Biotechnology

Biotechnology is one of our biggest specialisms at BPE. We have undertaken a wide range of highly successful projects within the sector, for organisations of all shapes and sizes.

Drawing on our extensive experience, we can support projects that are at early stage or those that are currently in process. We help businesses assess and consider concept designs, scale-up and modelling, and help to advance plans through to detailed design, construction and verification. Among the areas we can support biotechnology firms in are:

  • Production of biological active pharmaceutical ingredients (APIs)
  • Upstream systems including microbial or mammalian expression systems
  • Primary recovery and downstream processing
  • Biological finished products including sterile fill finish (aseptic filling) and freeze drying
  • Vaccines production, for human and animal use, with biocontainment requirements up to ACDP and SAPO4.
  • Blood products
  • Hard-piped systems and the application of single-use technologies

Read how our work helped a biotechnology manufacturer firm up its plans for a new production plant to produce an animal virus antigen.

 

Find out how we helped a biopharmaceuticals firm assess the feasibility of refurbish an existing, under-utilised pilot facility to accommodate a small scale GMP bio-manufacturing process.

For more details please call us on (0)1962 717070 or click here

Design Capabilities

  • Process Engineering Design from concept to construction Process Modelling and Optimisation using Superpro
  • Equipment design, specification and integration
  • Expert hygienic piping design and modelling
  • Control system design & implementation to the latest Good Automated
  • Manufacturing Practice (GAMP) standards as defined by the International Society for Pharmaceutical Engineering (ISPE)
  • Clean Room and facility integration
  • Cleaning/Sterilisation Systems (CIP/SIP) Design and Specification

 

Integrated Services

  • Specialist Project Management
  • Compliant Construction Management including Construction Design and Management (CDM) services
  • Integrated commissioning and qualification
  • Lifecycle management of high value equipment
  • Process Safety and Biosafety consultancy

 

Facility Support

  • Overall facility integration including process architecture
  • Facility flow, classification, containment and HVAC  (Heating, ventilation and air conditioning) concepts.
  • Expert design, construction and qualification of clean services including high purity water, steam, air and gas systems
  • Chemical storage, dispensing and handling systems
  • Site utilities
  • Environmental protections systems including gaseous, liquid and solid waste handling and treatment
  • Biowaste handling and treatment