacement every 6–12 months.
4. Equipment movement between suites must be planned from the start in modular cleanroom configurations. Think through compliant relocation pathways, sterilizer placement, and the entry of sterile components into production areas.
5. Start-up checks deserve the same rigor as process validation. Generator sensitivity settings, transformer tap settings, switchgear testing, and duct leak testing should all be defined during design, not improvised during commissioning.
6. All underground piping should be visually inspected before pouring the floor slabs. Backfilling mistakes can happen, and repair costs (dollars and schedule) will be impactful.
Build, Protect, Start Up Your ATMP Facility
As elements are installed, ensure they are protected from the remaining work. This should be standard operation for bioprocess facility projects. Building an ATMP facility is a years-long commitment with consequences that can extend for decades. Every decision, from HVAC strategy to utility planning to what gets deferred, shapes operational performance, regulatory outcomes, and ultimately patient access.
The most successful projects share a common trait: they view design, construction, and start-up as an ongoing quality process rather than a series of handoffs. Addressing these details early is not just good project management; it is crucial to delivering therapies to patients who cannot afford delays.
Talk to our experts about best practices for ATMP facility design, construction, and operations.
Building a facility for advanced therapy medicinal products (ATMPs) is one of the most complex undertakings in pharmaceutical manufacturing. These facilities produce gene therapies, cell therapies, and other biologics that treat rare and ultra-rare diseases, often for patients with no alternative options.
The stakes are high. Design errors not only increase costs but can also delay life-saving treatments by years. Success requires more than just technical skill; it demands disciplined decision-making throughout design, construction, and operations. This guidance is grounded in Andelyn’s direct experience designing and building the Andelyn Commercial Center, a multi-product ATMP facility in Columbus, Ohio.
4 Competencies Required for a Successful ATMP Facility Project
The organizational structure of the project team is often the single greatest predictor of success or failure. High-performing ATMP facility projects are built around four core competencies, each with a distinct role in decision-making and execution:
- A seasoned facility leader (Owner) who can contribute valuable operational insights starting in the design phase of the project, all the way through to startup and turnover.
- A/E and Construction Management teams with experience in similar designs and builds.
- Project Executive leadership (Owner) with a pharma background to align the facility with long-term business and regulatory needs.
- Process experts (Owner side) who understand the manufacturing workflows that the ATMP facility must support.
Turning the Right Team into the Right Outcomes
Having the right team is essential, but not enough. How that team functions during design and construction ultimately influences the project's success. Three key practices consistently distinguish successful projects from troubled ones.
- Onboard an experienced facility leader early in the design phase, not after critical decisions have been locked in.
- Establish a formal change-order process from day one. Verbal agreements create ambiguity and risk.
- Vet your A/E and construction management teams for pharma-specific experience. Companies may have appropriate experience, but if the project team is lacking, the Owner must step up to fill the void.
Even with strong leadership and clear processes, execution risks often emerge at the interfaces between scopes. Specialty contractors may perform well within their domains, but gaps frequently appear where responsibilities intersect. The transition from wall to floor, from Vendor A to Vendor B, demands active CM oversight and is precisely where problems can hide.
HVAC: The Single Biggest Design Decision for ATMP Facilities
For a multi-product ATMP facility, HVAC design is the most consequential technical choice. The HVAC system is the foundation upon which your manufacturing house is built. The decisions made here directly impact contamination control, operational flexibility, and long-term cost structure. Some considerations:
· Single pass vs. recirculated air. Single-pass air handlers that supply 100% fresh air are a major advantage for cross-contamination control. The trade-off is higher utility and capital costs, but for any multi-product operation, the investment pays for itself in regulatory confidence and client trust.
· Dedicated vs. shared air handlers. Shared units are acceptable if the air is single-pass. Dedicated handlers offer maximum flexibility for rolling maintenance shutdowns without impacting neighboring suites, at the cost of higher capital and maintenance spend.
· Pressurization schemes. Both cascade and sink strategies have valid applications within a single facility. Match the approach to the contamination control strategy required for each area.
Commissioning vs. Qualification: Decide Before You Buy
Clarity around which systems will be commissioned versus formally qualified before procurement and fabrication begins is necessary. Retrospective qualification can be difficult and expensive, and it introduces risk to the project timeline. Define the boundaries clearly, document the rationale, and ensure alignment between the engineering and quality teams before issuing the first purchase order.
