New Production Facility to Support the Manufacturing Monoclonal Antibodies (mAbs)

New Production Facility to Support the Manufacturing Monoclonal Antibodies (mAbs)

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Our customer a leading pharmaceutical manufacturer needed to increase the production capacity of monoclonal antibodies as bio-pharmaceutical drug substance using mammalian cell cultures. As a result, a new greenfield facility plant of 25’000 m2 was planned in Singapore.
 

Key Results

  • Delivery of a over 25’000 m2 greenfield facility
  • Area lead responsibility – for upstream, buffer & media preparation, CIP, laboratories, clean media
  • Integrated superskid approach resulted in accelerated schedule
  • Delivery of both fixed and disposable technologies 
  • Intelligent coordination of 3D models
     

Key Project Features

  • State of the art concept plan
  • Modular process and automation design
  • Flexible QC laboratory and small scale disposable design
  • Innovative materials warehousing solution
  • Superskid vendor coordination through design, construction and installation
  • International project coordination
     

Our Delivery

  • Collaborative concept design with the client team with particular focus on HSE protection in the handling of highly active API’s
  • Feasibility, basic and detailed process design, laboratory and clean utilities design.
  • Lead teams of contractors through the design, commissioning and qualification process
  • Vendor presence during superskid construction process
  • Fully modular concept allowing installation of two further bioreactor trains and additional DSP line
  • Coordinated vendor and main plant 3D models
     

Value to Our Customer

  • Delivery of a greenfield, state of the art production facility
  • Innovative skid and superskid approach
  • Modular technology
  • Innovative, lean laboratory process design allowed integration of the laboratory into the main production building
     

Key Applied Capabilities

  • Consulting

    We offer expert, individually tailored consultant services to our clients in the feasibility stages of new facilities or processes, tech transfers and scale-ups.

  • Facility Design

    We specialise in full facility design, integrating complex functional processes and laboratories throughout their entire life cycle.

  • Process Engineering

    We understand our clients’ operational and quality process needs, applying industry leading ideas from some of the best minds in our field.

  • Technology Transfer & Scale-up

    We design and incorporate innovative processes that can be scaled up or easily transferred to other locations.

  • Project Management & Controlling

    With our hands-on approach to project delivery strategies, our experienced project managers and their teams define and manage schedules, budgets and deliverables throughout the project lifecycle.

  • Construction Management & HSE

    Our robust CM tools and skilled teams enable us to develop specific plans that deliver projects safely and to scope, time and budget.

  • C&Q / QA / QP / MDR

    We support our clients in efficient and integrated commissioning and qualification, quality assurance, qualified person and medical device regulation activities.

  • Virtual Reality & 3D Solutions

    Our clients demand the latest and most effective digital tools in the delivery of our designs.

  • Laboratories

    Intelligent environments and smart processes. Innovative integrated laboratory solutions delivered by our expert engineers, scientists and architects.

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