Biopharmaceutical Production Technology (235.C0)

Students are required to successfully complete four (4) English courses to obtain their DEC. Courses 603-102 and 603-103 may be taken in either order only after successfully completing 603-101. Course 603-200-MQ is the 4th and last English course required. Click to view courses list.

Students are required to successfully complete three (3) Physical Education courses to complete their DEC. Courses 109-101-MQ and 109-102-MQ may be taken in either order, but both must be successfully completed before registering in 109-103-MQ. Click here to view courses list.

Complementary courses provide an opportunity for students to explore subjects outside their field of concentration and are offered in six different areas. Except for Liberal Arts, Arts & Sciences and Double DEC programs, students must take two (2) complementary courses as part of their General Education requirement.
Students are encouraged to select courses from subjects that are outside their program of study;
Students can take a course from each ensemble of the same domain;
Or
Students can take a course from either ensemble of two different domains;
Or
Students can take a course from the same ensemble of two different domains;
Domain 1, Domain 2, Domain 3 , Domain 4 , Domain 5 and Domain 6

Click here to view courses list. 

This basic chemistry course will introduce the student to chemical concepts applicable to the work of a technologist. Topics covered include atomic structure, states of matter, solubility, ionic and non-ionic compounds, acids, bases and buffers. Practical application of purification techniques and use of basic instruments such as spectrophotometers and chromatography will prepare the student for the manufacturing courses.

Computerized and automated systems are used throughout the biopharmaceutical industry; their use is highly regulated and integral to GMP. Students will learn to configure of workstations, use word processing and spreadsheet software, and conduct efficient internet searches to find information relevant to the profession. An additional focus will be placed on network infrastructure; automation and control system concepts will be introduced.

This course will allow the student to explore the scope of the biopharmaceutical industry internationally and in Canada. The role of the technologist in production, quality control and clean utilities operation and maintenance will be explored. Site visits to local biopharmaceutical companies will provide first-hand experience of the biopharmaceutical environment and the functions of a technologist. Various dosage forms and their key manufacturing steps will be presented.

This course introduces the regulatory structure governing the production and marketing of drug products in Canada, the US and Europe. The reasons for the development of regulatory oversight and consequences of non-compliance will be explored using case studies. Specific GMP requirements for the Canadian market will be studied and applied in the manufacturing laboratory courses. The ethical responsibilities of all workers in a GMP environment will be discussed using case studies.

Using pilot-scale equipment, documentation and work practices typical for the industry, students working in teams will manufacture batches of solutions, suspensions, dispersions and emulsions. In-process sampling and finished product assay will be used to evaluate the bulk products. Actual or potential production problems will be examined and solutions developed by the production team. The concepts of critical quality attributes and critical process parameters will be introduced and applied to the production process.

After successfully completing their 603-101 course, students may choose to take either a 603-102 or a 603-103 course. Click here to view courses list. 

Every student needs one of each of the Block “A” and Block “B” courses in order to complete their DEC. For each block, there are four levels of courses: Level 1 , Level 2 , Level 3 and Level 4.
Placement in the appropriate level of French is determined by the students’ high school marks. The French Department reserves the right to change the placement of a student upon written notice. Students take the Block “B” course at the same level as the Block “A” course.
If placement determines that students do not have a college level of proficiency in French, students may be required to take remedial courses to upgrade their knowledge of the language. Click here to view courses list. 

Students need three (3) Humanities courses to complete their DEC. Courses 345-101-MQ and 345-102-MQ may be taken in either order, but both must be successfully completed before registering in 345-21_-AB. Click here to view courses list. 

Collection, analysis and presentation of data are some of the means used to determine product quality and resolve production issues. This course will present the fundamentals of statistics, graphical tools for analysis and presentation of process and experimental data, and determination of confidence intervals. An introduction to probability will lead into the use of statistical sampling plans and determination of acceptable quality levels of materials and products.

This course will introduce the safe work practices, procedures (lock-out/tag-out, confined entry) and personal protective equipment used in the biopharmaceutical industry. Students will learn how to identify hazards and reduce their impact. The importance of MSDS and CSST regulations will be emphasized. Concepts of acute and chronic toxicity as related to hormones, sensitizing agents, opiates, and chemotherapeutic drugs will be introduced. Containment strategies for these materials will be detailed.

Plant design is intended to optimize throughput while respecting GMP. Students will analyze a set of unit operations for liquid and oral solid dosage manufacturing and will explore the relationship between productivity, regulations and facility design. The importance of materials handling and accountability in a regulated environment will be emphasized. Gathering and analyzing performance data will be practiced in lab situations. Student teams will develop recommendations for production optimization using examples from high volume products. Requirements for the use and storage of controlled substances in pharmaceutical production will be presented.

