Biotechnological Drugs

Cellular and Molecular Biology, Immunology, Pharmacology I and II, Pharmacotherapy I and II

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.

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.

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 application

Continuous Assessment
T Matrix (15 pts): An assessment is conducted where it is mandatory to achieve a minimum grade of 9.5 out
of 20 for approval.

TP Matrix (5 pts): Continuous assessment focused on building a biosimilarity establishment project. Approval
in the practical matrix is mandatory, with a minimum grade of 9.5 out of 20. The final grade is obtained
through a weighted average of the assessment components from T and TP Matrices.
2. Written Exam
Regular Period, Supplementary Period, Special Period: Written assessment covering T and TP Matrices.
Minimum score=9.5 out of 20. An oral exam may be used when deemed necessary. Evaluation will be carried
out in accordance with the current academic regulations.

NAO