N+1 Redundancy: Where It Adds Value and Where It Doesn’t
Not all systems require redundancy, and overapplying N+1 design can quickly inflate capital costs without meaningful operational benefit. A targeted, risk-based approach delivers better outcomes.
· Where redundancy may not be justified: Compressed gas distribution systems andhumidification steam boilers often do not warrant backup units; evaluate theactual operational impact of routine maintenance work before committing capitalto a backup.
· Where redundancy proves its worth: Redundant supply and return fans in every AHU consistently deliver value. A fan failure in a GMP environment cascades through the entire production schedule, and the modest cost of backup fans is easily justified.
· Don’t overlook sequencing. The choice between lead/lag operation and both fans running at 50% affects energy consumption, wear patterns, and failover behavior. Do not let your controls contractor’s default assumption make this decision.
Utility Planning: Start Lean, Plan for Expansion
Utility infrastructure should reflect current needs without limiting future growth. Designing with expansion in mind avoids costly retrofits and operational disruption later.
· Gas supply. Start with cylinders and dewars rather than bulk storage tanks, but reserve the footprint for future tank installation.
· Electrical supply. Size for full design operations and negotiate upfront with the local utility for a clear expansion pathway.
· Process chilled water. ATMP process loads are generally much smaller than HVAC loads. Consider a separate temperature-controlled loop fed from HVAC chillers rather than dedicated process chillers that sit underutilized. Redirect the savings toward a backup HVAC chiller.
Deferred Decisions Don’t Disappear. They Compound.
Deferring scope can help manage capital, but unresolved decisions often resurface later, with increased complexity and cost. The goal is to defer intentionally while maintaining future flexibility.
· Water for Injection (WFI): Purchasing WFI rather than installing on-site generation avoids upfront capital. If you defer the full install, consider installing distribution drops in every cleanroom during the base project construction to minimize future disruption. But be honest about what remains unresolved: an unfinalized automation strategy and incomplete validation documentation may require rework when the system is eventually commissioned.
· Emergency Power: Placing AHU fans on emergency generators with UPS controls is standard, but excluding HVAC chillers from emergency power is a big mistake. One does not work without the other (for very long). Use intelligent breakers to add and shed loads as needed, and carefully consider what should be on emergency power from the outset.
· Amenity Spaces: Even employee cafeterias benefit from forward-thinking infrastructure. Build plumbing, electrical, and ventilation to support future expansion; the incremental cost during construction is minimal compared to a retrofit.
6 Operational Lessons from ATMP Facility Experience
Day-to-day operations often reveal issues that are not obvious during design. These lessons reflect practical realities that can significantly impact reliability, maintenance, and compliance.
1. Maintenance access is very important. While LED fixtures can last 20 years, their drivers may not. Be sure not to route conduit over access panels for ceiling light fixtures. Doing so magnifies the complexity of simple maintenance tasks. Ensure maintenance access is considered for every installed component, not just the ones that are obviously serviceable.
2. AHU air intakes may have screens that can clog rapidly during pollen seasons and snowstorms. Plan for this with relief dampers, differential pressure alarms, or frequent cleaning schedules. Learning this operationally means risking cleanroom pressure excursions.
3. Concealed sprinkler heads in cleanrooms may use gasket materials that are incompatible with cleaning chemicals. Choose an appropriate device (check the fine print) or plan for replacement every 6–12 months.
4. Equipment movement between suites must be planned from the start in modular cleanroom configurations. Think through compliant relocation pathways, sterilizer placement, and the entry of sterile components into production areas.
5. Start-up checks deserve the same rigor as process validation. Generator sensitivity settings, transformer tap settings, switchgear testing, and duct leak testing should all be defined during design, not improvised during commissioning.
6. All underground piping should be visually inspected before pouring the floor slabs. Backfilling mistakes can happen, and repair costs (dollars and schedule) will be impactful.
Build, Protect, Start Up Your ATMP Facility
As elements are installed, ensure they are protected from the remaining work. This should be standard operation for bioprocess facility projects. Building an ATMP facility is a years-long commitment with consequences that can extend for decades. Every decision, from HVAC strategy to utility planning to what gets deferred, shapes operational performance, regulatory outcomes, and ultimately patient access.
The most successful projects share a common trait: they view design, construction, and start-up as an ongoing quality process rather than a series of handoffs. Addressing these details early is not just good project management; it is crucial to delivering therapies to patients who cannot afford delays.
Talk to our experts about best practices for ATMP facility design, construction, and operations.