This course will apply the topics studied in GMP I to sterile manufacturing, medical devices, natural health products, and dietary supplements. The regulations for cosmetics and food will be compared to the biopharmaceutical requirements. The application of GMP in special situations such as radiopharmaceuticals, blood banks, veterinary medicines will be presented. Students will evaluate International harmonization efforts and their effect on Canadian biopharmaceutical manufacturers.

In this course students will apply their knowledge of liquid manufacturing to the manufacture of creams, ointments and gels using pilot-scale equipment. Production teams will assay the products and evaluate process improvements. Equipment cleaning methods to reduce product carry-over will be put into practice.

After successfully completing their 603-101 course, students may choose to take either a 603-102 or a 603-103 course. Click here to view courses list. 

Students are required to successfully complete three (3) Physical Education courses to complete their DEC. Courses 109-101-MQ and 109-102-MQ may be taken in either order, but both must be successfully completed before registering in 109-103-MQ. Click here to view courses list. 

This course will introduce the fundamental physical concepts the technologist will encounter in the biopharmaceutical industry. The principles of mechanics, phase change, viscosity, heat and mass transfer will be related to manufacturing processes. Study of electricity & magnetism will prepare the student for troubleshooting of equipment and systems. The practical applications of the principles studied are emphasized.

This course will introduce the student to the role of Quality Control in biopharmaceutical quality management systems. Sampling schemes for raw materials, packaging components, in-process, finished products will be presented. Environmental monitoring for particulates will be practiced. The use of sampling techniques which protect the product and which produce reliable results will be practiced. Statistical sampling plans will be used and the differences between critical, major and minor defects evaluated for different dosage forms and packaging materials.

Production planning optimizes the links between market orders, component lead time and plant capacity. Concepts such as Kanban, 5S, Just In Time will be introduced. The student will learn how to predict resource loading, the constraints of product change-over and cleaning, and the advantages of campaign vs. batch processing. The effective use of Quality Control resources to reduce turnaround time will be discussed. Risk management concepts and the use of planning tools such as Microsoft Project will be covered.

Using pilot scale equipment such as V-blenders, granulators and compression machines, students will manufacture batches of coated and uncoated tablets. In-process controls and the use of statistical process control techniques will allow the student to evaluate the effect of machine settings on product characteristics such as friability and dissolution time.

The packaging of dosage forms has an effect on shelf life, ease of use and market acceptance. In this course students will package tablets in blisters and label cartons following industry practices and equipment such as thermoformers. The concepts of reconciliation and line clearance will be applied. Using clinical scale equipment students will set-up packaging lines and study the effect of processing variables on package quality.

After successfully completing their 603-102 and 603-103 courses, students must choose a 603-200 course. Click here to view courses list.

Students are required to successfully complete three (3) Physical Education courses to complete their DEC. Courses 109-101-MQ and 109-102-MQ may be taken in either order, but both must be successfully completed before registering in 109-103-MQ. Click here to view courses list. 

Students need three (3) Humanities courses to complete their DEC. Courses 345-101-MQ and 345-102-MQ may be taken in either order, but both must be successfully completed before registering in 345-21_-AB. Click here to view courses list. 

In this course students will learn about types of microorganisms, their life cycle, pathogens, endotoxins and their effect on biopharmaceutical production. Using standard microbiologic techniques students will explore the distribution of microbes through the collection of samples from the environment and the manufacturing labs and growing out the colonies.

This course continues the topics of OSD 1 and introduces unit operations such as blending and milling to obtain specific powder properties. Powders will be characterized by tap density and particle size distribution then directly compressed or filled into capsules. In process and finished product testing will be performed. Wet and dry granulation will be used and compared for various active ingredients.

This course will expose the student to the use and configuration of vision systems and bar code readers on a packaging line. Industry bar code standards will be compared and their use in product protection and anti-counterfeiting technologies discussed. The use of RFID tags and “invisible” inks to secure packaging will be presented. Sterile products are a special class of packaged item, the package requirements for maintenance of sterility during the product life and safe use in clinical settings will be introduced.

In this course students will practice sterile and bioburden controlled manufacturing techniques. The typical sterile dosage forms and unit operations leading from raw material to finished product will be discussed. Students will practice gowning, use of sterile techniques and participate in process simulations. GMP for sterile products will be studied and put into practice. The use of terminal sterilization methods and aseptic processing will be analyzed and the effect of facility design and production processes examined.

In this course students will learn quality assurance concepts starting with ISO 9000 and its links to GMP. The role of the biopharmaceutical quality unit and regulatory expectations will be explored using case studies. Techniques for writing effective Standard Operating Procedures, change management systems, and supplier qualification will be introduced.

