Base Knowledge
Cellular and Molecular Biology, Immunology, Pharmacology I and II, Pharmacotherapy I and II
Teaching Methodologies
The outlined syllabus focuses on current biotechnological methodologies, spanning from theoretical foundations to the specifics of experimental conditions for obtaining and scaling the production of biotechnological drugs approved for human use, as well as innovative biomaterials with health applications. Moreover, it aims to empower students with cutting-edge knowledge in the biomedical field and tissue regeneration, an emerging area of human health.
Teaching methodologies (TM) will combine pedagogical innovation strategies incorporating moments of active and student-centered learning. The goal is to acquire systemic thinking skills, critical attitudes, and problem-solving abilities related to strategies for obtaining biotechnological drugs, biomaterials, and regenerative medicine, along with their respective applications:
TM1 – Interactive expository teaching using appropriate audiovisual means, with active moments of individual learning focused on solving real biotechnology problems for knowledge application: Mentimeter Platform (Wordcloud, Q&A, Multiple Choice, Ranking tools) [Modules 1-7]
TM2 – Interactive expository teaching using audiovisual means with active group learning moments centered on the analysis and discussion of scientific articles in the field for knowledge application: Jigsaw Activities [Modules 1-7]
TM3 – Interactive expository teaching using audiovisual means with active group learning moments focused on the analysis and discussion of scientific articles in the field for knowledge application: Think-Pair-Share Activities [Modules 1-8]
TM4 – Teaching based on planning and resolution: practical application oriented towards action by solving challenges, allowing the development of competencies in biopharmaceuticals and establishing biosimilarity [Modules 3 and 8]
TM5 – Project-based teaching: practical application oriented towards action by developing a biosimilarity research project following EMA guidelines. The instructor facilitates the learning process through synchronous guidance on the Jamboard Platform [Module 8]
TM6 – Project-based teaching: practical application oriented towards action by presenting the developed group project in a Pitch format, aiming to enhance oral communication skills in biotechnology [Module 8]
Students are encouraged to organize their learning process, valuing their abilities to learn and collaborate. The expository method, crucial for structured knowledge acquisition, is complemented by the analysis of scientific articles in student-centered learning contexts within cognitive, collaborative, and behavioral fields, fostering competency systematization. Furthermore, problem-solving and project construction are dynamic, motivating methodologies that empower students to adopt a critical, reflective, and collaborative approach to the subject matter.
Learning Results
This curriculum unit aims to provide forefront knowledge derived from current scientific and technological advancements in the field of Biotechnological Drugs. By the end, the student is expected to:
C1 – Integrate and apply acquired knowledge in emerging areas of molecular biotechnology and biotechnological processes, particularly focusing on biopharmaceuticals applied to human health
C2 – Understand the main biotechnological drugs, their pharmacological actions, and therapeutic indications
C3 – Plan and propose methodologies for biopharmaceutical production and the design of innovative therapeutic strategies based on a multidisciplinary methodology, combining integrated problem-solving skills
C4 – Understand the protocols and regulations applicable to biossimilarity establishment
C5 – Develop scientific and technological reasoning, along with oral and written communication skills using appropriate scientific terminology, enhancing collaboration skills and critical thinking abilities.
