Spring 2025 Schedule  Advanced Biotherapeutics: Manufacturing and Regulatory Affairs (ABMRA) (Updated 12/19/24) Offered jointly with the Jefferson Institute of Biotechnology in Springhouse, PA, part of Jefferson University PDF of ABMRA Schedule

Order texts on-line: Temple U Bookstore

A strong science background is required to pursue the MS in Advanced Biotherapeutics: Manufacturing and Regulatory Affairs. This includes a science or engineering undergraduate or graduate degree.  To earn this degree, students complete a minimum of 15 credits in Temple's RAQA graduate program plus a minimum of 15 credits at the Jefferson Institute of Biotechnology in Springhouse, PA.  Most courses are in this 36-credit MS degree are online.  Students are strongly encouraged to enjoy the outstanding state-of-the-art equipment available at the Jefferson Institute of Biotechnology in Springhouse, PA, whenever possible.   

Students may earn the ABMRA degree either from Temple University OR from Thomas Jefferson University (but not both). Students wanting to focus on RA issues with biopharmaceuticals should pursue the TU degree; students wishing to focus on hands-on manufacturing issues of biopharmaceuticals should pursue the Jefferson degree.

Required Courses from Temple and Jefferson:

    Drug Development (5459) (Temple RAQA)
    Biologics/Biosimilars: A Regulatory Overview (5515) (Temple RAQA)
    Global CMCs - Biologics (5577) (Temple RAQA)
    Vaccines:  RA and QA Aspects (5572) (Temple RAQA)
    One approved RAQA elective for the ABMRA degree

     Bioprocess Engineering for Scientists (ENGR 609) (3 credits)
     Intro to Biopharmaceutical and Biologics Production (ENGR 621) (3 credits)
     Principles of Biopharmaceutical Process Engineering (ENGR 611) (3 credits)
     Biopharmaceutical Process Operations (ENGR 604) (3 credits)
     One approved JIB elective for the ABMRA degree

After completing required courses, students pursue 6 credits from either JIB or RAQA, depending on whether they earn the degree from Jefferson or Temple University.

Spring 2025 ABMRA Schedule

All RAQA online courses use Zoom. Temple provides Zoom for free to all registered Temple students.

Some ABMRA courses are also offered on-campus at RAQA's Fort Washington location. International students with F-1 visas are required to take on-campus courses or to pursue online courses in the Fort Washington Computer Lab and must take JIB courses at the Springhouse, PA, site of that program.

Required hardware
Our online courses are interactive, so you must have a webcam and microphone. Many laptops have built-in webcams and speakers. If you use a device that does not, you will be required to purchase them. 

If you're a new student, watch our online course tutorial. A password is given at the end which must be included on your registration form. 

After watching the tutorial, schedule a short Zoom meeting with Jessie Chen (jessie.chen@temple.edu) or David Brickett ([click-for-email]) to review how Zoom works, so you'll be ready for your first RAQA class meeting.

Proctorio is an online proctoring service that enables you to take exams at almost any location.  If a course uses Proctorio, all students in the class must use that service. 

You are expected to take proctored exams on the dates listed in the Schedule. There is a first time fee of $25 charged to any student who cannot take the exam on the designated date and requests a makeup test; in subsequent semesters, the fee increases to $50 per exam and then $100 per exam. For more information on proctoring and these fees, click here.

You must have a laptop or computer for RPNow exams. (Chrome notebooks, iPad, cell phones and other devices will not work). You must also have administrative access to your laptop or computer, which means you can install software. (Many office computers have built-in firewalls that will not allow software downloads.) Please check this before registering.

REQUIRED COURSES for the MS in Advanced Biotherapeutics: Manufacturing and RA (ABMRA)

Students pursuing the ABMRA MS must take required courses before registering for electives. Most required courses are only offered once a year.

REQUIRED RAQA COURSES

5459. Drug Development (990) crn: 42713 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring. 
6:00 pm - 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10. Meets 12 times plus final exam.  Make-ups, if needed, Apr 17 (Passover) and 24.
Proctored exam: Mar 6 (Proctorio)
Faculty: C. Ciliberto
Suggested text: Drugs: From Discovery to Approval, Ng, 3^rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
Not open to students who have completed RAQA 459.

5459. Drug Development (991) crn: 28687 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring. 
6:00 pm - 9:00 pm Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 (Passover) and 23.
Proctored exam:  Mar 5 (Proctorio)
Faculty:  J. Hayes
Required text: Drugs, From Discovery to Approval, 3rd edition, Rick Ng, ISBN-13:978-1118907276 or ISBN-10: 1118907272.
In addition, students will be required to choose one of the following texts and write a book review: 1. Ten Drugs, t. Hager, ISBN: 13-97: 1419735226; 2. For Blood and Money: Billionaires, Biotech, and the Quest for a Blockbuster Drug; Vardi; ISBN-13: ‎ 978-0393540956;  3. Making Medicine: Surprising Stories from the History of Drug Discovery, hardcover, July 2022; Veronese; ISBN-13:‎ 978-1633887534
Not open to students who have completed RAQA 459.

WEEKEND COURSE
5459. Drug Development (992) crn: 51026 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring. 
10:00 am – 1:00 pm Saturdays:  Jan 18, 25, Feb 1, 8, 15, 22, Mar 1, 8, 15, 22, 29, Apr 5. Meets 12 times plus final exam. Make-ups, if needed, Apr 12 and 19 (Passover).
Proctored exam: Mar 1 (Proctorio)
Faculty: D. Walsh
Required texts: 1) Drugs: From Discovery to Approval, Ng, 3^rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272), and 2) The Great Influenza, John M. Barry, Penguin 2004-5, (ISBN 0-14-303649-1)
Not open to students who have completed RAQA 459.

