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Principles of Biomanufacturing: Using Biotechnology to Manufacture Medicines

Start Date: Feb 5, 2018
Duration: 6 Weeks
Price: $849

Course Description

The manufacturing of successful biologic medicines requires strong cross-functional collaboration. Yet many organizations are heavily siloed and fragmented communication across divisions can slow progress towards producing medicines for patients. Could your organization be working more effectively and efficiently?

Improve collaboration and expand your integrated thinking skills in biologic manufacturing in this six-week online course. You will learn from leading experts how engineering fundamentals connect to real-world application by examining case studies, touring facilities, and showing real pieces of biomanufacturing equipment in action. By the end of this course, you will understand how decisions made as early as product discovery can impact how a biologic is manufactured and delivered. You will also be able to answer questions such as:

  • How do you design biopharmaceutical medicines to be both effective and manufacturable?
  • How do you co-op cellular machinery to produce life-saving medicines?
  • How do you design reactors to keep the cellular factories happy and productive?
  • How do you remove cellular debris for the highest quality and most efficacious therapy?
  • Faster decision times could add risks associated with accelerated development of
    compounds, so how do you do all of this as efficiently as possible in a highly regulated
    environment?

Not sure this course is for you? Download a free Roadmap to Biomanufacturing PDF to get a sneak peek of what’s included in the course. Or join Dr. Paul Barone on Thursday, December 14th at 12:00 ET for a free webinar and Q&A session. RSVP for the free webinar here.

What You'll Learn

  • Develop an integrated understanding of how biopharmaceutical are made from start to finish and how decisions along the way are interrelated.
  • Discover how small changes in a protein therapeutic may change its efficacy, safety and manufacturability.
  • Understand the method by which living cells are engineered to produce complex therapeutic proteins.
  • Explore the way in which reactors are designed to support the growth of living cells that produce a target therapeutic.
  • Learn how protein therapeutics are purified and how previous manufacturing steps inform how this is performed.
  • Identify the keys to manufacture biopharmaceuticals in a regulated environment.
  • Analyze examples and case studies highlighting key biomanufacturing challenges.

Want to purchase this course for a group?

You can purchase enrollment codes for this course to distribute to your team

Purchase for a Group

Instructors

J. Christopher Love

J. Christopher Love Associate Professor of Chemical Engineering Koch Institute for Integrative Cancer Research at MIT

Dr. Paul W. Barone

Dr. Paul W. Barone Director, Biomanufacturing Research Program (BioMAN) MIT Center for Biomedical Innovation (CBI)

Dr. Stacy L. Springs

Dr. Stacy L. Springs Senior Director of Programs, MIT Center for Biomedical Innovation (CBI)

WHY MIT XPRO?

It’s professional development– the MIT way.

MIT xPRO courses provide professional development opportunities to individuals, teams, and companies across the world. Leveraging the latest learning technologies, MIT xPRO courses and programs are designed to provide a high quality education experience while accommodating your busy life.

MIT xPRO learners are not only scientists, engineers, technicians, managers, and consultants– they are change agents. They take the initiative, push boundaries, and define the future.

EARN A CERTIFICATE OF COMPLETION AND CEUS

Learners who successfully complete the course and all assessments will receive a Certificate from MIT and 3 Continuing Education Units (CEUs). This course does not carry MIT credits or grades, however, a 70% pass rate is required in order to receive the certificate as well as passing grades on five assessments.

WHO SHOULD PARTICIPATE

This course is designed for scientists and engineers working in biopharmaceutical development, as well as manufacturing managers, process validation staff, quality assurance professionals. Because of the broad nature of the information, the course is well suited for both early career professionals and senior managers. The faculty strongly recommend participants have a basic understanding of organic chemistry, calculus, and molecular biology.