Program
Theoretical (T) and Theoretical-Practical (TP) Framework
Module 1. Molecular Biotechnology and Bioprocess Concepts (2h T)
1.1. Recombinant DNA and hybridoma
1.1.1. Cloning vectors
1.1.2. Hosts
1.1.3. Bioprocesses
1.2. Biotherapeutics versus Conventional Drugs
Module 2. Biopharmaceutical Production (4h T)
2.1. Production of recombinant proteins and monoclonal antibodies
2.2. Prokaryotic/eukaryotic systems for heterologous expression
2.3. Post-translational modifications
2.4. Protein engineering
2.5. Directed mutagenesis
2.6. Combinatorial mutagenesis
Module 3. Classes of Biopharmaceuticals (6h T + 3h TP)
Methods of obtaining, pharmacological actions, and therapeutic indications of the following classes of biotechnological drugs:
3.1. Blood factors
3.2. Hormones
3.3. Growth factors
3.4. Cytokines
3.5. Enzymes
3.6. Monoclonal antibodies
Module 4. Biomaterials, Nanotechnology, and Delivery Systems (6h T)
Methods of obtaining and therapeutic innovation of nanodrugs with AIM (FDA/EMA):
4.1. Nanopharmaceutical formulations based on nanocrystals
4.1.1. Aprepitant, nanocrystalline form
4.1.2. Calicium hydroxyapatite, nanocrystalline paste
4.1.3. Rapamycin, nanocrystalline form
4.1.4. β-tricalcium phosphate, nanocrystalline form
4.1.5. Fenofibrate, nanocrystalline form
4.2. Nanopharmaceutical formulations based on liposomes
4.2.1. Liposomal daunorubicin
4.2.2. Liposomal irinotecan
4.2.3. Liposomal cytarabine
4.2.4. Liposomal vincristine
4.2.5. Liposomal amphotericin B
4.2.6. Encapsulated daunorubicin and cytarabine in liposomes
4.3. Nanopharmaceutical formulations based on polymers
4.3.1. Pegylated certolizumab
4.3.2. Pegylated adenosine deaminase
4.3.3. Pegylated filgrastim
4.3.4. Pegylated L-asparaginase
4.3.5. Pegylated interferon α-2A
4.3.6. Methoxypolyethylene glycol-epoetin β
4.4. Other types of nanopharmaceutical formulations based on polymers and proteins
4.4.1. Glatiramer acetate
4.4.2. Polymeric nanosuspension of leuprolide acetate
4.4.3. Encapsulated estradiol, micellar emulsion
4.4.4. Triamcinolone, PLGA hydrogel
5. Paclitaxel conjugated with albumin NPs
6. Nanoparticles (NPs) and in vivo imaging (smart imaging)
Module 5. Vaccine Production (4h T + 2h TP)
5.1. Attenuated/inactivated vaccines
5.2. Purified proteins/polysaccharides
5.3. Recombinant proteins
5.4. Nucleic acids
Module 6. Gene Therapy (4h T)
6.1. Viral vectors
6.2. Non-viral vectors
6.3. Gene introduction/replacement and gene expression modulation
6.4. Gene repair
6.4.1. Zinc Fingers
6.4.2. Talen
6.4.3. CRISPR/Cas9
Module 7. Cell Therapy and Tissue Engineering (2h T)
7.1. Stem cells (SC): potential, limitations, and applicability
7.1.1. Embryonic/induced pluripotent SC
7.1.2. Multipotent SC
Module 8. Biosimilars (2h T + 10h TP)
8.1. Nomenclature and International Nonproprietary Names (INN)
8.2. Reference product
8.3. Differences between biosimilars and generic drugs
8.4. Stages of biosimilar development
8.4.1. Quality-by-design (QbD)
8.4.2. Quality target product profile (QTPP)
8.5.3. Critical Quality Attributes (CQAs)
8.5. Guidelines for biosimilarity investigation (EMA)
8.5.1. Preclinical comparative studies
8.5.2. Clinical comparative studies
8.5.2.1. Safety
8.5.2.2. Efficacy
8.5.2.3. Pharmacokinetic and pharmacodynamic studies
8.5.2.4. Immunogenicity
8.5.2.5. Risk management
8.6. Post-marketing safety monitoring
8.7. Interchangeability and substitution of biosimilars
8.8. Economic aspects of biosimilars use
Module 9. Industrial Biotechnological Workflow (2h T + 1h TP)
9.1. Upstream processes
9.2. Fermentation and Biotransformation
9.3. Downstream preparation
9.4. Pure product
9.5. Bioinformatics applications
Curricular Unit Teachers
Internship(s)
NAO
Bibliography
Principal Bibliography
– Advances in Pharmaceutical Cell Therapy – Principles of Cell-Based Biopharmaceuticals
https://doi.org/10.1142/9240 | November 2015. By (author): Christine Günther, Andrea Hauser and Ralf Huss ISBN 978-981-4616-78-2
– Crommelin Daan J. A. 340; Pharmaceutical biotechnology. ISBN: 978-1-4200-4437-9
Secondary Bibliography
– Cell Therapy – Current Status and Future Directions. Editors – Dwaine F. Emerich; Gorka Orive. DOI https://doi.org/10.1007/978-3-319-57153-9. Springer International Publishing AG 2017. Humana Press, Cham. ISBN 978-3-319-57152-2
– Biomaterials Science (Fourth Edition) – William R. Wagner, Shelly E. Sakiyama-Elbert, Guigen Zhang, Michael J. Yaszemski, Buddy D. Ratner, Allan S. Hoffman, Frederick J. Schoen, Jack E. Lemons. Academic Press,2020. ISBN 9780128161371. DOI: https://doi.org/10.1016/B978-0-12-816137-1.05001-7.