Thomas A. Jennings, Ph.D., is an expert in vacuum technology and lyophilization. His work in low temperature properties of formulations, the development of the lyophilization process, the performance characteristics of dryers is particularity noteworthy. Dr. Jennings has focused on lyophilization for more than 25 years. He worked for several years for one of the largest manufacturers of freeze-drying equipment before founding his own company in 1978. He formed a new firm, Phase Technologies, Inc., in 1990, with the vision of transforming lyophilization from an art to a science.
Dr. Jennings holds a Ph.D. in physical chemistry from the University of Aston, Birmingham, England and a BA and MA in chemistry from Temple University. He has been awarded numerous patents and is the author of more than 20 technical publications involving the lyophilization process and freeze-drying equipment and instrumentation. He received the Fred Simon award for the outstanding technical paper published in the PDA Journal of Pharmaceutical Science and Technology for 1995. He is the author of the book Lyophilization - Introduction and Basic Principles published by Interpharm Press in 1999. He continues to publish on the above web site, on a monthly schedule, a technical publication (INSIGHT) that is related to the lyophilization process, its equipment, instrumentation and validation.
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Miquel Galan is Director of Innovation and Research Development of TELSTAR INDUSTRIAL in Spain. He has been with Telstar for over 19 years. He is an expert in vacuum technology, leak detection and pharmaceutical engineering. He has held a position as a Process Engineering Manager, and has managed many large freeze drying projects.
He holds degrees in Chemical Engineering from the Instituto Químico de Sarrià (IQS) and Industrial Engineering from the Universitat Ramon Llull. He is a Member of PDA (Parenteral Drug Association) and of ISPE (International Society of Pharmaceutical Engineering). He has lectured on many freeze drying courses as well as other topics about vacuum related subjects over the past fifteen years.
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Lawrence A. Ulfik is Regional Manager at Virtis Company. Larry Ulfik was introduced to freeze drying and low temperature refrigeration and drying technology, light scattering, amino acid analysis, aerosol photometry, fermentation and homogenization, when he started his career as a technical advisor, at Virtis Company. He worked at the United Nations as a consultant in vaccine production and freeze drying in Mexico City, and trained many individuals in the methodology of freeze drying and others in the maintenance and installation of laboratory and production systems. As sales manager at FTS systems he was instrumental in developing OEM accounts applying their micro sized cooling systems to auto analyzers and differential scanning calorimeters and developed the market for their freeze drying systems. He was instrumental in introducing PLCs into freeze drying systems, and introducing computerization into the estimation process in the USA as sales manager at Hull Corporation. His practical knowledge was implemented as the freeze drying director at Microlife-Technics, a company producing natural biotech cultures for foods and environmental remediation where he helped to design the freeze drying production facility and lyophilization cycles, and installed and used an 84 square foot steam-in-place freeze drying system. He was regional manager at Edwards High Vacuum and responsible for the USA sale of the first liquid nitrogen assisted system having a 1000 square foot shelf area and many other systems as applied to the pharmaceutical and diagnostics industries. Larry has been course leader in numerous freeze drying courses, is a member of and has presented at the Parenteral Drug Association and at poster sessions as well as the ISPE. He continues his work in freeze drying as regional manager at Virtis, where he is responsible for the east coast sales of laboratory and production freeze drying systems and for cycle development and initial freeze drying customers products on a laboratory scale, as well as in training Virtis customers and representatives.
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Several years of experience in international pharmaceutical industry. Started as department head in production change to project leader in several development functions. During all the time concerned with outsourcing regarding contract manufacturing, packaging, distribution of clinical supplies, contract development and insourcing. Well familiar with freeze drying based on the thesis in sterile dosage forms and the actual lead of the development of a new freeze dried antibiotic medicine. Due to several years experience in outsourcing well familiar with the process, adequate contracting, authority requirements, hurdles and solution
Professional background
1995 - 1996 Pharbil Pharma GmbH 33605 Bielefeld (form. Rhone - Poulenc Rorer)
Department Head
Deputy responsible person for production solid, semisolid and liquid dosage forms. Management of packaging operations in close cooperation with galenical production. Management and supervision of qualification and validation of equipment and processes. Transfer of external projects into galenical production and packaging.
