New 50L GMP Plasmid Stream, Keele

The Opportunity

Charles River Laboratories (CRL) Stephenson Building is situated within the Keele University Campus. This facility supports the development and manufacturing of cell and gene therapy in the form of plasmid DNA for clinical and commercial supply.

The facility has over 145 staff and is made up of c. 1400m² of manufacturing and 300m² of warehouse space. The manufacturing space has 10+ ISO 7 Grade C production suites in two manufacturing areas. All areas have HEPA-filtered HVAC and operations are product specific.

CRL had the urgent need to upgrade the existing (Phase 1) RNAse-free 50L process within the Stephenson Building by repurposing existing cleanrooms in the facility to create one additional (Phase 2) upstream train and one additional (Phase 2) downstream train. The project plan was to co-locate the Phase 1 and Phase 2 upstream areas on one side of the building, so that all the live processes were together.

In order to undertake the required works, the shutdown period was set at two weeks. This was one of the main challenges of the project. The narrow shutdown window was required to accommodate CRL’s manufacturing commitments.

The Solution

At the outset, it was found that record information was limited and, additionally, a complete survey was not feasible whilst the sterile area was in production. In order to complete the preliminary design, agreed and considered assumptions were used.

During the site survey, value engineering opportunities were identified to reduce the scope of the builder’s work for the planned shutdown. As an example, to relocate equipment in lieu of the installation of a new compressed air supply, saving a significant amount of builders’ work, time and associated cost.

Project scope included remodelling four small rooms into two larger rooms; the combined room was designed to be Grade C, and all other rooms remained at their current Grade levels.

Floors, walls and ceilings were finished with sheet vinyl to match the existing GMP areas.

As part of the project, new services were introduced in various key locations to serve new and relocated equipment use as part of the process stream.

Through strategic project planning broken down as daily and hourly elements, the project was completed on time and within the tight shutdown duration to meet the manufacturing commitments and quality aspirations.

“Austin were very client focused and determined in driving the project to success. They delivered the project on time and on budget. I felt that Austin were a good choice for our project.”
Nicholas Leonard – Associate Director Global Category Procurement, Charles River Laboratories

“Austin’s design was good considering limited information provided and lack of access to hidden services. Their Construction Project Management was excellent, very helpful and accommodating.”
Keith Miller – Project Manager, CBRE

Pharm Ops Building, Formulation and Analytical Laboratories, Hoddesdon

The Opportunity

Pharmaron required Austin to undertake various condition surveys and prepare separate concept designs to house Analytical Chemistry and GMP formulation business functions on the site at Hoddesdon.

This led into the preliminary design stage, where Austin consolidated various concept design options developed into a single project for a leaner dependency between business functions and to leverage economies of scale.

Through further refinement of user requirements, the project scope was defined. Upon acceptance, Austin prepared the detailed design solution, project programme and cost estimate for Pharmaron’s approval.
The project included:

• Review of laboratory functions and redevelopment of existing office space into a new forty-six station analytical chemistry laboratory.
• Creation of new floor plate within existing voids to contain subsidiary spaces, including balance rooms, glass wash areas, yellow light facilities and technical support areas for reagents, solvents and additional daily consumables.
• Laboratory protocol assistance with technology support for data collection and information distribution.
• Redesign of existing offices to suit current working practices, including teamwork areas for international meetings and collaboration.
• Review the existing process facility and develop them to meet c.GMP standards.
• New laminar down flow booth for small batch and bulk dispensary.
• 2 No. purified water systems – an independent system to serve AC3 labs, and another validated generation plant connected to an existing loop to serve the c.GMP formulation areas.
• Update of existing receipts and dispatch area to support the new building use.
• Major overhaul of existing process effluent drainage skids, controls software and philosophy. This extended to repurposing of 40 No. existing control panels and over 700 No. new field devices.
• Provision of centralised Compressed Air and Nitrogen generation plant.
• Austin provided detailed design, procurement, construction, commissioning and supported Pharmaron with validation activities through to operational status.

