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Quick Facts
| Medium Of Instructions | Mode Of Learning | Mode Of Delivery |
|---|---|---|
| English | Self Study | Video and Text Based |
Course Overview
This Making a Cell Therapy: Principles and Practice of Manufacturing training is a nine weeks online course. This course was designed and offered through the Massachusetts Institute of Technology via the EDX platform. Krystyn Van Vliet explains this online course.
Cellular therapies are live products that work only when they are delivered alive. This course will cover the fundamentals of cellular biology, which governs cellular growth and metabolism. Some cell therapies' improved function is dependent on our ability to engineer the cells genetically. This course will teach current and emerging approaches to genetic modification, as well as how we isolate cells from patients or donors and manipulate them, such as assisting those cells in growing and multiplying outside of the body, to generate a living product at a therapeutically relevant dose. This course will teach some of the analytical methods used to accomplish this and why these methods were chosen.
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The Highlights
- Nine weeks online course
- Five to seven hours per week
- Self-paced
- Video transcript
- Shareable completion certificate
- Access to course materials
Programme Offerings
- Graded Assignments and Exams
- Intermediate level
- Massachusetts Institute of Technology designed syllabus
- World-class institutions
- and universities
Courses and Certificate Fees
| Fees Informations | Certificate Availability | Certificate Providing Authority |
|---|---|---|
| INR 15595 | yes | MIT Cambridge |
Making a Cell Therapy: Principles and Practice of Manufacturing certification fees varies for the different kinds of tracks mentioned below chosen by the candidates.
Making a Cell Therapy: Principles and Practice of Manufacturing Certification Fee Structure
Description | Amount in INR |
Verified Track | Rs. 15,595 |
Audit Track | Free |
Eligibility Criteria
Certification Qualifying Details
- The Massachusetts Institute of Technology offers this Making a Cell Therapy: Principles and Practice of Manufacturing certification by the EDX platform. Candidates must attend and successfully complete the course in order to receive the certification.
What you will learn
After completing this Making a Cell Therapy: Principles and Practice of Manufacturing certification syllabus users will be able to understand the concepts of Cell biology and immunology, as well as cell therapy manufacturing practices and analytics, which are all areas of study. Cell therapy industrialization and cell therapy regulatory requirements. This course will teach you about the unique properties of cell therapies and how they influence manufacturing, delivery, and supply chain decisions. Cell therapies are a subset of the larger pharmaceutical industry, which is governed by regulations. This course will teach you how drugs are regulated and how those regulations apply to cellular therapies in particular.
Who it is for
This course is intended to provide learners interested in pursuing a career in this exciting new field with an overview of the key concepts required to manufacture cell therapy.
- Geneticist
- Drug Inspector
- Pharmacist
Admission Details
Students may take the following steps to gain admission to Making a Cell Therapy: Principles and Practice of Manufacturing certification course classes:
Step 1: Follow the official URL: https://www.edx.org/learn/cellular-biology/massachusetts-institute-of-technology-making-a-cell-therapy-principles-and-practice-of-manufacturing
Step 2: Participants must create an account on the Edx website.
Step 3: Only after the participant has registered and logged in is admission confirmed.
The Syllabus
- About This Course
- Entrance Survey
- Unit overview
- Course introduction
- History of cell therapies (4 Questions)
- Overview of cell therapy manufacturing (2 Questions)
- Meet the experts
- Unit overview
- Cell structure (5 Questions)
- Cell cycle (4 Questions)
- Nutrients and conditions for cell division (4 Questions)
- Stem cells and cell signaling (5 Questions)
- Immunology (5 Questions)
- Overview of genetic engineering (3 Questions)
- Plasmids for genetic engineering (4 Questions)
- Gene transfection techniques (3 Questions)
- Viral vectors for genetic engineering (6 Questions)
- Gene editing technologies (3 Questions)
- Types of cell therapies (4 Questions)
- Meet the experts
- Problem Set (17 Questions)
- Unit overview
- The cell therapy manufacturing process
- Acquisition and isolation of cells (4 Questions)
- Activation and genetic modification of cells (5 Questions)
- Expansion of cells (6 Questions)
- Harvest, formulation, and administration of cells (4 Questions)
- Meet the experts
- Unit overview
- Introduction to critical quality attributes (CQAs)
- Experimental tools in cell biology (4 Questions)
- Experimental tools in molecular biology (5 Questions)
- Cell-based functional assays (4 Questions)
- Replication-competent vector assays (3 Questions)
- Microbiological assays (3 Questions)
- Endotoxin and particulate assays (3 Questions)
- Meet the experts
- Unit overview
- Scaling manufacturing to meet demand (3 Questions)
- The role of automation (3 Questions)
- Centralized vs. distributed manufacturing (2 Questions)
- Cost of goods (2 Questions)
- Supply chain management (4 Questions)
- Meet the experts
- Unit overview
- The regulatory authorities (4 Questions)
- Regulatory expectations for traditional approval pathways (4 Questions)
- cGMP requirements (4 Questions)
- Product safety and effectiveness (4 Questions)
- Process validation (3 Questions)
- Meet the experts
- Wrap-up/Putting it all together
- Problem Set
- Exit Survey
Instructors
MIT Cambridge Frequently Asked Questions (FAQ's)
This is a nine-week online course with a weekly time commitment of five to seven hours.
This is a self-paced course.
Krystyn Van Vliet explains this online course.
An English video transcript is available for this online course.
The Massachusetts Institute of Technology created, offered, and delivered this course via the EDX platform.