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
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:
and cost study for a biomanufacturing project UK
biopharmaceutical manufacturer (Cobra) (2007-8)
Lead on the detailed design phase of a biomanufacturing
project for a European biopharmaceutical Company (UCB). Total value approx €200m (2005-2007)
design and costing for pilot and small scale manufacturing facility for a UK
cancer vaccine company (Biovex, 2004-2006)
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
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)
of manufacturing cost estimates of a proposed large scale operation for a new
biopharmaceutical for Celltech Chiroscience Plc
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)
Officer for UK Dept of Trade & Industry
Collaborative R&D projects (2006 onwards)
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).
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).
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).
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
to EU GMP of an Indian biopharmaceutical manufacturing facility (Andra Pradesh, 2006)
of 3 medical device component suppliers on behalf of Provensis
(UK, France, Belgium 2004-2005)
to Q7A of a Chinese API manufacturer on behalf of a UK company (Taiwan, 2003)
to EU GMP of manufacturing facility at Avecia Life
Science Molecules, Billingham (2001)
of Clinical Trials manufacturing facility prior to inspection at Medeva (1999)
of Sterile facilities using HACCP methodology at Delta Biotechnology (1995)
of Development plans, VMP and technology transfer protocols for a novel
vaccine at a CMO on behalf of Microscience
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)
of Validation Master Plan and validation project management for Powderject Pharmaceutical (2003)
planning services for the preparation of a biopharmaceutical BLA (Celltech
of qualification and validation for monoclonal antibody manufacturing plant
extension at Celltech Biologicals Plc (now Lonza Biologicals) (1993).
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).
· Preparation of maintenance documentation for a biopharmaceutical manufacturer (Viragen, 2000)
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
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:
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).
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).
of preliminary development of a Product Licence
Application including preparation of reports and investigation of revision
control methods (Medeva)