Pharmaceutical Biotechnology Syllabus 2024-2025 (Hashemite University) PDF

The Hashemite University ‫الجامعـــــــــــــة الهاشمـيــــــــــــــــة‬ Faculty of Pharmaceutical Sciences ‫كلية العلوم الصيدالنية‬ Syllabus: Pharmaceutical Biotechnology (#131702576)...

The Hashemite University ‫الجامعـــــــــــــة الهاشمـيــــــــــــــــة‬ Faculty of Pharmaceutical Sciences ‫كلية العلوم الصيدالنية‬ Syllabus: Pharmaceutical Biotechnology (#131702576) First Semester 2024 /2025 COURSE INFORMATION Course Name: Pharmaceutical Biotechnology Course Code: 131702576 Learning method: Face-to-face learning Section: As per semester Semester: First Core Curriculum: 2019 Department: Department of Pharmaceutics and Pharmaceutical Study Plan Technology JNQF Level: 7 Faculty: Pharmaceutical Sciences Day(s) and Time(s): According to HU courses timetable/semester Credit Hours: 2 (Theory) Classroom: As per semester Prerequisites: 131702458 Date prepared: January 2020 (Immunology and vaccines) Date updated: October 2024 COURSE DESCRIPTION The aim of this course is to recognize the students with the importance of biotechnology in our life, the principles of molecular biology and gene technology including restriction enzyme, selection of genes, insertion into vectors, expression, and purification of proteins. In addition to the techniques used in the separation and identification of proteins such as SDS-PAGE and Western blot. The course will also discuss the different biologicals synthesized by biotechnology including proteins, glycoproteins and monoclonal antibodies. Furthermore, fermentation processes used in the synthesis of antibiotics, vitamins, as well as pharmaceutical excipients are also studied. And lastly, the formulation of the biopharmaceutical, essential excipients added and guidelines of FDA and EMA for approval of biologicals and biosimilars will be discussed. DELIVERY METHODS The course will be delivered through a combination of active learning strategies. These include:  PowerPoint lectures and active classroom-based discussion Students will be encouraged to participate and be actively involved in the learning process. Lectures will start with questions to inquire about the students’ prior knowledge of the topic. These questions will also be repeated at the end of the lecture to gain insight into the students’ competences (to verify whether students have understood the topic). During delivering the lecture, 1 ASAS  time will be given to allow students to reflect about what they have learnt and think in and discuss the topic of the lecture.  Relevant films and documentaries  Video lectures FACULTY INFORMATION Name Dr. Ala AbuHammad Academic Title: Assistant Professor Office Location: Third Floor, Office A-3409 Telephone Number: Extension: 3428 Email Address: [email protected] Office Hours: As announced per semester Please send an e-mail ([email protected]) to meet at any other time. REFERENCES AND LEARNING RESOURCES Required Textbook(s):. Pharmaceutical biotechnology, fundamentals and applications, 2019, edited by Daan J.A. Crommelin, Robert D. Sindelar, Bernd Meibohm, 5th ed, Springer Cham, ISBN-hard copy: 978-3-030-00709-6 DOI: https://doi.org/10.1007/978-3-030-00710-2 Additional useful Textbook(s): Nanobiotechnology: concepts, applications and perspectives (Vol. 1). John Wiley & Sons edited by Christof M. Niemeyer, and Mirkin, C.A. eds., 2004.. Additional Resources: Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications, 2012, Oliver Kayser and Heribert Warzecha, Wiley VGH, ISBN: 978-3-527-32994-6 DOI: https://doi.org/10.1002/9783527632909 Journals: Journal of Pharmaceutical Biotechnology Journal of Biological Chemistry BioTechniques (https://www.biotechniques.com/): A journal and website offering articles, protocols, and news in biotechnology, molecular biology, and related fields. Useful Web Resources: Websites: - Moodle 2 ASAS - FDA Biologics (https://www.fda.gov/vaccines-blood-biologics): Offers resources on the approval process and regulations for biological products and biosimilars in the U.S. European Medicines Agency (EMA) (https://www.ema.europa.eu/): Access to guidelines and regulations regarding biopharmaceuticals, biosimilars, and biotechnology products. Additional Useful Web Resources (Learn with fun!): - NCBI - National Center for Biotechnology Information (https://www.ncbi.nlm.nih.gov/): Provides a wealth of resources including gene databases, protein sequences, and molecular biology tools. - Biotechnology Innovation Organization (BIO) (https://www.bio.org/): Offers insights on the latest developments in biotechnology industries, regulations, and innovations. - KEGG (Kyoto Encyclopedia of Genes and Genomes) (https://www.genome.jp/kegg/): A resource for understanding biological pathways, gene functions, and molecular interactions in biotechnology. - LabXchange by Harvard (https://www.labxchange.org/): An online platform offering interactive learning resources, virtual labs, and molecular biology experiments related to biotechnology and pharmaceutical science. - Biointeractive by HHMI (https://www.biointeractive.org/): Features interactive tools, animations, and videos that explore key concepts in genetics, molecular biology, and biotechnology. Great for visualizing gene technology and protein expression. - Biotech-Careers.org (https://www.biotech-careers.org/): A career-focused platform with interactive resources like job simulations, detailed biotechnology processes, and biotechnology career path exploration. - PhET Interactive Simulations (https://phet.colorado.edu/): Offers interactive simulations related to biology, chemistry, and molecular structures, allowing students to visually explore key concepts in biotechnology. 3 ASAS  COURSE OBJECTIVES After course completion students will be able to: 1. Demonstrate a good awareness of uses of biotechnology. 2. Emphasize the main concepts regarding the methodologies of genetic engineering and their application in the manufacturing of biopharmaceuticals and biomedical research. 3. Understand the manufacturing, pharmacology, formulation, storage conditions and the proper route of administration of commonly used biopharmaceuticals. 4. Gain Knowledge in manufacturing of enzymes, vitamins, biopolymers and antibiotics using fermentation biotechnology. 5. Self-learn how to identify and manage manufacturing-related problems of biopharmaceuticals. COURSE INTENDED LEARNING OUTCOMES (CILOs) A. Foundational Knowledge A.1 Classify drugs whether they are chemicals or biological drugs A.2 Gain basic knowledge in the different methodologies of molecular biology and how to use in the manufacturing of biopharmaceuticals. A.3 Explain how different antibiotics can be synthesized by fermentation and the best strain of microorganism that can be used. A.4 Distinguish the different targets of monoclonal antibodies, the obstacles in their production and the structural modifications made. A.5 Know the pharmacist role in the formulation, handling, and correct storage of the biopharmaceuticals. A.6 Demonstrate knowledge and understanding of newly emerging aspects of pharmaceutical biotechnology such as gene therapy and stem cells. 4 ASAS  A.7 Understand the guidelines developed by the FDA and EMA for the approval of biological drugs and biosimilars. B. Essentials for Practice and Care B.1 Identify troubleshooting in molecular biology techniques during production of biopharmaceuticals. B.2 Collect, compare, analyze, evaluate, and summarize the basic sources of information in the scientific literature related to production and problem solving in pharmaceutical biotechnology. C. Approach to Practice and Care C.1 Design a plan to produce a biopharmaceutical starting from the collection of DNA information to the therapeutic protein. C.2 Recognize manufacturing problem and being able to develop better method to improve yield and decrease cost. D. Personal and Professional Development D.1 Communicate effectively with patients, caregivers, peers, and other healthcare providers about the proper use, side effects, storage, and administration of biopharmaceuticals. D.2 Display positive self-confidence when working with others. D.3 Demonstrate creative solutions of troubleshooting in molecular biology. ACADEMIC SUPPORT It is The Hashemite University policy to provide educational opportunities that ensure fair, appropriate and reasonable accommodation to students who have disabilities that may affect their ability to participate in course activities or meet course requirements. Students with disabilities are encouraged to contact their instructor to ensure that their individual needs are met. The University through its Special Need section will exert all efforts to accommodate for individual’s needs. Special Needs Section: 5 ASAS Tel: 00962-5-3903333 Extension: 4209 Location: Students Affairs Deanship/ Department of Student Welfare Services Email: [email protected] [email protected] COURSE REGULATIONS Participation Class participation and attendance are important