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Kevin Smith

Technical Director

Kevin joined Biopharma in 1993 as senior service engineer, later becoming Technical Director, before retiring in 2018. Over those years he helped build a strong service department responsible for the installation, site acceptance testing and qualification, together with the ongoing technical support of a wide range of machines, ranging from the small bench-top laboratory machines to very large fully automated production equipment. Most of the customary documentation, maintenance and qualification protocols were written by Kevin in association with Biopharma’s previous Technical Director, Richard Wood. He also updated the ISO9001: Quality Management System for Biopharma Process Systems Ltd.

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Kevin Ward

Director of R&D

After graduating with a BSc in Chemistry and being attracted by an advertisement for a PhD studentship in pharmaceutical freeze-drying at Aston University in the UK, Kevin Ward began his career in lyophilisation in 1993. His PhD included studies on protein stabilisation; the preparation, loading and preservation of “stealth liposomes”; and the thermal properties of lyophilised amorphous and crystalline mixtures. Following his PhD, Kevin worked in the pharmaceutical industry and in vaccine development, before joining the Biopharma Group in 2000 and, as Director of R&D, he has built up a team of dedicated freeze-drying scientists. Since that time, Kevin and his team have had experience of more than 2,500 unique projects for over 500 client companies worldwide, developed 3 analytical instruments, run more than 400 training courses, and successfully secured EU- and UK- government funding for 15 novel research projects. He has appeared on BBC television for his team’s work on the preservation of red blood cells and been an advisor to the BBC for one of their popular science shows. Kevin is a Fellow of the Royal Society of Chemistry and a member of the Academy of Pharmaceutical Sciences. From 2000-2014, he was part of a not-for-profit focus group that produced a large number of technical monographs to support users of freeze-dryers, and he chaired the group from 2007-2014. He has been industrial supervisor to two doctoral students, an external examiner and a Visiting Lecturer at University College London and University of Sussex Pharmacy Schools in the UK. An author of numerous papers, book chapters and patents, Kevin continues to lecture on the international stage and co-edited a text book on technological advances in freeze-drying that was published in January 2019.

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Edmond Ekenlebie

Scientist at Biopharma

Edmond is a principal Scientist at Biopharma. He joined BTL in 2014 after a PhD from Aston University in Birmingham, UK. His PhD focused on the optimisation of the bulk freeze drying process and the implications of powder rheology using methods including the novel use of Micro X-ray tomography. He also holds an MSc in Pharmaceutical Science with Management Studies (Distinction) from Kingston University in London. A Pharmacist since 2006, Edmond previously held managerial roles as both Locum and Superintendent Pharmacist. Dr Ekenlebie currently offers his expertise in consultancy to BTL’s worldwide clientele base and remains heavily involved in research work. His current research collaboration is focused on recombinant vaccine formulation development to break the cold chain. He is extremely passionate about freeze drying and maintains an interest in intellectual property across the freeze drying patent landscape


Karen A. Bossert

Independent consultant, Instructor at Parenteral Drug Association

Karen A. Bossert is an independent consultant specializing in pharmaceutical manufacturing and compliance, focused on sterile products and lyophilization.

She has over 30 years’ experience in pharmaceutical development and manufacturing that includes lyophilization and validation. She received her Bachelor of Science degree in Pharmacy at the Albany College of Pharmacy and her Doctorate in Pharmaceutics at the Philadelphia College of Pharmacy and Science. Prior positions at pharmaceutical and biopharmaceutical firms have included assignments in R&D, commercial operations and Quality Assurance. Her experience in the pharmaceutical industry includes formulation and product development, validation, clinical and commercial production as well as contract manufacture.

Karen has authored and presented numerous papers and courses in freeze drying. She is currently an instructor for the Parenteral Drug Association in the area of validation of lyophilization, and is an active member of several industry associations.