Expert Details
Biopharmaceutical Processes
ID: 725921
Ireland
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.
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.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1986 | Degree: BSc | Subject: Biotechnology | Institution: University of London, Imperial College |
| Year: 1989 | Degree: PhD | Subject: Physiology | Institution: Liverpool University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 1995 to Present | Employer: Undisclosed | Title: Director & Owner | Department: |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 1992 to 1995 | Employer: Haden Freeman | Title: Process Specialist | Department: Process |
Responsibilities:He was a lead process engineer and designer involved in bespoke process design and validation of biologics manufacturing plants. |
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| Years | Employer | Title | Department |
| Years: 1991 to 1992 | Employer: ABTEK Biologicals | Title: Technical & Quality Manager | Department: Technical & Quality |
Responsibilities:Responsible for technical management of a small company supplying consumable testing products and diagnostics to hospitals and laboratories. Responsible for product release. |
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| Years | Employer | Title | Department |
| Years: 1989 to 1991 | Employer: IBIS | Title: Process Design Engineer | Department: Process Design |
Responsibilities:Responsible for tech transfer of development processes to full scale manufacturing. Particularly responsible for the implementation of biological processes into a chemical manufacturing site. |
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Additional Experience
| Expert Witness Experience |
|---|
| 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. |
Career Accomplishments
| Associations / Societies |
|---|
| Member of the SGM; Member of ISPE. |
| Publications and Patents Summary |
|---|
| He has 13 publications and 2 lapsed patents |
Fields of Expertise
active pharmaceutical ingredient, aseptic pharmaceutical process validation, bulk drug, chromatography, chromatography applications, Current Good Manufacturing Practice, Good Manufacturing Practice, injectable pharmaceutical product, pharmaceutical engineering, chiral synthesis, contract manufacturing, tablet coating, drug development, pharmaceutical analysis, Food and Drug Administration regulation, tableting, pharmaceutical reactor, peptide synthesis