BPH633 - Biopharmaceuticals

Subject Title
Biopharmaceuticals

Subject Description
Biopharmaceuticals represents an odyssey of history and discovery of natural and chemically modified products that are commonly employed for pharmacological interventions for a spectrum of diseases and maladies that afflict the human condition and our natural world. The subject covers both biotechnology and natural products and their applications in the area of biopharmaceutical discovery, precision medicine, and lead compound development. Topics will include the basic principles of biotechnology, including the history of modern pharmaceuticals, encompassing ethnopharmacology and ethnomedicinal procedures. Strategies for creating and improving biopharmaceuticals by combinatorial chemistry and rational drug design will be presented. Modern techniques for recombinant protein expression, purification and large-scale biopharmaceutical process development, which encompass the future of biopharmaceuticals and biologics. These include transgenic organisms, genome modification and molecular biological approaches to novel biopharmaceutical drug design. Biopharmaceuticals are increasingly becoming central to human disease treatment and prevention, and are commonly used in the agricultural and animal husbandry fields. Collectively, students in this course will be able to utilize and build upon knowledge and principles obtained in prior courses.

 

Credit Status
BTA, CLP

Learning Outcomes
Upon successful completion of this subject the student will be able to:

1. Explain the basic techniques of biotechnology as they pertain to biopharmaceuticals.
2. Interpret how biotechnology is applied to the production of modern biopharmaceuticals.
3. Discuss how biopharmaceuticals are produced commercially and illustrate the preferred principles of the biopharmaceutical production process.
4. Appreciate how biopharmaceuticals progressively evolve and become refined to minimize off- target effects to evolve precision medicine.
5. Integrate the methodologies associated with high throughput screening and selective side chain modification to improve and modify natural products.
6. Combine biopharmaceutical principles to identify potential novel sources of drug lead targets and their isolation, purification and modification.
7. Apply knowledge to improve lead targets for successful biopharmaceutical commercialization.

Essential Employability Skills

    •  Communicate clearly, concisely and correctly in the written, spoken and visual form that fulfils the purpose and meets the needs of the audience.

    •  Respond to written, spoken, or visual messages in a manner that ensures effective communication.

    •  Apply a systematic approach to solve problems.

    •  Use a variety of thinking skills to anticipate and solve problems.

    •  Locate, select, organize, and document information using appropriate technology and information systems.

    •  Interact with others in groups or teams in ways that contribute to effective working relationships and the achievement of goals.

    •  Manage the use of time and other resources to complete projects.

    •  Take responsibility for one's own actions, decisions, and consequences.

Academic Integrity
Seneca upholds a learning community that values academic integrity, honesty, fairness, trust, respect, responsibility and courage. These values enhance Seneca's commitment to deliver high-quality education and teaching excellence, while supporting a positive learning environment. Ensure that you are aware of Seneca's Academic Integrity Policy which can be found at: http://www.senecapolytechnic.ca/about/policies/academic-integrity-policy.html Review section 2 of the policy for details regarding approaches to supporting integrity. Section 2.3 and Appendix B of the policy describe various sanctions that can be applied, if there is suspected academic misconduct (e.g., contract cheating, cheating, falsification, impersonation or plagiarism).

Please visit the Academic Integrity website http://open2.senecac.on.ca/sites/academic-integrity/for-students to understand and learn more about how to prepare and submit work so that it supports academic integrity, and to avoid academic misconduct.

Discrimination/Harassment
All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecapolytechnic.ca.

Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Accessibility Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.

Camera Use and Recordings - Synchronous (Live) Classes
Synchronous (live) classes may be delivered in person, in a Flexible Learning space, or online through a Seneca web conferencing platform such as MS Teams or Zoom. Flexible Learning spaces are equipped with cameras, microphones, monitors and speakers that capture and stream instructor and student interactions, providing an in-person experience for students choosing to study online.

