Projects

Selected recent Modular and Turnkey delivery Projects

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

Biotechpharma UAB

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

Octapharma, Sweden

Plasma fractionation, Capacity increase project

Scope: Detailed design, project management and construction management.

Major drivers: Short and predictable installation during production stop.

Objective: Design, plan and installation of new equipment and modification of existing systems during planned production stop.

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

OSD Facility

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