The Solution

Pharmaron needed to bring a modern dormant asset back into economical use. The Pharm Ops building was not used for several years with the M&E plant and components partially missing and/or not operational.

Pharmaron required Austin to:

• Undertake detailed and careful assessment working closely with Pharmaron to establish the scope, use and phasing strategy to bring the building back to operation.
• Work with the users in developing potential uses and developing hierarchies of new needs.
• Identify schemes that facilitated economies of scale and allowed for the overall project to be greater than the sum of its constituent parts.
• Ascertain long lead elements for early execution of construction and develop budgetary expenditure models for fast project implementation.
• Use as much of the available infrastructure as possible, this entailed considerable surveys and understanding of the existing BMS and Steam systems to allow this to be upgraded with other site wide requirements.

Once the scope and use of the building was agreed, Pharmaron required the facility to be delivered in a very limited period of time to meet business needs.

Fleming Building, Phase 2 Laboratory Suite Development, Hoddesdon

The Opportunity

In order to support pharmaceutical production activities on site, Pharmaron made a strategic decision to fit out the fallow area on the second floor of the Fleming building into laboratories for Process Chemistry.

Owing to Austin’s expertise in design and construction of highly technical facilities as well as previous development of Phase 1 concept study, Pharmaron approached Austin with an opportunity to provide a turnkey solution that would meet their time, quality and cost needs.

Austin suggested utilising The Austin Method^® for project delivery. This entails providing a Step 1b – Preliminary Design as it allows development of drawings, outline specifications, programme and ±10% cost estimate in a shorter period than the traditional method to allow Management Approval earlier for the whole project. This then follows by progressing the project immediately into Step 2 – Detailed Design stage, competitive procurement through to construction minimising the overall project timescales significantly.

The Solution

Austin undertook detailed site surveys and briefing workshops with the user groups and key stakeholders to develop the requirements for the Phase 2 Chemistry laboratory fit-out of 2^nd floor fallow area. The brief was to match Phase 1 in terms of finishes, however, improve on performance.

Lessons learnt from the previous phase were discussed, analysed and applied to this phase. This included:

• Engaging with the team very early to define laboratory equipment and services provisions.
• Coordination of MEP services using 3D modelling to facilitate design reviews and maintenance access.
• Designing the requirements to limit noise and vibration during construction due to adjacent operational areas.

Key challenges in developing the solution included:

• Providing sufficient air flows for 58 No. variable air volume fume cupboards.
• 26 m³/s Air Handling Unit.
• Provision for heat recovery on the supply and fume extract systems (26 m³/s).
• Integration of an additional 1MW boiler to provide heating.
• Design and install mechanical plant room for ventilation, including supply only of AHU and cooling coil.
• Extension of the existing compressed air and nitrogen system plus relocation of existing nitrogen pressure regulating set.
• Modifications to existing ductwork installed in Phase 1 to facilitate new works.
• Tie-ins for MEP and sprinklers to existing operational systems.
• Maintaining project progress during national COVID-19 restrictions.
• Including provision of supplementary ventilation to an existing plant room.

Laboratory Refurbishment, Bracknell

The Opportunity

Afton required the existing HVAC system feeding seven laboratories on the ground floor of their Bullbrook Building to be replaced so that they are compliant with BS EN 14175 and HSG 258, and at the same time to improve diversity and utilisation of the fume cupboards and LEV systems.

To provide Afton with a ±10% estimate and a delivery programme, Austin were requested to develop a preliminary design to ascertain the most appropriate way to replace the HVAC system with minimal disruption, keeping all the other working laboratories operational. The design required reconfiguration of fume cupboards and laboratory benching in each of the seven laboratories along with modifications to associated process water, gases and, where possible, reusing existing benching.

Space constraints necessitated the ductwork systems be designed around existing services within the ceiling voids and overcoming physical building constraints of the occupied areas.

Modelling of maximum and minimum operational laboratory air flows with seasonal demand matching were required to assess the maximum chilled water and low temperature hot water system demands utilising heat recovery to ensure an energy efficient design.

Value engineering analysis, constructability reviews and construction planning reviews were undertaken to achieve construction efficiency and continuity.

