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 Expert  725921

Expert in Biopharmaceutical Processes

Available for your Consulting and Expert Witness Needs

CO. Kildare
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert has a BSc. in biotechnology from London (Imperial College) & a Ph.D in cell physiology from Liverpool (UK).

Expert has over 20 years experience gained in a wide range of companies in the pharmaceutical and biopharmaceutical fields. He has published papers in recognised trade journals and chaired made presentations to various conferences.


active pharmaceutical ingredient


aseptic pharmaceutical process validation


bulk drug




chromatography applications


Current Good Manufacturing Practice


Good Manufacturing Practice


injectable pharmaceutical product


pharmaceutical engineering

Show Secondary and Basic Areas of Expertise

Year   Degree   Subject   Institution   Honors
1986   BSc   Biotechnology   University of London, Imperial College   Honours 2(I)
1989   PhD   Physiology   Liverpool University   n/a

Work History:
Years   Employer   Department   Title   Responsibilities

1995 to





Director & Owner


He is responsible for delivering specialist services to the pharmaceutical industry. These services include consultancy, project direction, strategy development and developing novel solutions to manufacturing and regulatory issues.

1992 to 1995


Haden Freeman




Process Specialist


He was a lead process engineer and designer involved in bespoke process design and validation of biologics manufacturing plants.

1991 to 1992


ABTEK Biologicals


Technical & Quality


Technical & Quality Manager


Responsible for technical management of a small company supplying consumable testing products and diagnostics to hospitals and laboratories. Responsible for product release.

1989 to 1991




Process Design


Process Design Engineer


Responsible for tech transfer of development processes to full scale manufacturing. Particularly responsible for the implementation of biological processes into a chemical manufacturing site.

Career Accomplishments:

Member of the SGM; Member of ISPE.

Publications and Patents Summary

He has 13 publications and 2 lapsed patents

Selected Publications and Publishers  
 - ECOLAB conference proceedings  
 - VIB conference proceedings 1999  
 - Conference proceedings of Manufacturing Chemist  

Consulting Services:
Selected Consulting Examples:
  • A company had suffered a 40-50% loss in yield for a high value biologic being manufactured at a contract manufacturer, He went to the plant and implemented a program of process characterisation and process implovements which restored production to its original yield value.
  • A company was manufacturing a product for a license holder who was dissatistfied with the level of GMP compliance. He went in to the plant, conducted a full and through review of quality procedures and actual practice on the ground. As a result of the cGMP reveiw and audit, systemic problems were identified in the manufacturers operation, including falsification of records. On presentation of the list of GMP deficiencies, the license holder elected to cancel the contract with the manufacturer and was able to terminate the contract without penalty.
  • A company was carrying out a global business and growing its exports post launch and required a programme and strategy to scale up a biological API manufacture and increase product to the market while reducing the COGS. He went in and provided a programme, strategy and a financial evaluation of the project to deliver increased manufacturing output while delivering significant cost savings on both API and drug product.
  • A compay was building a green field facility in a country with little expertise in Biologics. They required skilled resource to go to USA tech transfer the product form the US and deliver the Process validation and license for a new site of manufacture within a fast track timetable. He went out to the US, integrated with the site team and delivered a winning strategy which met the company programme and broke the previous record of Regulatory dossier submission post Validation for this product from 3 months to 1 month!
  • A large scale steriles manufacturer was experiencing problems closing out the validation of their manufacturing facility. He went in and managed the contarctors and interfaced with teh client quality organisation and drove through the completion of validation and the final approval of documents which had been teh major problem. He is fluent in French and conducted the work in French for the most part.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
1997 Expert witness at an IChemE appointed arbitrators hearing into a dispute between a contractor and a manufacturing company regarding suitability of a biologics purification plant for pharmaceutical manufacture and potential to receive a license. The case was concluded in favour of expert's party.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
1989 to 1995   UK   As a UK citizen he was working in various roles as listed in the summary of work experience for this time period. The work consisted mainly of design, Quality and technical management roles.
1995 to 1996   Belgium   Involved in design, project management & validation of a vaccines production facility. The project language was French. He was involved in reviewing all designs and specifications and in selction and management of vendors from placement of contract through to commissioning & validation.
2000 to 2001   Ireland/Australia   Involved in a series of projects as a technical specialist, particularly a blood fractionation process. He was involved in the design of a purification plant. He performed consultancy work out in Australia auditing the manuafcturing facility identifying key weaknessess in the design & operation of the plant which made it unlikely it would meet FDA regulations.
2001 to 2002   USA   Tech transfer assignment. He was involved in a team role in a director role, managing the tech transfer of process knowledge from US to Ireland. He focussed on obtaining a full tech transfer package for Process and cleaning validation and assisted the process development department in obtaining a full tech transfer package required for the new site of manufacture
2008 to 2008   Japan   Brief visit to Japan to solve a problem with a direct compression product that was licensed from Europe to Japan for manufatcure to the Japanese market. He resolved issues with dissolution and stability failures which were caused by incorrect blending.

Language Skills:
Foreign Language   Description
French   He is fluent and can conduct meetings and business in this language.
Spanish   Rusty knowledge, reads better than speaks, but can reactivate if required. He learnt Spanish in 3 weeks prior to a trip to Spain in 1987.
Italian   Sufficient to visit the country and read documetation from vendors supplied without English translation.
German   Rusty. Learnt German at school. Work in Europe has kept it working. Limited ability used mainly during visits and for reading documentation supplied only in German.

Market Research:
Contributed at senior director level to the programming and direction of a new site of manufacture for a large volume biological product. Project capital value $2.0 Billion. Was responsible for forming the strategy and implementing it to deliver the Process & Cleaning validation for the bulk drug substance manufacturing plant. This included managing and delivering the data and substance for the regulatory summaries required for the regulatory authority within tight deadlines. Involved in planning, managing and advising global supply chain of biologics products for a customer to allow scale up of product supply and reduction in COGS

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:

Training seminars for Courtaulds engineering in Biotechnology; Training seminars for Loctite in basic GMP compliance; Conference chairman & speaker at international conferences in London & Brussels; Speaker at conferences in USA and Croatia; Currently External lecturer for ITT Dublin for Higher Diploma in Pharmaceutical Production.

Supplier and Vendor Location and Selection

Vendor selection has been a key focus of his work for many years now (1992 to date), he has participated in the selection of vendors for pure water systems, CIP, bioreactors, centrifuges, ultrafilters, etc. These activities have been carried out in many locations including the UK, Ireland, France, Belgium, USA.

Other Skills and Services

Involved in cGMP auditing and regulatory compliance; recent work resulted in a successful termination without penalty, of a contract for supply of drug substance to a customer based on the detailed report of cGMP breaches provided to them. Process review and evaluation work is an area of expertise he offers, in particular, insupport of acquisitions, he can review manufatcuring facilities and license constraints and advise clients on potential value and problems associated with the product and processes prior to acquisition, and imporvements post acquisition.


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