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Australasian Biotechnology (backfiles)
AusBiotech
ISSN: 1036-7128
Vol. 6, Num. 5, 1996
Australasian Biotechnology,
Volume 6 Number 5, September/October 1996, pp.272- 276

A Master's Program in Biopharmaceutical Science

by I.R. Neering*, S.M. Mahler+ and M.W. Fryer*

* School of Physiology and Pharmacology, University of NSW, Sydney 2053
+ Department of Biotechnology, University of NSW, Sydney 2053


Code Number: AU96010
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    Text: 18.6K
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Introduction

The quality of Australia's tertiary education system, like that of its medical research, is widely recognised. However, the majority of the science courses available are generic, giving students a broad basic education rather than a career-oriented training. As career options become more specialised the need to build on that fundamental background has become evident, and in response to this need the CRC for Biopharmaceutical Research has developed a Masters program in Biopharmaceutical Science directly aimed at the focussed training of staff for the biopharmaceutical industry.

The Cooperative Research Centre for Biopharmaceutical Research is uniquely equipped to develop such a course. It is a joint venture of the Garvan Institute of Medical Research, the University of NSW (Department of Biotechnology and the School of Physiology and Pharmacology), the Biomolecular Research Institute (BRI), St Vincent's Hospital, CSL Ltd. and Peptide Technology Limited. Thus it combines academic expertise in molecular and cell biology, production and scale-up, and physiology and pharmacology - all areas crucial to the identification, design and development of biopharmaceuticals - with the commercial approach of two companies with a biopharmaceutical focus. Whilst the primary aim of the Centre is to provide a coordinated research base for the development of an Australian biopharmaceutical industry, it also has an educational commitment aimed at reinforcing Australia's ability to play an active role in the international marketplace for these products. If Australia is to realise its potential as a significant producer of biotechnology-sourced pharmaceuticals into the next millennium, it needs to develop the scientific infrastructure in terms of human resources to underpin the research, development and marketing of these products.

Background

Traditionally most of the development of pharmaceuticals used in Australia is carried out overseas, with the presence of the large pharmaceutical companies being limited to their marketing and regulatory arms. Increasingly, however, new potentially valuable therapeutic compounds are now being developed and manufactured within Australia by Australian companies. The major companies involved in the Australian biopharmaceutical industry include CSL, Fauldings, Biotechnology Australia, AMRAD, Peptide Technology Ltd., Biota Holdings and Cortecs International. At the same time the industry is becoming increasingly internationalised with some of the large multinational organisations becoming major share holders in companies which originated in Australia. Coupled with this, the forming of strategic alliances through joint ventures and technology licensing agreements is evidence that the Australian biotechnology industry is adopting a more international business focus, identifying and exploring niche areas in a competitive world market. The ability to form such strategic alliances means that by subcontracting out aspects of product development, quite small groups of individuals can exploit a potentially new and innovative therapeutic compound through the creation of virtual drug development corporations (Lightfoot, 1996).

Traditionally, the pharmaceutical companies have recruited staff with either a pharmacy degree or a basic science degree with physiology, pharmacology, microbiology or biochemistry major. The larger biopharmaceutical companies such as those mentioned above also employ graduates with degrees in biotechnology, biochemistry or bio-process engineering. Staff with this kind of background are then trained by their organisation to perform regulatory affairs, product specification and development of formulations involving conventional pharmaceuticals.

As the potential of biotechnologically engineered pharmaceuticals becomes more fully realised the need for graduates with knowledge encompassing both conventional pharmacology and biotechnology as well as regulatory affairs and business issues will become paramount. No single program offered instruction in all of these disciplines.

With this in mind, in 1994 the CRC for Biopharmaceutical Research, in conjunction with the University of NSW, established an on-campus Master of Applied Science Degree in Biopharmaceuticals in response to the perceived current and future need for specialist instruction in biopharmaceutical development in Australia. The course is offered by the Faculty of Applied Science and administered through the Department of Biotechnology, and the School of Physiology and Pharmacology at UNSW. The MAppSc (Biopharmaceuticals) incorporates course work at the University and a supervised research project relevant to the pharmaceutical/biopharmaceutical industry, undertaken by students under the auspices of the partners of the Centre. The course covers a broad spectrum of disciplines, including biochemistry, biotechnology, physiology and pharmacology, and ranges from principles to advanced studies in each discipline. Our first group of graduates from the program have all found employment within the pharmaceutical industry.

