Life Sciences

Lorien has a long association with work in the Life Sciences industry for over 20 years, with experience in a wide range of applications.

Our engineers and project managers have direct application experience of:

  • Manufacture of APIs
  • Various final dosage forms: tablets, capsules, liquid dose, aerosol dose
  • In-vitro diagnostics
  • Discovery laboratories
  • Regenerative medicines, including advanced cell therapy applications
  • Tissue engineering
  • Biomedia production
  • Industrial biotechnology
  • Advanced manufacturing

Lorien supports clients in the establishment of new facilities and the adaptation of existing facilties to meet new needs. In particular we engineer solutions for;

  • Design of complete manufacturing and research facilities
  • Discovery and production laboratories
  • GMP manufacturing suites, including steriles
  • Plant utilities, including HVAC, purified water, SIP
  • API processing
  • Fill/Pack plant
  • Dispensary plant
  • Logistics flow design and storage facility design

We are actively engaged in Regenerative Medicine developments, taking proof of concept products through to regulatory approval and launch. Currently we are working in collaboration on a post operative skin cancer tissue repair scaffold, a Class III Medical Device, helping to bring this product to clinical investigation phase in 2015.

Our service delivery includes;

  • Technical design studies
  • Product feasibility studies
  • Design to tender and tender assessment
  • Detailed design
  • Scheme implementation, including construction planning, procurement and execution management
  • Construction safety management
  • GMP risk management (system impact assessment, project validation plans, FMEA (ISO60812)
  • Clinical risk management (for example ISO14971 Risk Control, and ISO13485 QMS for medical devices)
  • Product development programme management, including CE Marking
  • Machine and area safety (see our Compliance pages).