Students joining a live class online may be required to have a working camera in order to participate, or for certain activities (e.g. group work, assessments), and high-speed broadband access (e.g. Cable, DSL) is highly recommended. In the event students encounter circumstances that impact their ability to join the platform with their camera on, they should reach out to the professor to discuss. Live classes may be recorded and made available to students to support access to course content and promote student learning and success.

By attending live classes, students are consenting to the collection and use of their personal information for the purposes of administering the class and associated coursework. To learn more about Seneca's privacy practices, visit Privacy Notice.

Lecture Notes

1. Even though the topics are listed separately, there will be considerable intermingling of various topics depending on the nature of the subject. For example, we will investigate the developmental progression of particular drugs and biopharmaceuticals to illustrate how a biopharmaceutical is developed for commercial use. During these discussions, we will apply the steps in drug development as well as the relevant technologies, and critically examine the processes and relevant regulations. Moreover, we will examine the impact of new technologies and their use in pharmaceutics, for example aptamers and phage display, in the development of genetically modified organisms (GMO) and for use as therapeutic agents.
2. Class discussion is absolutely required, so if a particular discussion is particularly interesting, we may alter the curriculum to further investigate a different path.
3. Student presentations will take place after Study Week. The presentations are expected to be professional in nature (as though you were giving the presentation to colleagues at work) including positive and negative criticism. Your professor may then continue the discussion as a lecture to further explore the topic. The number of course hours dedicated to student presentations will be determined by the number of students in class.

 
In the end, you as the student, will be expected to be knowledgeable and conversant in the technology, regulations, and the ethics involved in the topics presented by the professor and by your fellow students.
 

Topic #	Upon successful completion of this topic, the student will demonstrate an understanding of the following topics:
1.The drug discovery process and identification of lead compound biopharmaceuticals (6 hours)	Introduction to biopharmaceuticals and lead compound discovery. Diverse biopharmaceuticals derived from plants, fungi, bacteria and animal sources. The role of bioassay guided identification and purification of lead compounds.
2. Small Molecule Building Blocks & Rational Drug Design (4 hours)	Modification of lead biopharmaceutical compounds by selective optimization of side activities and side chain (SOSA) modification. Rational drug design – approaches and examples of in silico aided drug discovery and optimization, fostering precision medicine.
3. Combinatorial Chemistry Methods & Strategies (4 hours)	The use of combinatorial chemicals, methods and procedures for the creation of biopharmaceutical drug libraries will be investigated with the aim of identifying novel drug targets. Biochemical approaches highlighting the use of phage display libraries and aptamer technology will be illustrated with specific examples of each.
4. High Throughput Screening (4 hours)	Concepts and ideas for designing and utilizing high throughput methodologies for screening large libraries of biopharmaceutical drugs for hit compounds will be presented, including microarray, in vitro, model organismal and “organ-on-a-chip” screens will be assessed. A review of colorimetric, fluorescent and chemiluminescent techniques will be presented.
5. Biopharmaceutical Production in Heterologous Hosts – E. coli Systems (3 hours)	Recombinant product production in prokaryotic hosts and methods for optimal expression and purification will be investigated. Vector design and use will be highlighted to illustrate the utility of currently used procedures for heterologous protein production in E. coli and related prokaryotes.
6. Heterologous Hosts - Yeast & Filamentous Fungi (3 hours)	The utility and necessity of lower eukaryotic hosts for protein production will be presented, illustrating the advantages of such hosts for producing pharmaceutical grade products.
7. Recombinant Protein Production in Mammalian Cells ( 3 hours)	The importance of utilizing higher eukaryotic hosts for specific biopharmaceutical will be presented highlighting the advantages of protein production in mammalian systems.
8. Genome Modification for Biopharmaceutical Applications (3 hours)	CRISPR/Cas technology will be introduced with specific emphasis on genome modification of animal genomes for recombinant expression of important biopharmaceutical products.