COURSE REVIEWS

“A great course to understand modern bioreactor-based manufactory process. There are historical references and insights, a light introduction to biomolecules, then the focus is put on the design and control of bioreactors; at the end, several techniques of purification are studied. Very interesting course, well structured.” – Claudio Felicioli

“This course gives an overview of the entire process of biopharmaceutical manufacturing, from the very beginning until drug substance bottling. Highly recommended for anyone interested in this subject, in my case, Chemical Engineer working in the Biopharmaceutical Industry, this course was very useful.” – Anonymous Learner

“An excellent course for anyone interested in how recombinant biologic medicines are designed & produced. The instructors are excellent and quite accessible for help in the forum.” – Dan Hill

COURSE OUTLINE

Course materials blend the following pedagogical strategies to best achieve the learning objectives of the course and individual modules:

  • Instructivism: Teacher-centered learning where the instructors present relevant content (tutorial videos enhanced with animation and graphics). Students will test their knowledge through graded tests.
  • Constructivism: Learning by doing approach. We encourage learners to construct their own understanding through solving the mandatory and optional case studies and practicing.
  • Social constructivism: Learning through social interactions and communication. You will be able to discuss with your peers in the discussion groups, and evaluate and get reviews from your peers through two compulsory case studies.
  • Connectivism: Connecting with others and extending your knowledge through communication. You will be able to expand and share your knowledge with others through the Discussion group, and course groups on Facebook, and LinkedIn.

  • Week 1: Roadmap for Modern Biomanufacturing

    • Roadmap to Modern Biomanufacturing
    • Using Cells for Manufacturing
    • Proteins as Therapeutics
    • Course Structure and Expectations

    Week 2: Protein Structure & Function

    • Protein Structure
    • Post Translational Modifications
    • Function Examples

    Week 3: Cell Line Development

    • Design of DNA Vectors for Protein Expression
    • Selection of a Host for Production
    • Vector Design for Mammalian Hosts
    • Clonal Selection

    Week 4: Upstream Bioreactors

    • Process Yield Calculation
    • Bioreactor Design Features
    • Mechanical Agitation
    • Upstream Process Development
    • Media Development

    Week 5: Downstream Processing

    • Cell Harvest
    • Filtration Unit Operation
    • Depth Filtration
    • Ultrafiltration

    Week 6: Downstream Processing & Regulation

    • Chromatography
    • Viral Clearance in Downstream Purification
    • Process Control, Process Validation, and Product Testing
    • Quality by Design
    • Manufacturing Process Variants

FREQUENTLY ASKED QUESTIONS

What is the time commitment for this course?

MIT xPRO courses are designed to fit the schedules of busy professionals. The course requires a time commitment of 3-5 hours a week comprised of videos, assigned reading, and assignments.

Each video module is pre-recorded enabling you to watch it anytime. While you may complete most of the program as quickly as you wish, most participants find it beneficial to adhere to the weekly schedule and participate in online discussion forums along the way.

What are the browser or other technical requirements?

Access our courses requires an Internet connection, as videos are only available via online streaming, and cannot be downloaded for offline viewing. Please take note of your company's restrictions for viewing content and/or firewall settings.

Our courseware works best with current versions of Google Chrome, Firefox, or Safari, or with Internet Explorer version 10 and above. For the best possible experience, we recommend switching to an up-to-date version of Chrome. If you do not have Chrome installed, you can get it for free here: http://www.google.com/chrome/browser/.

We are unable to fully support access with mobile devices at this time. While many components of your courses will function on a mobile device, some may not.

Who can register for this course?
U.S. sanctions do not permit us to offer this course to learners in or ordinarily residing in Iran, Cuba, Sudan, and the Crimean region of Ukraine.

How do I register for the course?
Simply click the "Enroll Now" button above. You may be prompted to first register for a MIT xPRO account if you do not have one already. Complete this process, then continue with enrollment process.

How do I register a group of participants?
For a group of 5 or more individuals, you can pay via invoice. To be invoiced, please email mitxpro@mit.edu with the number of individuals in your group, and instructions to register will be provided. Please note that our payment terms are net zero, and all invoices must be paid prior to the course start date. Failure to remit payment before the course begins will result in removal from the course. No extensions or exceptions will be granted.