Upon conclusion of the preliminary design, Afton required Austin to undertake the next stage through to completion.

The Solution

Afton required the existing HVAC system feeding seven laboratories on the ground floor of their Bullbrook Building to be replaced so that they are compliant with BS EN 14175 and HSG 258, and at the same time to improve diversity and utilisation of the fume cupboards and LEV systems.

To provide Afton with a ±10% estimate and a delivery programme, Austin were requested to develop a preliminary design to ascertain the most appropriate way to replace the HVAC system with minimal disruption, keeping all the other working laboratories operational. The design required reconfiguration of fume cupboards and laboratory benching in each of the seven laboratories along with modifications to associated process water, gases and, where possible, reusing existing benching.

Space constraints necessitated the ductwork systems be designed around existing services within the ceiling voids and overcoming physical building constraints of the occupied areas.

Modelling of maximum and minimum operational laboratory air flows with seasonal demand matching were required to assess the maximum chilled water and low temperature hot water system demands utilising heat recovery to ensure an energy efficient design.

Value engineering analysis, constructability reviews and construction planning reviews were undertaken to achieve construction efficiency and continuity.

Upon conclusion of the preliminary design, Afton required Austin to undertake the next stage through to completion.

THC 2 Laboratory, Building 102 R&D Facility, Milton Park

The Opportunity

Global pharmaceutical group Ipsen’s ambition is to be a leader in specialty healthcare solutions for targeted debilitating diseases. This strategy called for the consolidation of their research in the heart of leading biotechnological and life sciences hubs.

Ipsen required additional THC2 (toxic handling criteria) laboratories to be provided within an area of fallow space in their R&D facility in Abingdon and engaged Austin, who had previously undertaken Phase 1 extension and fit-out of this facility to carry out these Phase 2 works.

In order to develop this opportunity and assess the feasibility of these proposals, Austin initially undertook a concept study to define Ipsen’s detailed requirements. Subsequently Austin developed the opportunity into a viable detailed design in order to deliver this important facility to support Ipsen’s global aspirations for this building.

The Solution

Austin collaborated with Ipsen to design and deliver a state-of-the-art flexible laboratory conforming to Ipsen’s toxic handling criteria THC2 standard for working with non-toxic biologics. The laboratory accommodated analytical equipment to support analysis of in-house samples and improve product and process understanding.
This entailed:

• an airlock lobby to link the laboratory and the existing second floor THC2 laboratory suite.
• a refuge lobby from the laboratory with an exit directly to the central staircase
• an equipment store room to support laboratory functions
• provision of a dedicated ventilation system allowing the THC2 laboratory to be constructed without interruption to the main building systems.
• a rigorous security philosophy to meet Ipsen’s and the Home Office anti-terrorism legislation.

Part of the success of this facility is directly attributed to:

• Austin’s previous experience, during the design and delivery of the Phase 1 works, which gave consideration to the future development of the fallow area on the 2^nd floor.
• close collaboration between Ipsen and Austin which facilitated early identification of challenges.
• designing in 3D using Revit (BIM) to provide certainty on delivery and maintenance requirements. This meant there were very few site changes and therefore more control and certainty on cost and time.

Challenges presented included:

• carrying out construction work on the second floor which already accommodates a fully operational laboratory facility with stringent containment protocols.
• minimising access into functional occupied areas to implement services “tie-ins”.
• optimising the available space at roof level for the dedicated ventilation plant.

Medical Research Council (MRC) is active in The Gambia as the UK’s single largest investor in medical research in a developing country. The growing demands placed on the MRC’s operations in The Gambia focusing on infectious diseases highlighted the need to review and update the facilities in various locations and make provision for the extended scientific needs of the organisation.
The MRC’s main Unit in The Gambia is situated in Fajara, approximately nine miles from the capital Banjul. The Unit operates over a 100 acre site which consists of research and clinical laboratory facilities (up to ACDP containment level 3). The Unit is also home to the busy clinical services department, the Unit’s biobank, as well as approximately 40 residential units of various sizes.
As well as maintaining existing site services, there is a requirement to add new facilities to continue the MRC’s commitment to leading scientific research. These new facilities will introduce a greater demand on the site utilities, specifically the electrical infrastructure which is the Unit’s primary energy source. The anticipated new facilities are:

