elan drug technologies’ manufacturing services€¦ · – wet granulation (high shear and fluid...

Elan Drug Technologies’ Manufacturing Services General Presentation – Capabilities Overview

December 2010

2Elan Drug Technologies © 2010www.elandrugtechnologies.com

Elan Manufacturing Services | Who We Are

Elan Manufacturing Services is a global business that provides product development and manufacturing services to the pharmaceutical market and is part of Elan Drug Technologies.

Building on our process development expertise we provide drug product optimisation, scale-up and manufacturing services in solid oral dosage forms. With over 40 years in the service business, we have proven expertise in drug product development, process design and process improvements. We have a blue chip client list including 7 of the top 10 world pharma companies.


Elan Manufacturing Services | Collaborative Approach

– Experience and Expertise • 40+ year history in business with strong track record

– The industry trusts us • 30+ leading pharma companies as clients

– Wide Range of Services sets us apart• Effective, robust and efficient technical transfers • Range of proven and validated technology and process improvement solutions • Modern Facilities with Best in Class Systems• Competitive pricing • On-time delivery record• Exceptional compliance track record • Excellent Environmental, Health and Safety Record

– # 1 drug technology company worldwide • Proven drug optimisation capabilities with 12 products developed and launched since 2001

– FDA/EMA-licensed sites in both Europe and U.S.

Why Work With Us ?


– Speed to Market • Proven efficiency with on-site development, technical and manufacturing services to provide a fast efficient service• Capability to design, build, commission, qualify and commercialise any solid oral processes on-site

– Compliant, reliable and cost efficient supplier• Excellent compliance record in US and Europe with experienced and motivated staff• Flexible infrastructure and efficient operations with mature Lean 6 Sigma/Operational excellence programme

– Effectiveness of Transfer • We leverage our product and process understanding, risk assessment methodologies, process modelling and optimised experimental

approaches to maximise transfer effectiveness• We work to ensure transferred processes are robust and capable. • Process documentation, QA systems, calibration and maintenance activities are targeted towards key process variables/steps (i.e.

waste elimination and error proofing by design)

– Dedicated Customer Service • We believe in the importance of open communication• A dedicated project management resource to keep you informed at all stages in the project/commercial supply arrangement

Our Promise to our Clients



– Access to full capabilities of our sites• Capacity of 2.5B solid dosage units, Process and analytical equipment, DEA controlled site, packaging facilities for US

and EU

– Access to strategic solutions to extend life of your product • Technology expertise – Bioavailability enhancement and Oral Controlled Release platforms • Proven Life Cycle Management Strategies• Intellectual Property portfolio of 1,900 patents/filed patents and expertise• Full CMC package capabilities for regulatory submissions

– Opportunity to examine Tax options• Location in Low Tax Jurisdiction (LTJ) for Ireland facility

– Process Optimisation post-launch• Availability of small scale process equipment to evaluate process changes such as alternate API suppliers, material

changes and additional strengths.


Our Promise to our Clients


The Industry Trusts Elan Drug Technologies

Successful collaborations with many of the world’s leading pharmaceutical companies.

Successful collaborations with more than 30 of the world’s leading pharmaceutical companies for development and/or scale-up & manufacturing.

Successful collaborations with more than 30 of the world’s leading pharmaceutical companies for development and/or scale-up & manufacturing.


Elan Drug Technologies | Key Activities

Elan Drug Technologies


Elan Drug Technologies

Our Wide Range of Services Sets us apart

• Highly skilled work-force seasoned in product development • Broad range of technology solutions from solubility enhancement to controlled release • 270,000 sq ft of cGMP facility worldwide • On-site tech transfer to commercial manufacturing• Experience, proven track record, infrastructure and capacity in solid oral dosage form manufacture – 2.5 billion units annually• Excellent compliance record • Fully compliant FDA/EMA/JMHLW GMP facilities• 40 years experience in pharmaceutical product development• International expertise, manufacturing and exporting to 96 countries including India and China


Our Development Capacity

– Since 2001 we have developed 12 products which have been launched in the US and international markets.

– We have over 160 scientists of which 30 are PhD scientists with the majority of our staff having 10+ years pharmaceutical experience.

Pfizer

Acorda(Ampyra®)


From Initial Development through Commercial Manufacturing


Lean 6 Sigma /Operational Excellence Initiatives – Driving Excellence in everything we do

Operational Excellence Initiatives • Trained Problem Solvers (Black Belts, Green Belts & Yellow Belts) who anticipate, overcome and

improve workflow challenges• Value Stream Structure• Standardised Workflows• Process Mapping• Improved Set-Up/Turnaround Times• Lean Lab• Energy Conservation


Our Legacy of Quality

• Demonstrated by Successful Inspections from:

– Food & Drug Administration – Irish Medicines Board – Environmental Protection

Agency – Health & Safety Authority – Client and Consultant Audits

• Inspection Ready Status and Continuous Quality Improvement reinforced by extensive self-inspection program and corrective and preventative action database

