SECOND EXPANSION IN 3 YEARS We are delighted to announce our increased footprint in Cork and Dublin by expanding our office capacity.

We will be occupying second floors in early Summer adding an extra 3500 sq. ft allowing us to reach our target of 150 seats across both locations. Our new office fit outs will feature top-class amenities including smart and interactive technologies, conference rooms and vast collaboration space.

This second expansion in three years signifies our continued growth and development across Ireland, UK and Europe and supports our strategic growth plans.

Part of our reasoning for expansion is increased project

capacity. We experienced a busy but rewarding 2018 delivering multiple projects nationally and internationally which you can read about below while bringing our client portfolio to over 35.

The expansion will also allow us to increase headcount and continue to deliver consistent quality, personal service and attention to detail that our clients have come to expect.

Finally we would like to take this opportunity to officially congratulate our team and client Eli Lilly on their recent ISPE FOYA win. This is a large international recognition so well done to all on this achievement.

BPE INSIGHT

Newsletter May 2019

1 BPE Insight

S TAT I S T I C S + € 200M Capex projects delivered acrossRepublic of Ireland, Northern Ireland,Mainland Europe and Russia in 2018

L AT E S T P R O J E C T T Y P E SSuccessfully Delivering Projects to our clients across R&D, API, OSD, Secondary Packing, BioPharma, Fill Finish.

Ireland - €110M

Uk / Northern Ireland - €50M

Mainland Europe - €40M

Sterile, Aseptic Laboratory & Filling projects

Multi-product, small scale, high containment Peptide Facilities

Continuous Manufacturing Designs

High Containment Infrastructure Developments

New Builds from Concept, Planning to Construction

Product Transfers form UK to Ireland

International Project Delivery

Engineering Design and Project Delivery

Newsletter May 20192

H I G H CO N TA I N M E N T P R O J E C T S W I T HB I O P H A R M A E N G I N E E R I N G

BPE has deep insight and multiple references into high containment sterile manufacturing projects. We have first-hand

experience operating in fill-finish environments, extensive knowledge of regulatory developments (Annex 1), practical

experience integrating different filling technologies and awareness of the industry’s most recent developments.

Our expertise has allowed us to execute projects in sterile, aseptic and containment environments recently undertaking several sterile injectable facility projects.

High Containment OEB6 Lab Scale Suite - €10M Sterile Injectable Facility - €35MrFSH and Peptides Facility - €30M High Speed Aseptic Filling RABS - €10M

Automation for high speed filling and robotics

Annex 1 revision of WFI states it must be produced from purified water instead of drinking water. The EU Pharmacopoeia also recommends the use of reverse osmosis to produce WFI, but regulators prefer distillation

Desire for flexibility is growing to help anticipate future format, packaging and filling needs

Filling Line Delivery 18-22 Months

Peptide Purification Suite - €25MSterile Antibiotic Injectable Facility- €10MNew QC Sterility Labs - €5MNew Compounding Suite - €20M

O U R E X P E R T I S E I S AC R O S S :

R E C E N T P R O J E C T S

K E Y I N D U S T R Y T R E N D S

PEPTIDES (Extraction, Purification and Lyophilisation)

HIGH CONTAINMENT (High Potency / ATEX /

Isolators)

PLUG AND PLAY (Skid Build for Future

Optimisation)

FUME-HOOD PROCESSING (Segregation/

Mitigation)

RABS (Sterile / Aseptic Processing)

RABS VS ISOLATOR DESIGN

IsolatorEnvironment D Over pressureComplexity: Highest, due to transfer techniques and bio-contamination Comfort: Medium, no clean room garment but some restrictions Aseptic Quality: Highest SAL~10-6 Weeks Multiple batch filling possible

Open Rabs/Closed Rabs Environment B No overpressure to surroundingsComplexity: High, due to transfer techniques and restricted access by gloves Comfort: Even lower due to clean room garment and restricted access Aseptic quality: Slightly improved SAL-10~10-4 Several days multiple Batch filling unusual

VSVS

3 BPE Insight

NEW INJECTABLE STERIL ITY SUITE

Client: CONFIDENTIAL

CONCEPT - BASIS OF DESIGN - DETAILED DESIGN

Cost: €6M

Location: UK

Duration: 6 MONTHS

C A S E S T U D Y

KEY DESIGN CONSIDERATIONS

RTP connections, cleaning, equipment disassembly, maintenance - key risk points.

3D visualisation/mock-ups with isolator vendor for ergonomic design is key success factor and adoption of design.   

Containment philosophy needs to be specific with each material transfer into/out of isolators fully assessed.

Risk assess and eliminate hazardous zones where possible.

Basis of safety – key controls are procedure, operator training, routine IH monitoring to assess performance.

Automation integration – networking of TCUs, pluggable instrumentation, paperless batch recording.

To discuss your needs please contact Aisling Crowley, Client Relationship Manager on +353857441155

New aseptic GMP facility, to

be housed in an existing retrofitted

building

Specification and Procurement of new filling

line, sanitisation booths,

manufacturing/mixing vessels and process instruments

Civil and Structural, Process,

Mechanical, I&C design to increase

batch size by 20% and fill 200 syringes/minute

Multiplestakeholder

inputs

Live ProductionFacility

Strategic Site Investment

CORK OFFICE NSC Campus Mahon Mahon, Cork, Ireland

T: +353 21 2307120E: info@biopharma.ie

DUBLIN OFFICE Unit D, Westland Business Park Willow Road,Dublin 12, Ireland

T: +353 1 4607250E: info@biopharma.ie www.BioPharma.ie

BPE was recently awarded the EPCMQ Contract for a global dermatological healthcare provider in Dublin. The scope of the project will see production on-site increase capacity. The new build suite requires a capacity of 4 tons/5500 L and will require an extension to the existing building. BPE completed the concept design and basis of design and will continue to develop the Detailed Engineering, Project management, construction management and C&Q to provide full EPCMQ services.

BPE are delighted to announce our recent partnership with a Swiss based pharmaceutical giant who specialises in products in the fields of reproductive health, urology, gastroenterology, endocrinology, and osteoarthritis. Having recently completed the concept study for the new API facility in Russia, BPE also supported our client with a feasibility study for new peptides and rFSH in their production facilities in Russia.

BPE were recently engaged by our client to deliver a concept study to secure a capex investment of €35M to support the full end to end production and packing of a new introduction of a sterile injectable syringe product.

C L I E N T S P OT L I G H T

Reputation, Recognition and Reinvestment

BPE was recently awarded EPCMQ contract for a Site Capacity Increase and Expansion

BPE partners with Swiss based Pharmaceutical Giant

BPE Delivers Concept Study to secure capex investment of €35M

Engineering Design and Project Management Partner for 2019 FOYA category winner

Corporate Livewire Consultancy Firm of the Year

Finalist for Pharma Project of the Year Large 2018

STEAM Education Sponsorship

€5k Charitable Donations 2018

Office Expansion-Cork and Dublin 2019

New Graduate Programme Launched 2019

15 New Senior Hires 2018

New HR System for training and development

Cork Institute of Technology Student of the Year Sponsorship 2019