• New molecular laboratory (1000m²);
• Biobank extension (160m²);
• New lecture theatre (600m²);
• Accommodation for academy (Two 10 bedroom blocks – 800m²); and
• A Training centre (approximately 1000m²)

Following a number of commissions for the MRC in The Gambia including a review of energy consumption across its sites Austin were commissioned to undertake a survey of the site electrical infrastructure across the unit in Fajara.
MRC approached Austin as they required a survey to be undertaken on their infrastructure in The Gambia.

Austin approached the requirements by undertaking a detailed survey to establish the current electricity demand including identification of peak times in consumption with potential causes. This included:

• Provide a replacement schedule for equipment associated with the electrical infrastructure including respective time frames
• Identify installations which are deemed unsafe or not in accordance with current standards; and
• Identify the required power capacity for the site in order to future proof and ensure reliable power provision for current and planned activities

The survey was carried out over five days with its extent and recommendations limited to the low voltage infrastructure, culminating at the point of isolation within each building.
Detailed recommendations were provided in a report that addressed current and future needs for the unit and the required upgrades. This included the recommendation for installation of new substations that allows connectivity of the proposed developments onto the upgraded infrastructure. This extended to provision of an additional standby generator to overcome manual intervention and reduction in available capacity during periods of simultaneous standby and further upgrades to problematic generators.
Austin subsequently oversaw the implementation phase on site by supporting MRC with procurement, monitoring installation through to final commissioning and into operation.

Austin were commissioned by MRCT and SBC to undertake the concept design and then a preliminary study for the fit-out of the ground floor. This provided additional accommodation for MRCT to relocate staff from another location, and for SBC, a series of lettable laboratory and office spaces based around the “Hotel Concept” for leasing out as short to mid-term research space.

Following this Austin were commissioned to undertake the detail design for incorporating MRCT’s and SBC’s overall requirements into the Accelerator Building.

Austin worked closely with MRCT and SBC to develop the detailed design for all activities and the equipment.

In order to satisfy MRCT’s requirements, accommodation included:

• Material entry and receipt.
• Open plan chemistry laboratory incorporating 18 fume cupboards, prep and analysis areas, a separate NMR room and solvent storage.
• Open plan biology laboratories incorporating mobile/flexible work stations, separate tissue culture, radiological, imaging and equipment laboratories.
• Centralised site services incorporating glass wash, autoclave and consumables storage.
• Open plan and cellular offices with laboratory write-up areas.
• External compound for generator, UPS, gas bottle and waste store.

‘We are delighted with our new facility. Austin’s state of the art design has created a dynamic open plan environment which increases interdisciplinary interactions and allows us t? better harness the problem solving abilities of our employees. The new laboratories and offices enable teams to work more efficiently to push forward potential treatments to patients.’
Dr Justin Bryans, Director, Drug Discovery at MRC Technology.

Ipsen is a global specialty-driven pharmaceutical group selling in excess of 20 drug types in more than 115 countries with an R&D expenditure of around €193 million.
Ipsen’s ambition is to be a leader in specialty healthcare solutions for targeted debilitating diseases. This strategy called for the consolidation of their research in the heart of leading biotechnological and life sciences hubs.
Ipsen had undertaken a preliminary study which sought to define broad proposals for accommodating their Oxford research group, at Milton Park. They then appointed Austin to undertake a critique of these proposals, to develop them into a viable detailed design and to deliver this 2700m² prestigious science facility.

`Austin’s team have delivered a superb new laboratory and office space in which Ipsen’s UK R&D team are now located. From the design process and through the construction Phase, Austin have listened to the needs of the Ipsen team and understood the vision for the new site.  The laboratory requirements were challenging, and yet the construction phase has been completed within eight months, on time to accept the personnel transferring from other Ipsen UK sites.’ – John Chaddock, VP Neurology Site Head, Ipsen Bioinnovation.

