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About Rotherwood Associates

Bill Thompson
Lynne Thompson

Rotherwood provide services in the following areas.

• Technical consultancy  on the setting up or modification of development, pilot or manufacturing facilities including design, validation and operational aspects. 
• Assistance in the drug development process, including CMC document production and review
• Project management of small projects to either lead or support in-house teams
• Client representation on larger projects or to provide oversight to third party contractors
• Assessment, setting up and management of outsourcing to CMOs including technology transfer documentation and management

Bill Thompson BSc, MSc, CEng, MIChemE

After obtaining degrees in biochemical engineering and food technology, Bill Thompson joined the APV Company Ltd working in process development and project engineering.

He joined Celltech Ltd where he managed the Process Engineering Department and was responsible for engineering and installation of all fermentation and downstream processing systems as well as the construction of a complete 40,000 sq.ft. production facility. This included the management of the validation exercise leading to a successful FDA inspection.

He then joined OROS Systems Ltd as Operations Director where he was responsible for design, manufacturing and quality assurance of the company's range of automated chromatography systems.

He is currently a Consultant with Rotherwood Associates. Recent projects have included:

Project Management

·       Monitoring Officer for UK Dept of Trade & Industry Collaborative R&D projects (2006 onwards)

·       Project management of the outsourced manufacture of a parenteral drug delivery device. Includes management of development, documentation preparation and review, validation, material sourcing, manufacture and QC activities (Provensis, 2001-2004).

·       Project management services in the field of regulatory and quality compliance systems for a major biopharmaceutical contract manufacturer. Included methods of producing regulatory submission documents, systems for handling QC data and introduction of new disinfectants (Lonza Biologics, 2000-2002).

·       Project Engineering of a series of regulatory compliance projects for a small biopharmaceutical manufacturing facility in the UK (Delta Biotechnology) including clean room facilities and process equipment design and installation from conceptual design through validation (1994 and 1996-1997).

·       Management of a design study and process development programme of a biologicals production facility for a small research based company (Therapeutic Antibodies Ltd). Project included some scale-up development of the laboratory process to purify polyclonal antibodies from sheep's serum (1992-1993).

 Design Projects

·       Process Lead on the detailed design phase of a biomanufacturing project for a European biopharmaceutical Company. Total value approx €200m (2005-2007)

·       Concept design and costing for pilot and small scale manufacturing facility for a UK cancer vaccine company (Biovex, 2004-2006)

·       Consultancy assignment to provide process design and validation input to new large scale vaccine production facility on behalf of a development department (Medeva) and liasing with main contractor. Involved coordinating development input, reviewing and agreeing detailed process design and validation protocols and monitoring contractor’s performance (1996-2000).

·       Design and process scale-up consultancy for a new vaccines facility for a major biopharmaceutical client in Belgium (Smithkline Beecham Biologicals). Commenced with a study and estimate and followed by detailed design and engineering liasing with the main contractor. Total value approx £15m (1994-1995)

·       Preparation of manufacturing cost estimates of a proposed large scale operation for a new biopharmaceutical for Celltech Chiroscience Plc (1998).

·       Design and scale-up study and cost estimate for an upgrade to an existing biological primary manufacturing plant in Spain (Cyanamid). Total value approx £4m (1994)

Audits

·       Audit to EU GMP of an Indian biopharmaceutical manufacturing facility (Andra Pradesh, 2006)

·       Audit of 3 medical device component suppliers on behalf of Provensis (UK, France, Belgium 2004-2005)

·       Audit to Q7A of a Chinese API manufacturer on behalf of a UK company (Taiwan, 2003)

·       Audit to EU GMP of manufacturing facility at Avecia Life Science Molecules, Billingham (2001)

·       Audit of Clinical Trials manufacturing facility prior to inspection at Medeva (1999)

·       Audit of Sterile facilities using HACCP methodology at Delta Biotechnology (1995)

Drug Development/Validation

·       Preparation of Development plans, VMP and technology transfer protocols for a novel vaccine at a CMO on behalf of Microscience (2002-2003)

·       Part of a team to manage process and facility validation project by a CMO on behalf of Cambridge Antibody Technology and to assist in preparation of CMC section of BLA. (2002-2004)

·       Preparation of Validation Master Plan and validation project management for Powderject Pharmaceutical (2003)

·       Project planning services for the preparation of a biopharmaceutical BLA (Celltech R&D, 1995)

·       Planning of qualification and validation for monoclonal antibody manufacturing plant extension at Celltech Biologicals Plc (now Lonza Biologicals) (1993).

Outsourcing Management

·       Search, specification and negotiation with a large scale contract manufacturer and contract development laboratory for a biopharmaceutical leading to preparation of development and process validation plans (Celltech, 2001-2003).

Miscellaneous

·       Preparation of maintenance documentation for a biopharmaceutical manufacturer (Viragen, 2000)

·       Numerous small projects for Pharma/Biotechnology companies (including Pharmaceutical Proteins Ltd (1989), Detoxx Ltd (1993), Bioseparations Associates Ltd (1990), Medeva Plc, Biocompatibles Ltd (1992), Sauflon Pharmaceuticals Ltd (1990), K&S Biomedix in the field of process scale-up, economic evaluation of projects and feasibility studies.

Lynne Thompson PhD

Lynne obtained her first degree in Biochemistry followed by a PhD also in Biochemistry from Georgia Tech.

She then spent 3 years as as Postdoctoral Research Assistant to Professor Sir Hans Kornberg at Cambridge University before joining Celltech in the Downstream Processing Group responsible for various immunopurification and process development projects. She moved to manufacturing as a project manager with responsibility for various contract manufacturing  and validation projects

Since 1991 she has been a Partner in Rotherwood Associates. Assignments have included:

• Planning and documentation services for a virtual pharmaceutical company covering development and manufacturing activities. Included preparation of manufacturing documents and management of some outsourcing activities.

• Management of outsourcing contract for the secondary production of a novel parentral drug product (Renovo). Included review and approval of all documentation and resolution of technical queries.

• Successive customer audits of a contract development and testing laboratory on behalf of Antisoma.

• Management of several outsourcing contracts for the vialling and testing of a range of biopharmaceutical products.  Included coordination of the suppliers with each other and the client as well as with other suppliers in the manufacturing train (Celltech).

• Provision of project planning service for the development of a new biopharmaceutical vaccine project. Included developing project plan and measuring progress achieved by the project (Medeva).

• Set up of a GMP training programme for a small biotechnology manufacturing company (Delta Biotechnology).

• Management of a pre-clinical vaccine development programme including process development, assay development and animal studies. Included planning of clinical programme through to product launch (Medeva)

• Development of a document control systems for a biopharmaceutical manufacturer, including both production procedure documentation and engineering drawings. Development of control procedures and computer database records systems (Celltech Biologics).

• Management of preliminary development of a Product Licence Application including preparation of reports and investigation of revision control methods (Medeva)