elements of every student’s learning experience at The Hashemite University, and the student is expected to attend all classes. A student should not miss more than 15% of the classes during a semester. Those exceeding this limit of 15% will receive a failing grade regardless of their performance. It is a student’s responsibility to monitor the frequency of their own absences. Attendance record begins on the first day of class irrespective of the period allotted to drop/add and late registration. It is a student’s responsibility to sign-in; failure to do so will result in a non-attendance being recorded. In exceptional cases, the student, with the instructor’s prior permission, could be exempted from attending a class provided that the number of such occasions does not exceed the limit allowed by the University. The instructor will determine the acceptability of an absence for being absent. A student who misses more than 25% of classes and has a valid excuse for being absent will be allowed to withdraw from the course. On average, students need to spend 6 hrs of study and preparation weekly. At the beginning of the lectures, students should be on time and should not leave before the end of the lecture without an accepted excuse. If the student missed a class, it is his/her responsibility to find out about any announcements or assignments they have missed. For any clarification, students should communicate with their instructor at the posted office hours or by appointment. Students should listen well to the lecture, if anyone has a question, he/she should ask the instructor. Students can find the course material at the course Microsoft team/Moodle after the lecture. Sharing of course materials is forbidden. No course material including, but not limited to, course outline, lecture hand-outs, videos, exams, and assignments may be shared online or with anyone outside the class. Any suspected unauthorized sharing of materials, will be reported to the university’s Legal Affairs Office. If a student violates this restriction, it could lead to student misconduct procedures. Plagiarism Plagiarism is considered a serious academic offence and can result in your work losing marks or being failed. HU expects its students to adopt and abide by the highest standards of conduct in their interaction with their professors, peers, and the wider University community. As such, a student is expected not to engage in behaviours that compromise his/her own integrity as well as that of The Hashemite University. Plagiarism includes the following examples, and it applies to all student assignments or submitted work: 6 ASAS   Use of the work, ideas, images or words of someone else without his/her permission or reference to them.  Use of someone else's wording, name, phrase, sentence, paragraph or essay without using quotation marks.  Misrepresentation of the sources that were used. The instructor has the right to fail the coursework or deduct marks where plagiarism is detected Missed Assessments In all cases of assessment, students who fails to attend an exam on the scheduled date without prior permission, and/or are unable to provide a medical note, will automatically receive a failure grade for this part of the assessment. In cases where a student misses an assessment on account of a medical reason or with prior permission; in line with university regulations an incomplete grade for the specific assessment will be awarded and an alternative assessment or extension can be arranged. Cheating Cheating, academic disconduct, fabrication and plagiarism will not be tolerated, and the university policy will be applied. Cheating policy: The participation, the commitment of cheating will lead to applying all following penalties together:  Failing the subject, he/she cheated at  Failing the other subjects taken in the same course  Not allowed to register for the next semester  The summer semester is not considered as a semester Student Complaints Policy Students at The Hashemite University have the right to pursue complaints related to faculty, staff, and other students. The nature of the complaints may be either academic or non- academic. For more information about the policy and processes related to this policy, you may refer to the students’ handbook. COURSE ASSESSMENT Course Calendar and Assessment Students will be graded through the following means of assessment: Course Assessment Plan Assessment Grade Deadline CILOs Weighting Assessment A B C D th First Exam 25% ~ 6 week A B C