What is the registration deadline?
Individual registrations must be completed by February 19, 2018.

How should I pay?
Individual registrants must complete registrations and pay online with a valid credit card at the time of registration. MIT xPRO accepts globally recognized major credit or debit cards that have a Visa, MasterCard, Discover, American Express or Diner's Club logo. Invoices will not be generated for individuals, or for groups of less than 5 people. However, all participants will receive a payment receipt. Payment must be received in full; payment plans are not available.

When will I get access to the course site?
Instructions for accessing the course site will be sent to all paid registrants via email prior to the course launch date. In order to receive these instructions, please add mitxpro@mit.edu to your “trusted senders” list. If you have not received these instructions by the course start date, visit your account dashboard to login and start the course on the advertised course start date.

I need to cancel my registration. Are there any fees?
Cancellation requests must be submitted to mitxpro@mit.edu.Cancellation requests must be submitted to mitxpro@mit.edu. Cancellation requests received after February 9, 2018 will not be eligible for a refund. To submit your request, please include your full name and order number in your email request. Refunds will be credited to the credit card used when you registered and may take up to two billing cycles to process.

Can I transfer/defer my registration for another session or course?
Admission and fees paid cannot be deferred to a subsequent session; however, you may cancel your registration and reapply at a later date.

Can someone else attend in my place?
We cannot accommodate any substitution requests at this time. Please review the time commitment section and course schedule

COURSE QUESTIONS

How do I know if this course is right for me?
Carefully review the course description page, which includes a description of course content, objectives, and target audience, and any required prerequisites.

Are there prerequisites or advance reading materials?
The course is open to any interested participant. No advance reading is required. The faculty strongly recommend participants have a basic understanding of organic chemistry, calculus, and molecular biology.

How long is the course?
The course is held over six weeks. Lectures are pre-taped and you can follow along when you find it convenient, as long as you finish all required assignments by March 18, 2018. You may complete all assignments before the due date, however, you may find it more beneficial to adhere to a weekly schedule so you can stay up-to-date with the discussion forums.

How long will the course material be available online?
The materials will be available to registered and paid participants until June 19, 2018. No extensions may be granted.

What reference materials will be available at the end of the course?
Learners will have 90-day access to the archived course (includes videos, discussion boards, content, and Wiki).

What materials will participants keep at the end of the course?
Learners will take away program materials, and resources presented in the course Wiki, including downloadable case study activities for you to work on in your spare time during or after the course.

Will I receive a Course Certificate?
Learners who successfully complete the course and all assessments will receive a Certificate from MIT. This course does not carry MIT credits or grades, however, a 70% pass rate is required in order to receive the certificate.

Will I receive MIT credits?
This course does not carry MIT credits. MIT xPRO offers non-credit/non-degree professional programs for a global audience. Learners may not imply or state in any manner, written or oral, that MIT or MIT xPRO is granting academic credit for enrollment in this professional course. Letter grades are not awarded for this course.

Will I earn Continuing Education Units (CEUs)?
Course learners who successfully complete all course requirements are eligible to receive 3 Continuing Education Units (CEUs) from MIT. CEUs may not be applied toward any MIT undergraduate or graduate level course.

After I complete this course, will I be an MIT alum?
Participants who successfully complete this course are considered MIT xPRO Alumni. Only those who complete an undergraduate or graduate degree are considered MIT alumni.

Are video captions available?
Each video for this course has been transcribed and the text can be found on the right side of the video when the captions function is turned on. Synchronized transcripts allow students to follow along with the video and navigate to a specific section of the video by clicking the transcript text. Students can use transcripts of media-based learning materials for study and review. In addition, we include a complete course transcript in a single PDF file that allows for easy reference.

I have never taken a course on the edX platform before. What can I do to prepare?
Prior to the first day of class, participants can take a demonstration course on edx.org that was built specifically to help students become more familiar with taking a course on the edX platform.

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