The on campus course proved so successful that requests for enrolment for the 1996 academic year exceeded the number of DEET funded places available. Clearly, there was a demand for this type of program. Accordingly, In 1996 the Centre established an open learning program in biopharmaceuticals for external students based on the internal MAppSc (Biopharmaceuticals). This is now being offered within Australia, and the CRC is working towards its use for distance education overseas. There have been strong expressions of interest from the UK, Malaysia, Hong Kong, which are the initial target countries for marketing the course.

The Course

Admission to the program

The course is open to graduates with a four year degree in biotechnology, pharmacology or a related discipline. Biochemistry is a prerequisite for entry. For those with only a three year degree, usually a BSc, applications are considered from those who have acquired equivalent qualifications or industry experience. Experience to date with our on-campus students has indicated that more students have a background in molecular biology or microbiology than in pharmacology. A high proportion of students have little background in any of these areas though quite a number of on-campus students and all of our distance students already work in the pharmaceutical industry.

Course work

With the financial assistance of a grant from the New South Wales Government eight learning modules have been developed, based on the same material taught in our on-campus Master s program. Each module consists of subject text, printed readings (reprints of relevant original articles) and self test questions and may also contain audiovisual material in the form of audio and video tapes. The eight unit learning resource modules are constituted as follows:

Basic principles of drug action

This module covers general principles of pharmacodynamics and pharmacokinetics. Pharmacodynamics considers drug-receptor interactions, the basis of dose response curves, reversible and irreversible antagonists, partial agonists and related topics. Events following the drug receptor interaction which include stimulation of second messenger systems and the pharmacology of ion channels are described. The principles governing pharmacokinetics and their clinical importance are discussed in some detail.

Selected topics in pharmacology

For this module the topics were chosen to enable students to gain knowledge of the diversity of receptors in the human body with which drugs commonly interact to produce their main clinical effects or their side effects/toxicological actions. The module begins with an introduction to the autonomic nervous system then works through autonomic receptors, receptors for histamine and serotonin, then to the newer areas of peptide receptors and cytokines, the latter areas being those for which drugs are now being developed. With this background plus some reading material on drugs affecting the central nervous system, it is felt that students will be able to read and understand the pharmacology of most drugs in clinical use.

Techniques for drug development

This module extends the concepts introduced in the basic pharmacokinetics section. More advanced pharmacokinetic problems, such as compartmentation, kinetics of effects and problem solving are included. A detailed section deals with receptor binding and includes a video which describes the practical and theoretical aspects of this technique. The determination of molecular structure and quantitation of drugs in the body are vital aspects of drug development. Accordingly, included in this module, is a section on techniques used in the assay of pharmaceutical compounds. This section deals with some of the latest assay techniques including MALDI mass spectrometry.

Discovery and development of new medicines

This module gives an overview of most aspects of the development of new drugs. Examples of drugs derived from both natural products (plants) as well as those developed using synthetic programs are discussed. Screening of compounds for activity and the issues of toxicological testing are also examined. All phases of clinical trials are dealt with and the viewpoints of both pharmaceutical company and clinical investigator put forward. Regulatory issues and ethical problems are also considered.

Production of recombinant products

In this module, some basic recombinant DNA techniques and heterologous protein expression are examined in prokaryotes and eukaryotes. For prokaryotes, Escherichia coli is the model species chosen and for eukaryotes, the yeast and mammalian cell systems are described. The advantages and disadvantages of the various expression cell systems are outlined. The vectors used for cloning of the protein genes are also described and illustrated. Cloning of genes into the vectors, production and subsequent characterisation of the recombinant protein are also described. The examples are actual biopharmaceutical products currently produced by the biotechnology industry and students are referred to published journal papers throughout the modules.

Principles of fermentation and downstream processing

The units in this module were chosen to give students a good understanding of the fundamental principles associated with biopharmaceutical manufacture and put regulatory principles into the context of biopharmaceutical manufacture. Basic fermentation principles for the large scale culture of bacterial and mammalian cells to produce recombinant protein biopharmaceuticals are discussed. This is followed by a thorough study of the main unit operations associated with product recovery, commonly referred to as downstream processes. The principles of Good Manufacturing Practice, relevant to all aspects of drug manufacture including fermentation and product recovery operations are discussed. Also discussed are modern methods of product characterisation which form a critical component of the regulatory procedure.