D Second Exam 25% ~ 10th week A B C D Final Exam 50% ~ 15th /16th A B C D week 7 ASAS  Description of Exams Test questions will predominately come from material presented in the lectures and the lectures themselves. Semester exams may be conducted during the regularly scheduled lecture period. Exam may consist of a combination of multiple choice, short answer, match, true and false, and/or descriptive questions. No make-up exams will be given. Only documented absences will be considered as per HU guidelines. Make-up exams may be different from regular exams in content and format. Grades are not negotiable and are awarded according to the following criteria: Letter Grade Description Grade Points A+ Excellent 4.00 A 3.75 A- 3.50 B+ Very Good 3.25 B 3.00 B- 2.75 C+ Good 2.50 C 2.25 C- 2.00 D+ Pass 1.75 D Pass 1.50 F Fail 0.00 I Incomplete - WEEKLY LECTURE SCHEDULE AND CONTENT DISTRIBUTION “Lecture hours and weeks are approximate and may change as needed” Note: For the 2 lecture periods per week (S/T, M/W), one lecture period covers 1 lecture hour (50 minutes). The course content specifies chapters of the textbook that will be included in exams. All lectures are delivered by face-to-face learning. Course Content Week Number No. of Hours CILOs Subject Delivery Methods Assessment Methods 1 2 A Introduction to Active Classroom- - pharmaceutical biotechnology Based Discussions and the course outline 2 2 A, B, C, D Molecular biology PowerPoint Exams - Cell Components; Lectures Carbohydrates, and Lipids, DNA, RNA, Peptides and Active Classroom- 8 ASAS  Nucleic Acids: DNA and Based Discussions RNA, - Chromosomes, Genes, and Relevant Videos Genomes 3-4 4 A, B, C, D Molecular biology PowerPoint Exams DNA Replication and Repair Lectures Transcription and Translation - Processes of Active Classroom- transcription and Based Discussions translation in protein synthesis. Relevant Videos - Role of ribosomes and tRNA in drug design. - Gene Expression and Control in Eukaryotes - Regulation of gene expression and its impact on drug production. - Transcriptomics - Epigenetics and gene expression in disease treatment. 5 2 A, B, C, D Molecular biology PowerPoint Exams Recombinant DNA Technology Lectures and PCR Active Classroom- - Techniques for Based Discussions manipulating genes (Gene Cloning, Relevant Videos Restriction Enzymes, Vectors, Transformation - PCR and its applications in biotechnology. 6 2 A, B, C, D Molecular biology PowerPoint Exams Sequencing and Nucleic Lectures Acid Hybridization Active Classroom- - DNA sequencing Based Discussions technologies. - Applications of Relevant Videos hybridization arrays in drug discovery. - Genomics 9 ASAS  7-8 4 A, B, C, D Fermentation Processes and PowerPoint Exams Biopharmaceutical Lectures Production Active Classroom- - Synthesis of antibiotics, Based Discussions vitamins, and pharmaceutical Relevant Videos excipients. - Applications of fermentation in biotechnology. - Synthesis of primary and secondary metabolites (antibiotics) - Formulation of biopharmaceuticals 9-10 2 A, B, C, D Protein Drugs and PowerPoint Exams Monoclonal Antibodies Lectures - Production of insulin, Active Classroom- growth hormone, and Based Discussions monoclonal antibodies. - Therapeutic Relevant Videos applications in cancer, autoimmune diseases, and allergy. - Proteomics - Cell lines and protein expression 11 2 A, B, C, D Nanobiotechnology in Drug PowerPoint Exams Delivery Systems Lectures - Nanotechnology Active Classroom- applications in Based Discussions developing drug delivery systems. Relevant Videos - Liposomes and nanoparticles in targeting drugs to specific tissues. 12 2 A, B, C, D Basic Immunology and PowerPoint Exams Viruses: Structure and Lectures Function Active Classroom- - Introduction to the Based Discussions immune system and its role in disease Relevant Videos 10 ASAS  prevention. - Viral structure, function, and their applications in vaccines and therapies. 13 2 A, B, C, D Gene Therapy and Stem PowerPoint Exams Cells Lectures - Pharmacogenomics & Active Classroom- Principles and Based Discussions applications of gene therapy in treating Relevant Videos genetic disorders. - Stem cells and their potential in regenerative medicine. 14 2 A, B, C, D Emerging Trends in PowerPoint Exams Biotechnology Lectures - Advances in CRISPR Active Classroom- and gene editing. Based Discussions - Future trends in personalized medicine Relevant Videos and synthetic biology (e.g. role of Omics technologies). 15 - University Final Exams 11 ASAS