Biotech and Pharmaceutical

WSP understands the challenges that the pharmaceutical industry is facing with R&D pipeline issues, the reduction in the cost of goods after manufacturing, regulatory reforms, and environmental concerns. 


Amid scientific and technological advances, changing demographics and population growth, and an ever-increasing global demand for medicines, pharmaceutical and biotech clients must respond with agility, adopting shifting business models to achieve growth, increase efficiency, capitalise on opportunities and be prepared to address future industry considerations. These include environmental concerns, changing customer expectations and needs, cost of goods, speed-to-market, R&D pipeline issues, scientific productivity, and compliance and risk management. 

For many years, WSP has been helping our clients to remain competitive with our specialist expertise and proven experience in the design and delivery of research and development facilities and manufacturing plants, as well as in process engineering, warehouse planning and logistics, and in the design of corporate headquarters. 

Focusing on thoroughly understanding our clients' needs, constraints and goals, in both developed and emerging markets, our project teams in our business regions across the globe provide in-depth, specialist knowledge of the local industry issues, business culture and regulatory requirements.  When required, our local teams can call on the extensive global expertise of our consultants and engineers in our process engineering centre of excellence and our pharmaceutical and biotech hubs around the world.

Strategic and Front-End Consulting Solutions to Meet Operational and Manufacturing Needs

We offer technical expertise and timely and sustainable solutions to help our clients address concerns with compliance, operating costs and capital investments, asset location and manufacturing efficiency, and facility and equipment readiness to meet future business and production requirements. We can provide strategic advice on upgrading and redeveloping existing facilities to acquiring sites in new geographical regions, conducting full life cycle cost analysis as well as insightful analysis on rapidly-changing technologies that are driving drug development and lean manufacturing operations.

Our robust business process enables us to assist clients to shortlist, analyze and appraise options, assessing both non-financial benefits and risks.

  • Pre-feasibility and Feasibility studies
  • Funding and Investment appraisal 
  • Assets integrity management
  • Capital Program management
  • Business and strategic planning
  • Concept design / master planning 
  • FEED studies
  • Process engineering
  • Fluid flow analysis
  • Process flowsheets
  • Basic and detailed engineering
  • Engineering, procurement, and construction management (EPCM)
  • Project and construction management
  • Commissioning 
  • Validation
  • Building Information Modelling (BIM) 
 

Review and Selection of Equipment and Technology for Bulk and Secondary Manufacturing Plants, R&D, Warehouse and Infrastructure Support Facilities

With scientific change and the evolution of new diseases and medical treatments, pharmaceutical and biotechnology clients frequently require facilities with well-designed, contained material follow, volume/capacity and production flexibility, transferrable analytical technologies, good manufacturing practices, all the while meeting stringent health and safety regulations. 

We have extensive expertise in the design, engineering and construction management of bio/pharmaceutical manufacturing plants, research and development centres, clean rooms, specialized laboratories and controlled environments (including the highest containment levels and biological safety levels), as well as the design and specification of equipment, integration of new process equipment and modifications to existing systems, without disrupting ongoing production activities.

 
  • Formulation and dosage facilities (solid, liquid, vial and inhalers)
  • Sterile suites and packaging
  • Research and development facilities
  • Laboratories
  • High-containment laboratories and facilities
  • Clean rooms
  • Aseptic suites 
  • Flexible facilities
  • Production and packaging facilities
  • Medical devices
  • Containment and process safety
  • Laboratory and clean room design
  • Specialty testing
  • Quality assurance
  • Scanning facilities
  • Architectural and engineering design
  • Process intensification
  • Process modelling
  • Automation
  • Software development
  • Refrigeration
  • cGMP

Commissioning, Qualification and Validation Services to Ensure Compliance 

We work with clients at start-up to ensure facilities are compliant with GMP and regulatory agency requirements, and through our qualification and validation services use advanced risk-based approaches and tools to authenticate and ensure that everything - processes, utilities, manufacturing equipment, ventilation systems and temperatures, humidity, airflows, water quality and supply chain, among others - performs smoothly and meets client specifications. 

  • Integrated commissioning and qualification (ICQ) 
  • Validation master plan (VMP)
  • Validation protocol format
  • Design qualification (DQ)
  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • Performance qualification (PQ) 
  •  Current good manufacturing practice (cGMP) review

  • Continued process verification (CPV)

  • Pre-Operational Verifications 

  • Commissioning and Startup

  • Training

  • Technical audits and due diligence

  • Good automated manufacturing practice (GAMP)


Health, Safety Environment and Quality Management

Our team also provides detailed support for environmental, health, safety, sustainability, and energy requirements management. As no two clients are alike, neither are their projects.  We offer an extensive suite of services from strategic support to meet sustainability challenges, planning support for new facility and manufacturing developments, as well as assistance in meeting the full range of safety and environmental requirements, including process safety, design safety review, major accident hazard management, and emissions control and permitting.

WSP also has a group of top tier international experts who support clients in the pharmaceutical and biotech supply chain with product stewardship and product safety requirements, including REACH chemicals policy and hazard classifications.

  • Safety design reviews
  • Hazard studies including HAZOP
  • Hazard analysis (HAZAN)
  • SWIFT and What-If studies
  • CHAZOPs
  • SIL (safety integrity level) analysis
  • Hazardous area classification and DSEAR studies