Monoclonal Antibody Technology

The first unit of this module serves as an introduction to immunology, emphasising the areas of immunology relevant to antibody production. In addition, the structure of antibody molecules is studied in detail. The second unit discusses the processes in the production of hybridomas, the specialised cells which produce monoclonal antibodies. This unit includes information on immunisation protocols, methods of cell fusion and selection and the production of human monoclonal antibodies by EBV-transformed B cells. Unit 3 is associated with the more recent developments in antibody engineering techniques. The phage display system and genetic manipulations for the production of humanised antibodies and antibody fragments are described in detail. Unit 4 covers the applications of monoclonal antibodies both for in vivo diagnostics and for therapy. Also, some of the more recent innovations such as the production of recombinant immunotoxins are described.

Regulatory considerations, patent issues and licensing

The Code of Good Manufacturing Practice as it applies to the production of recombinant biopharmaceuticals and the establishment of Standard Operating procedures (SOPs) for a production process are examined in this module. There is also an overview of the current state of evolution of the biotechnology industry. The concept of licensing as a viable approach to biopharmaceutical development is discussed as are details of the licensing process itself. The module also introduces the student to the concept of intellectual property as it relates to biopharmaceuticals and provides some guidelines on its management. The creation and protection of intellectual property is the basis on which the development and commercialisation of biopharmaceuticals is built and as such is of vital concern to the industry. The module also provides a detailed consideration of patents and trade secrets as well as touching on trade mark registrations, industrial design registrations and copyright.

During the academic session, distance students participate in a number of tutorials conducted as a teleconference with the author(s) of their printed lecture notes. The tutorials are structured and questions for discussion are distributed to students well in advance of the tutorial session. In addition students have access via the telephone, e-mail or fax to the lecturers. Students are also required to submit written assignments based on the lecture material or on additional reading that has been requested. The assignments and performance at tutorials constitute a form of continuous assessment and are worth 50% of the overall grade for each of the eight modules.

Project

As mentioned above for the on campus program, completion of a supervised project is also a requirement for the distance program. This departs from the present trend in Master's programs which, increasingly, are by course work only. While the administrative load and time demands on academic staff associated with research projects are greater than in simple course-work programs, it was felt that training in independent research methodology is vital if individuals are to pursue effective careers in industry.

Project topics can be drawn from any relevant area: regulatory affairs, licensing and patenting or a laboratory bench project involving any of the core scientific subjects studied in the program. The aim here is not only to complete an independent piece of work but to train students in library research, data presentation and all of the associated skills of industry related research activities.

Projects are sourced from industry, the CRC and from the University of NSW. For those projects carried out in an industry setting, an adviser from the relevant industry is appointed. An academic supervisor from the CRC or University is also appointed. The student thus has two individuals who can provide support and advice during the course of the project and who can offer different perspectives on the work being undertaken. These two individuals also serve as examiners on completion of the project. Occasionally, security issues may arise, as for example when one of our students was involved in a project examining patenting issues on a viral protein. In this case, the academic supervisor was required to sign a non-disclosure agreement.

It may not always be possible for students to do an industry or laboratory based project because of limited access to these facilities perhaps as a result of the remote location of the student. Under this circumstance a literature based project with a University or CRC based supervisor would satisfy the research requirement. As our distance program develops, we are establishing links with other CRCs and with appropriate departments in other universities both in Australia and overseas. These universities will act as nodes for course delivery and provide the infrastructure, both academic and laboratory based, to effectively expand our geographical range of project supervision.

The Future

As the course develops we are looking to improve the dissemination of our material. An increasing use of the Internet is characterising our distance program especially through the use of e-mail for student notification, assignment submission and off-line tutorials. In the future we expect to set up a usenet group for conferencing and are looking into the effectiveness of putting the course material itself onto the Internet. We have a home page which details information for those interested in the course, at the address: http://pathology.med.unsw.edu.:80/Physiology/teaching/external /biopharm/.

As we establish links with other universities and CRCs we expect, by drawing upon their expertise, to increase the breadth of our course by the addition of further modules; vaccine development, growth factors, gene therapy and formulation have already been identified as potential additional modules and their development with experts in the relevant fields is now in progress. This is essential for an area which is changing and developing as rapidly as the biopharmaceutical industry.

References

Lightfoot, G. Drug discovery and VDDCs. Drug Discovery Today, 1: 255-260, 1996.

Copyright 1996 Australian Biotechnology Association Ltd.

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