“ There is a culture of Building Quality into all we do at EDT and this message is continually reinforced at all levels in the organisation. We have an excellent compliance record with regulatory agencies including EMA and FDA where for example the Gainesville plant has enjoyed zero 483’s in its last three successive inspections”- VP and Head of Quality at EDT


Elan Drug Technologies CampusAthlone, Ireland

Athlone, Ireland Facility

Located on 40 acres site, the facility has approximately 505,000 square feet of space

Operates under cGMP standards

FDA/EMA Licensed

Formulation through scale-up and full scale manufacturing

10 different products are manufactured and/or packaged at this site at present. Manufactures product for US, European and Asian markets

The facility has an equipped capacity of 2 billion unit solid oral doses


Elan Drug Technologies facility, Gainesville,Georgia, USA

Gainesville, GA, USA Facility

Located on 148 acres of land, the facility has approximately 87,000 square feet of space

Includes 288 pallet vault built in accordance with DEA specifications.Operates under cGMP standards.Two-level facility.

FDA/EMA/DEA Licensed

Formulation through scale-up and full scale manufacturing

10 different products are manufactured and/or packaged at this site at present. Manufactures product for US, European and Asian markets

The facility has an equipped capacity of 500 million unit solid oral doses


Modern Solid Oral Dose Facilities to Fit Clients Precise Product Requirements

Including:– Milling– Screening – Blending – Wet granulation (high shear and fluid

bed) for solvent and aqueous processing

– Bead coating (organic solvent and aqueous based) using Wurster FBP, CF granulation and pans

– Tabletting – Film coating and sugar coating – Encapsulation (powder, bead, dual fill)– Finished product packaging

(bottle/blister/vial) including cold chain capability

– Controlled Substance manufacture– Release testing – EU QP Service

available for US clients doing business in Europe


Analytical Services

• We offer a complete range of analytical capabilities to support your requirements – be that technology transfer, scale-up, clinical trial supplies or full scale commercial manufacturing.

• Working in our dedicated 72,000 square feet of laboratory space, we have at present, over 60 projects in the development process.

• Our highly qualified chemists and scientific staff operate in fully equipped, best in class facilities that include:

– Raw Material, In-Process and Finished Product release testing laboratories

– Microbiology laboratories– Bioanalytical laboratories– Stability incubators and testing facilities– Method Development laboratories– Method Validation laboratories


Environmental Health and Safety Programs - imbedded safety culture and continual improvement ethos

Audited Safety compliance

Integrated EHS management system, regularly audited

Fully compliant and comprehensively audited ATEX programme

Extensive on site technical EHS expertise and experience

Environment waste and energy program

Lower Tier Seveso II site - zero non-conformances during 2009 HSA audit

IPPC licensed with a proven track record of maintaining compliance

Hygiene programs and Occupational Health programs

Robust risk assessment and industrial hygiene systems

Strong EHS performance:

– Priority focus on proactive reporting and elimination of hazards e.g. “Good Saves”

– 2009 OSHA recordable rate = 0.7 per 100 workers (or 0.35 per 100,000 hours worked)

Capability of handling low MIE materials and potent compounds Company Code of Conduct for all employees

Upon joining the company, all staff sign up to agreeing to run the business in an ethical and compliant fashion.


Case Study 1:Large Pharma Supply Manufacturing Services - 5 year OTIF>95%

Robust process development and transfer in significantly less than Large Pharma’s best case time estimate for project

5 years trouble free supply with OTIF consistently > 95%

Process & product improvement initiatives that have delivered or demonstrated potential to deliver significant capacity and yield improvements

Combined cycle – capacity increase arising 22% - implemented in client’s own facilities

Process improvement where an increasing return on active was achieved- 25% increase in API yield per batch, resulting in client savings of $1M+ per annum

Increased active loading of bead (with reformulation) - capacity increase arising 35.5%

Process scaling – Right First Time (RFT to Glatt 5 & 30)- Enabled further optimisation and cycle development at small scale away from commercial cGMP

& cost constraints associated with large scale processes



– Experience and Expertise • 40+ year history in business with strong track record

– The industry trusts us • 30+ leading pharma companies as clients

– Wide Range of Services sets us apart• Effective, robust and efficient technical transfers • Range of proven and validated technology and process improvement solutions • Modern Facilities with Best in Class Systems• Competitive pricing • On-time delivery record• Exceptional compliance track record • Excellent Environmental, Health and Safety Record

– # 1 drug technology company worldwide • Proven drug optimisation capabilities with 12 products developed and launched since 2001

– FDA/EMA-licensed sites in both Europe and U.S.

Why Work With Us ?


Elan Drug Technologies | Contact Us

For more information go to our website www.elandrugtechnologies.com/manufacturing

Top Drug Delivery Company of the Decade-Drug Delivery Technology Survey, May 2010

Philip PrattenVP, Manufacturing Services [email protected]: +353 9064 95590

General queries: [email protected]

elan drug technologies’ manufacturing services€¦ · – wet granulation (high shear and fluid...

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