Biotechnology & Regenerative Medicine

Petri Dishes Biotech fermentation process Regener8 member

Businesses in the biotechnology and translational regenerative medicine sectors have particular needs: taking lab-scale processes and translating these in to commercial scale production; critically reviewing the current and anticipated requirements of regulatory bodies and translating these in to engineered solutions. 

The unique issue with Biotech and Regen Medicine is that as the science is often brand new, so the solutions to these needs must also be new and innovative, but still based upon sound experience and tried and tested project development methods.  This is where Lorien Engineering Solutions comes in.

We offer design and project management services for manufacturing, research and pilot facilities.  With access to industry expertise in facility design, containment technology, regulatory requirements and validation methods, our approach is one of 'no surprises' when it comes to the design of new processes and facilities.

Achieving a 'no surprises' project requires careful planning, right at the start, prior to project appropriation of funds. Many biotech projects attract public and private equity funding, and the terms of such funding (in amount and time frames) are quite challenging. Up-front knowledge of facility requirements, from space needed, through to logisitics, manning, and the control of people and materials, is of the highest importance.

Involvement of Lorien's expertise at or prior to the start of clinical trials will help to remove many of the hurdles to scale-up and commercialization, and to improve investor and funding body relations.

In addition, Lorien can assist companies at the project feasibility stage, and leading up to this with support during grant funding applications.

Our competent staff cover all disciplines - architectural, civil and structural engineers as well as specialist engineering teams for process, chemical, automation, packaging, utilities and mechanical and electrical building services. We have good familiarity of laboratories, cleanrooms, production facilities and support areas.

We take capital investment projects from concept stage through detail design to on-site management and handover.

Lorien is proud to be associated with Regener8: the N8 Centre for Translational Regenerative Medicine. For further information visit, www.regener8.ac.uk

 


Summary

Team of experienced and qualified designers within the biotech sector. 

Well-proven and audited quality management system. 

Working for both blue-chip and new science clients. 

Good advice, when it's needed. 

Fully integrated with engineering design and project management.

Profile

Taking facility and process design from URS ( and pre-URS) through to completed facilities that are compliant and practical to use. 

Proficient in GMP/GLP, as well as supporting processes such as HAZOP and FMEA reviews,
DSEAR and PUWER studies. 

Facility design, utilities, processing, packing, automation - all in one place.

Experience

Allogenic cell generation production  labs

Fermentation Labs and support areas 

Scintillation Labs 

Process flash chilling  

Production automation 

Cell culture facilities 

High purity water systems