Students need three (3) Humanities courses to complete their DEC. Courses 345-101-MQ and 345-102-MQ may be taken in either order, but both must be successfully completed before registering in 345-21_-AB. Click here to view courses list. 

Every student needs one of each of the Block “A” and Block “B” courses in order to complete their DEC. For each block, there are four levels of courses: Level 1 , Level 2 , Level 3 and Level 4.
Placement in the appropriate level of French is determined by the students’ high school marks. The French Department reserves the right to change the placement of a student upon written notice. Students take the Block “B” course at the same level as the Block “A” course.
If placement determines that students do not have a college level of proficiency in French, students may be required to take remedial courses to upgrade their knowledge of the language. Click here to view courses list. 

Complementary courses provide an opportunity for students to explore subjects outside their field of concentration and are offered in six different areas. Except for Liberal Arts, Arts & Sciences and Double DEC programs, students must take two (2) complementary courses as part of their General Education requirement.
Students are encouraged to select courses from subjects that are outside their program of study;
Students can take a course from each ensemble of the same domain;
Or
Students can take a course from either ensemble of two different domains;
Or
Students can take a course from the same ensemble of two different domains;
Domain 1, Domain 2, Domain 3 , Domain 4 , Domain 5 and Domain 6

Click here to view courses list. 

Building on the sterile manufacturing concepts, this course will introduce the student to cell-based manufacturing of vaccines, and proteins via fermentation and cell culture. Laboratory work will provide the opportunity to operate a bioreactor, isolate and purify a product. Topics covered include types of fermentation, media and buffers, ultrafiltration, purification techniques such as chromatography, ultrafiltration, and centrifugation. The application of Design of Experiment techniques will be studied.

This course will present the differences and similarities between commissioning and qualification and describe enhanced commissioning approaches. Using production equipment students will carry out risk assessments and determine how to effectively integrate engineering activities with Quality Assurance requirements. Test scripts will be prepared and executed using good documentation practices. The relation between validated and operational ranges will be discussed. Deviation and change management procedures will be explained.

This course will allow the student to conduct aseptic operations in aseptic workstations and introduce typical restricted access barrier systems and isolators. Various formulations such as pre-filled syringes and sterile ophthalmic preparations will be discussed. The effects of particle size and particle density will be studied along with visual inspection techniques. The importance of ingredient compatibility and order of addition will be emphasized. Students will learn sterile gowning techniques, and participate in process simulation (media fills), and microbial monitoring.

This course will introduce the student to methods of developing a quality culture and the use of right first time approaches. The role of internal and regulatory audits will be presented and mock audits carried out. The role of compliance, quality by design concepts and current trends in QA will be studied.

In this course the student will learn the basics of control strategies, the use of PID loops, the importance of good functional specifications and configuration management during the life of an automated system. Good Automated Manufacturing Practices (GAMP) will be explained and the principles demonstrated through case studies. The advantages and constraints on the use of process analytical technologies will be discussed.

The aim of this course is to provide the student with a comprehensive understanding of all aspects of manufacturing biopharmaceutical products. To provide an insight to the science of manufacturing and the current improvement methodology that is used to improve operations, as well as to introduce students to the principles of Management, with a particular emphasis on the behaviour of individuals in organizations. Student will be able to understand and apply principles and practices of manufacturing biopharmaceuticals and also summarise and analyse the issues involved in managing people in an organizational environment. In-class manufacturing exercises will be performed using spreadsheets and company models to provide a biopharmaceutical manufacturing simulation.

Design and operation of HVAC systems, building automation systems, high purity water production and distribution, clean steam systems, clean in place and sterilize in place systems will be studied. The student will participate in production equipment set-up, maintenance and troubleshooting. Preventive and predictive maintenance concepts will be discussed.

Continuous improvement is crucial for biopharmaceutical industries since it improves their profitability. During this course students will learn how to base their work on optimized and clearly communicated and documented processes. This will be achieved by the understanding of what the process is trying to accomplish, then mapping the process with the goal of identifying areas of improvement and eliminating inefficiencies. Finally, they will be able to define recommendations and action plans which will include future state process flows, key performance indicators (KPIs) and cost benefit analysis.

Building on the concepts studied in Validation 1, this course will focus on process validation, cleaning validation and the validation of sterilization techniques. Students will learn how to design effective test plans and evaluate the results.

During a period of five to six weeks, students will act as interns within a biopharmaceutical manufacturing facility. The student will have the opportunity to put into practice the knowledge acquired during this technology program and develop industry contacts for future career opportunities.