Production Technology for Vaccines and Adjuvants

Recommended Prerequisites

Immunology, biotechnology; pharmaceutical technology; microbiology; virology.

Teaching Methods

Expositive lectures.

Presentation of investigational scientific articles or reviews made by students.

Movie about the discover of the polio vaccine.

Outros videos| Other small videos: biotechnology industry, techniques of administration of vaccines.

Learning Outcomes

From the point of view of content and critical reflection, the students should:

Understanding the vaccine production process and the extent to which these processes can contribute to the vaccine composition/characteristics. Knowing practical examples.

To acquire knowledge on the tests required for the vaccine analysis: raw materials, intermediate and finished product.

Know and understand the legislation for licensing of new vaccines and adjuvants

Acquire skills to administer vaccines and understand the origin of the adverse reactions that might be associated.

Knowing examples of the development of new vaccines.

Knowing the licensed adjuvants and those under investigation.

Motivate to the area of ​​research into new vaccines and / or new adjuvants.

Students should be able to perform functions in both the area of ​​research and in the production and quality control in vaccine production industry and also to make the administration of vaccines at pharmacies.

Work Placement(s)

No

Syllabus

History of the vaccines

The role of the WHO on vaccine area

Administration of the vaccines (techniques and secondary effects).

Methods of production of vaccines for human and veterinary

Production of antigens using recombinant technology. Virus like particles (VLP’s): Practical examples

Live attenuated and inactivation of antigens. Examples.

Carbohydrate vaccines and conjugated vaccines.

Lyophilization and sterilization in the production of injectable vaccines.

Biosafety on Biotechnology industries.

Quality control: tests described in the Pharmacopoeias.

Stability of vaccines and its relation with logistics and distribution.

Vaccine adjuvants approved and in research phase: composition and possible mechanism of action: aluminum compounds; MF59; ISCOMATRIX, molecules derived from the host with adjuvant function, CpG ODN adjuvant's function, MPL, QS-21, Nano and microparticles.

The regulatory system for vaccines and adjuvants

Research on vaccines.Themes discussed by students.

Head Lecturer(s)

Olga Maria Fernandes Borges Ribeiro

Assessment Methods

Final Assessment
Exam: 100.0%

Continuous Assessment
Other: 5.0%
Synthesis work: 15.0%
Frequency: 80.0%

Bibliography

 -The Vaccine book, edited by Barry R. Bloom, Elsevier Science Academic Press, 2003

-Vaccines; 3^rd ed. ; Plotkin SA,OrensteinWA, editors; Philadelphia, W. B. Saunders Co., 1999

-Immunopotentiators in Modern vaccines, ed. By Virgil E.J.C. Schijns and Derek T. O’Hagan, Elsevier Academic Press 2006

Novel Immune potentiators and delivery technologies for next generation vaccines”, Manmohan Singh, Springer, London 2013

 -Good manufacturing practices for biological products; WHO Technical Report Series, No.822,1992

-Laboratory biosafety manual, 3^rd ed.; WHO 2004

-Recent journal articles chosen by students as a basis of their oral presentations