1996 - 1999 Gödecke AG, Parke - Davis 79090 Freiburg
Project Leader CPO Int'l (RD)
Responsibility for planning and management of medication for international clinical trials. Lead and supervision of strategic outsourcing projects.
1999 - 2002 Novartis Pharma AG Ch-4002 Basel/ Switzerland
Project Leader in Technical Research and Development
Responsibility in different functions for transfer and validation of different development projects and processes from research to production Coordination, contracting and steering of external collaborations and contribution in due diligence evaluations.Technical project leader for external development projects.
Since June 2002 Basilea Pharmaceutica Ch-4002 Basel/Switzerland
Manager Pharmaceutical Development
Overall responsibility for pharmaceutical development, clinical supplies manufacture and market supplies manufacturer identification, contracting and supervision for different medicines in development.
Education Studies of Pharmacy at the University of Heidelberg
PhD in pharmaceutical Technology in 1994
Publications
Karbstein H., Schubert H., Scigalla W., Ludwig H., (1992), Sterilization of emulsions by means of high pressure, High Pressure and Biotechnology, Colloque Inserm, J.L. Eurotext Ltd.Vol 224, 345-347.
Ludwig H., Bieler C., Hallbauer K., Scigalla W., (1992), Inactivation of microorganisms by hydrostatic pressure, High Pressure and Biotechnology, Colloque Inserm J.L. Eurotext Ltd., Vol 224 25-32.
Ludwig H., Gross P., Scigalla W., Sojka B., (1994), Pressure Inactivation of microorganisms, High Pressure Research, Vol. 12, pp. 193-197, Gordon and Breach Science Publishers S. A.
Scigalla W. (1992), Mechanical stress at high pressure treated samples, University course for high pressure pasteurisation, University of Heidelberg.
Scigalla W., Ludwig H., Sterilization of radiation and thermosensitive pharmaceutical materials by means of high pressure, Books to EHPRG Annual Meeting, Brno (1994).
Hobbies Music: piano, accordion, guitar.
Sports: paragliding, skiing, tennis, walking.
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Born and raised in the UK.
Started with BOC Edwards in 1977 - 25yrs now with BOC Edwards Obtained degree in electrical and mechanical engineering in UK Moved to the States in 1981 with Edwards Have held the following positions within Edwards since moving to the States;
Service technician - leak detectors and thin film deposition systems
Service Manager - Grand Island Facility
Business Development Manager - measurement test & control
U.S. Engineering Manager
Product Manager - leak detection
BOCE Global account Manager for Lam Research Semiconductor
Western Regional Sales Manager - General Vacuum Group
Business Development Manager - General Vacuum Sector
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Education
BSc Chemistry
University of Liverpool 1974
BSc (Hons)
Biochemistry University of Liverpool 1975
PhD Pharmacy
University of Aston 1980
Relevant Employment
Edwards High
Vacuum 1987-92 ( Freeze Dryers, Fedegari autoclaves, Stilmas PSGs)
Biopharma Process
Systems 1982-87 (Usifroid, VirTis)
Steris 1987 - 2000
(Freeze Dryers, autoclaves, PSGs)
Bovis Lend Lease
2000 - todate (Steriles consultancy)
Relevant Work Experience
33 FD
consultancy projects
7 consultancies
specifically on freeze dryer sterilisation issues
17 Steriles Concept
Design Studies
76 freeze dryer
installations
Several GMP audits
31 customer house
FD courses
Publications
Textbook
co-author “Good Pharmaceutical FD Practice”
6 UK Parenteral
Society monographs (co-author) including “Sterilisation of Freeze
Dryers”
8 FD articles
3 Poster sessions
ISPE/PEAT textbook
in progress
Conferences
Management
Forum Lyophilisation Course (annual)
ISPE Lyophilisation
course chair
ISPE Courses
UK Parenteral
Society courses and conferences
Memberships
UK Parenteral
Society
Parenteral Society
Lyophilisation group
PDA
ISPE
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