ProjectsSelected recent Modular and Turnkey delivery Projects
Modular biomanufacturing and aseptic filling facility, Latin America
Scope: Delivery of an outdoor modular facility of 6.300 sq. m. including all process equipment. Facility based on KeyPlants design platform Modular Bio Solutions (MBSTM).
Major drivers: Predictability, Speed, Quality
Objective: Turnkey delivery to greenfield site.
Multi-product biomanufacturing facility, Sweden
Scope: Process simulation, design and project delivery including C&Q. Buffer hold, CIP, clean utility, change of process streams and upgrade of process automation system.
Major drivers: Predictability, Quality, Schedule, Experience
Objective: Near doubled the site production capacity.
Saudi Bio, Saudi Arabia
Modular aseptic formulation and filling facility
Scope: Delivery of an indoor modular facility based on KeyPlants design platform Modular Aseptic Solutions (MASTM). Filling of vials, cartridges and pre-filled syringes, including lyophilization.
Major drivers: Predictability, Speed, Quality, Flexibility
Objective: Turnkey delivery of a qualified facility in 16 months.
Ferring, Germany and Indonesia
Modular movable filling facility
Scope: Turnkey delivery of an indoor modular facility to Germany for commissioning and training of personnel. Further delivery to final site in Indonesia.
Major drivers: Rapid deployment, overcome Tech Transfer challenges and accelerated approval
Objective: Turnkey delivery of a movable facility.
Aseptic filling facility, BSL-3
Scope: Pilot scale aseptic filling facility in an existing building. Vial filling line in isolator.
Major drivers: GMP compliance
Objective: Facility for new product launches.
Big Pharma, Sweden
Compounding and dispensing suite
Scope: Installation of new clear room area including integration with existing systems (HVAC, Electrical, Sprinkler, Automation etc.).
Major drivers: GMP compliance, minimal interference
Objective: Design and execute with high predictability to a fixed budget and timeline.
Merck & Co, USA, Netherlands
Modular Ammonia Plant
Scope: Design, off-site construction, on-site installation and integration.
Major drivers: Safety, speed and predictability
Objective: Turnkey delivery of the ammonia plant on a congested site within 6 months.
Teruisi Pharmaceutical Inc., China
Greenfield Mab Manufacturing Facility
Scope: Conceptual design for greenfield facility together with Hyde Engineering. Fabrication and delivery of purification and bulk filling modular skids.
Major drivers: GMP compliance, predictability
Objective: Turnkey delivery of GMP-compliant skids including site integration to schedule and budget.
Merck & Co, USA
Weighing and Dispensing Facility in Switzerland
Scope: Basic design, fabrication, integration of process equipment, assembly.
Major drivers: Speed
Objective: Turnkey delivery of the facility through off-site construction within 6 months
Stragen Pharma, Switzerland
High Containment OSD Facility, Greenfield
Scope: Design, off-site fabrication, on-site installation and qualification of an OSD manufacturing facility.
Major drivers: GMP assurance, predictability, speed
Objective: Turnkey delivery of a qualified OSD facility within 15 months
Teva Sicor Biotech UAB, Lithuania
Skid Delivery Project, Expansion project
Scope: Design, fabrication and qualification of modular process skids
Major drivers: Quality, schedule, cost
Objective: Turnkey delivery and qualification of modular protein solution skids within 6 months
Skid/Equipment Delivery Project
Scope: Turnkey delivery and qualification of buffer and protein solution skids.
Major drivers: Quality, schedule, cost
Objective: Design, manufacturing, start-up, IQ/OQ and handover on site within 6 months
Teva Sicor Biotech UAB, Lithuania
Skid Delivery Project, re-order
Scope: Turnkey delivery and qualification of modular process skids
Major drivers: Cost, schedule, quality
Objective: Design, fabrication, start-up and IQ/OQ and handover on site within 10 months
Schering Plough Corporation, Summit, NJ, USA
OSD/LVP Clinical Supply Facility
Scope: Hybrid modular project at former Pharmadule AB for Schering Plough Corporation. OSD, aseptic and non-aseptic LVP filling, an integrated global clinical process facility of 4 700 sq. m., including all work from CD, fabrication, process equipment, delivery to operational qualification.
Project Drivers: Site integration, benchmark and best practice design, flexibility and change-over time, handling of multiple batches and active ingredients – no cross contamination
Genentech, South San Francisco, CA, USA
Aseptic Filling and Lyo Facility
Scope: Project at Pharmadule AB for Genentech. Delivery of aseptic filling/lyophilization standalone modular facility of 3 000 sq. m., including all process equipment.
Project Drivers: Schedule, predictability, risk mitigation through pre-qualification of equipment in workshop
Capacity increase project with skids and off-site construction
Scope: Expansion of plasma fractionation facility. Installation of tanks and clean utility systems including piping.
Major drivers: Short and predictable installation during production stop
Objective: Increase capacity with limited time for installation.
GSK Bio, Hamilton, MT, USA
Biotech API Facility
Scope: Project at former Pharmadule AB for GSK Bio. Biotech API facility of approx. 2 800 sq. m. for production of MPL vaccine adjuvant. The work included all activities from basic design, fabrication, equipment procurement, and site assembly to operational qualification.
Project Drivers: Schedule, remote location – local labor constraints
Merck & CO, Durham, NC, USA
Aseptic Filling and Lyophilization Facility
Scope: Project at Pharmadule AB for Merck & CO. Aseptic filling facility of 6 000 sq. m. constructed in 2 levels on a utility basement.
Project Drivers: Schedule, cost, predictability
Eli Lilly, Kinsale, Ireland
Sterile API Manufacturing Facility
Scope: Project at former Pharmadule AB. Turnkey delivery of a sterile API manufacturing facility of 5 000 sq. m. The work included all activities from basic engineering to completed commissioning and handover.
Project Drivers: Schedule, predictability, local labor constraints
Merck & CO, Singapore
Scope: Project at former Pharmadule AB for Merck & CO. Greenfield project for a high share oral solid dosage facility of 3 000 sq. m. The modular facility was assembled and fully commissioned in workshop prior to shipping to Singapore for rapid handover for operation.
Project Drivers: Schedule, predictability, risk mitigation through equipment testing (pre-qualification) in workshop, standardization
RITM, Manila, Philippines
Biopharmaceutical API and Aseptic Filling Facility
Scope: Project at Pharmadule AB for Biological Production Services (Department of Health). BCG vaccine API and Aseptic Filling Facility as a turnkey delivery.
Project Drivers: GMP compliance, schedule, predictability
Cook Imaging – (Acquired by Baxter), Bloomington, IN, USA
Aseptic Formulation, Filling & Lyo Facilities
Scope: Projects at Pharmadule AB for Cook Imaging (Baxter). Turnkey projects including an extension delivery of an aseptic filling and automated lyo facility of approx. 3 000 sq. m. from conceptual development to completion of OQ.
Project Drivers: Schedule, cost, and pre-qualification of equipment in workshop