Dairy Crest had identified the need for a new QC building to support their cheese manufacturing operations at their facility at Davidstow, Cornwall.

Due to the requirement to have the new facility operational early 2015. Dairy Crest had approached the supplier of a modular, prefabricated building to meet their identified needs.

On receipt of an initial design, Dairy Crest commissioned Austin to undertake a peer review of the design for the new modular facility. This review raised a number of suggestions to reflect the user  equirements and enhance the design to provide an optimum and more efficient layout to match the work flow patterns.

Parallel to this review, Austin reviewed alternative locations for the facility on the Davidstow site, to determine the best location to serve the ongoing manufacturing processes efficiently.

Following  the location study, a preferred location for the new QC building was identified and agreed. This enabled the final design for the new building, with respect to orientation, access, flows  and incoming utilities to be finalised.

The peer review of the original design for the new QC facility undertaken by Austin, identified a number of modifications to enhance the layout and provide a  more economical and efficient building to suit QC operations. Austin were able to draw upon their experience from similar completed QC facilities to test, and then improve the design. This also  included a detailed review of equipment to be incorporated into the new facility, which included detailed equipment layouts, servicing, access and environmental requirements.

Design  enhancements included replanning the internal layout to better reflect people and material flows around the building and physically separating the plant (HVAC) area from laboratory areas to minimise adverse effects on sensitive scientific equipment from vibration.

Following the peer review exercise, Austin were commissioned to undertake the detailed design and construction of the new 260m², single story modular laboratory. Austin worked in close liaison  with the chosen modular building supplier, with the internal fit-out being governed by key dimensions of the modular building units.

Accommodation included staff entry, sample receipt, microbiology (ACDP 2), wet chemistry, instrument and flame free laboratories, together with chemical and consumables stores, office and staff welfare facilities. Austin provided full architectural, mechanical, electrical and structural design together with project and construction management during the build.

“Austin brought a customer focus to our project, listening to our requirements and providing expertise which has added value to the end result. I have been impressed with their ability to deliver, attention to detail and quality of build”. – Paul O’Neill, Procurement Controller, Dairy Crest Limited.

MRC Keneba is a rural field station situated in the Kiang West region of The Gambia and houses the Nutrition Group of the MRC Laboratories in Gambia.

The field station provides out-patient based services, midwifery and nursing care concentrating primarily on maternal and child health.

The station also has research laboratories, clinical diagnostics, data processing, physiology study and obstetrics.

The expansion of research and demand for services has led to the requirement for additional research laboratories and clinical facilities and meeting room facilities, together with new housing  provisions.

The success of the facility has also had an impact on the number of visitors and research students visiting the unit. The meeting facilities also need expansion in order to support this increase in  activity.

Austin architectural, building services and structural team carried out a site inspection and survey and developed the design with the users from concept through to detail design, specifications  and construction information.

The development area within the site is relatively limited so a phased implementation of new and expanded facilities is envisaged. The provision of a new incinerator adjacent to existing  workshops will provide the enabling work.

A new visitor housing unit will occupy the old incinerator site, which will then release space at the front of the side for the expansion of existing laboratory facilities, clinic and data offices. The  expansion of the existing meeting room building forms part of the development strategy.

Existing Research and Clinic upgrade modifications and expansion of the existing ground floor accommodation will create a larger open plan laboratory with access from within the building in  order to reduce contamination from outside.

A new, enlarged delivery suite will be constructed, observation room added and toilet and shower provision increased. GP’s will be provided with separate consulting rooms.

On the First Floor the internal walls to corridor and within offices will be removed to provide a large, light space for the data entry. The first  floor will be expanded to incorporate a tissue culture laboratory and microbiological laboratory.

The existing bungalow adjacent to the laboratory will be re-modelled to provide a larger store for the laboratory consumables, a freezer store, autoclave and glass wash area as well as an office for a  store manager.

Seminar Building: The current meeting room will be extended to meet the increase in demand. The extension will accommodate up to 100 people and incorporate an acoustic dividing wall to  increase flexibility. The offices will be extended in order to move activities from the research building.