Biotech and Pharmaceutical

WSP understands the challenges the pharmaceutical and biotech industry faces with R&D pipeline issues, the reduction in the cost of goods after manufacturing, customer demands, evolving regulatory reforms, environmental concerns and a myriad of issues to remain competitive.




Beyond researching, developing and manufacturing generic and brand-name prescription drugs, the pharmaceutical and biotechnology industry faces complex challenges and unique risks in delivering and marketing the best medicines and products needed to maintain healthier lives.

Amid scientific and technological advances, changing demographics and population growth, and an ever-increasing global demand for medicines, pharmaceutical and biotech clients are readying themselves to respond with agility and acquiescing to shifting business models to help ascertain areas of growth, remove redundancies, capitalize on opportunities, and address future industry considerations. These encompass a slew of matters that include environmental concerns, efficiency demands, customer expectations and needs, cost of goods, speed-to-market, R&D pipeline issues, emerging markets, scientific productivity, and compliance and risk management.

WSP has in-depth industry knowledge, specialist expertise and demonstrated technical and product delivery capabilities in research and development facilities, pharma and biotech manufacturing processes and plants, warehouse planning and logistics, and corporate headquarter build designs.

Focusing on thoroughly understanding the needs, constraints and goals of clients in developed and emerging markets, we can pull together project teams locally, and when required reach out to our consultants and engineers in our process engineering’s centre of excellence and our pharmaceutical and biotech hubs around the world. They can deliver tailored and out-of-the-box technical, environmental and management solutions, advise on international best practices, emerging trends and regulatory developments, provide a full EPCMV offering as well as recommend effective strategies to help mitigate compliance risks, increase margins, maximize assets and gain the needed competitive edge.

Automation project at Influenza Vaccine Manufacturing Facility, UK. Winner of the 2013 ISPE Facility of the Year Award for Equipment Innovation. Photo courtesy of Jeannette Hägglund.

 

High-Quality Services at All Project Phases: Pre-Investment to Operational Handover

From research and development to commercial realization and full-scale manufacture, we provide integrated multidisciplinary engineering that encompasses consultancy, design, engineering, project and construction management, and commissioning and validation services. Our rigorous yet flexible approach has earned the trust of diversified and non-diversified multinationals such as GlaxoSmithKline and AstraZeneca, as well as renowned research facilities and institutes.

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
  • cGMP
  • Specialty testing
  • Quality assurance
  • Scanning facilities
  • Architectural and engineering design
  • Process intensification
  • Process modelling
  • Automation
  • Software development
  • Refrigeration
     

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) 
  • Good automated manufacturing practice (GAMP)
  • Current good manufacturing practice (cGMP) review
  • Continued process verification (CPV)
  • Pre-Operational Verifications 
  • Commissioning and Startup
  • Training
  • Technical audits and due diligence

National Institutes of Health, National Institute of Allergy and Infectious Diseases, Integrated Research Facility, Rocky Mountain Labs, Hamilton, Montana, USA. Photo Courtesy of Architecture 49

 

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