5572. Vaccines: RA and QA Issues (990) crn: 45613 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring. 
This course has limited seats. Send in your registration form right away.
Prerequisite: Drug Development (5459). Students are also expected to have a college-level background in general biology and chemistry and some knowledge of general microbiology and/or immunology.
6:00 pm - 9:00 pm Thursdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13 (recording), 20, 27, Apr 3, 10. Meets 12 times plus final exam. Make-ups, if needed, Apr 17 (Passover) and 24.
Proctored exam: Feb 27 (Proctorio) 
Faculty: K. Surowitz
Required texts: Do not purchase texts until AFTER hearing discussion in the first class: (1) Autism’s False Prophets, Paul Offit, 2008, Columbia University Press. Available in the Temple U Charles Library online.; (2) Epidemiology and Prevention of Vaccine Preventable Diseases, 13^th edition, U.S. Centers for Disease Control (CDC). Students may download individual chapters for free or purchase the paperback from the CDC; (3) The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and other Biologics, John Geigert, 3rd edition, 2019, Springer. Available in the Temple U Charles Library online; (4) Plotkin’s Vaccines, 7^th edition, 2018, Plotkin, Orenstein, Offit, Edwards, editors, Elsevior. Available in the Temple U Charles Library online.
Not open to students who have completed RAQA 572.

5577. Global CMCs – Biopharmaceuticals and Other Biologics (990) crn: 55328 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring.
6:00 pm - 9:00 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 (Passover) and 22.
Proctored exam: Feb 25 (Proctorio)
Faculty: J. Quinn
Required text: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, J. Geigert, 2024 https://link.springer.com/book/10.1007/978-3-031-31909-9

RAQA ELECTIVE COURSES: in the ABMRA DEGREE PROGRAM

5501. Development of Sterile Products (990) crn: 55322 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring.  
Prerequisite: a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course. RAQA students must include their resume for written permission to register.
6:00 pm - 9:00 pm Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9, 16 (Passover). Meets 12 times plus final exam. Make-ups, if needed, Apr 23 and 30.
Proctored exam:  Apr 16 (Proctorio)
Faculty: D. Casaburi
No required text:
Not open to students who have completed RAQA 501.

8005. Pharmaceutical Biotechnology (990) crn: 51044 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
Strong science background required, including a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course. RAQA students must submit their resume for permission to register.
6:00 pm – 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10, 17. Meets 12 times plus final exam. Make-up, if needed, Apr 24 and May 1.
Proctored exams: Mar 6 and Apr 17 (proctored through Zoom)
Faculty:  T. Parry
Required text: Pharmaceutical Biotechnology: Fundamentals and Applications, Crommelin, Sindelar & Meibohm, editors, any of the 3rd through 6^th editions should be ordered, Informa Healthcare 2007 (ISBN 10: 1420044370), ISBN 13 978 1420044379). Paperback recommended. Suggested: Biopharmaceutical: Biochemistry and Biotechnology, Walsh, G., 2nd edition, (ISBN 0 470 84327 6), available online. Students should have access to textbooks in biochemistry and/or molecular biology.
Not open to students who have completed Pharmaceutics 475.

5493. Sterilization Processes (990) crn: 53063 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring.
Prerequisite: strong science background. Submit resume with registration.
6:00 pm - 9:00 pm Mondays:  Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14 (Passover), 21.  Meets 12 times plus final exam. Make-up, if needed, Apr 28 and May 5.
Proctored exam: Apr 21 (Proctorio) 
Faculty: D. Casaburi
Required text: Validation of Pharmaceutical Processes, 3^rd edition, ISBN0:0-8493-7055-8.
Not open to students who have completed RAQA 493.

5512. Microbiological Concepts in Pharmaceutical Manufacturing (990) crn: 55321 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring.
Prerequisite: strong science background. Attach resume with registration form.
6:00 pm – 9:00 pm Thursdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 17 and 24.
Proctored exam:  Mar 13 (Proctorio)
Faculty:  R. Saha.
No required text.  All readings available on the Internet.
Not open to students who have completed RAQA 512.

5514. Regulatory eSubmissions (990) crn: 42720 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring. 
Prerequisite: Drug Development (5459) or Food and Drug Law (5592) or permission of the instructor.
6:00 pm - 9:00 pm Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam.  Make-ups, if needed, Apr 16 (Passover) and 23.
Proctored exam: Mar 5 (Proctorio)
Faculty: R. Arbaugh
No required text.

5544. Regulatory Intelligence (990) crn: 51035 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring. 
Prerequisites: Drug Development (5459) and Food and Drug Law (5592).
9:00 am – 3:30 pm Sundays (1/2 hour lunch):  Jan 19, Feb 2, 16, Mar 2, 16, 30. Meets 6 times plus final exam. Make-ups, if needed, Apr 13 and 27.
Proctored exam: Mar 2 (Proctorio)
Faculty: L. Bowen
No required text.

5574. Quality Management Systems (990) crn: 51029 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring.
Prerequisite: Drug Development (5459).
6:00 pm – 9:30 pm Mondays:  Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24 (recording), Mar 3, 10, 17, 24, Apr 7.  Meets 10 times plus final exam.  No class March 31. Make-ups, if needed, Apr 14 (Passover) and 21.
Proctored exam: Mar 3 (Proctorio).
Faculty: M. LaBruto
No required text.

5575. Regulatory Sciences:  Managing the Guidelines for Quality (990) crn: 53069 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring. 
Prerequisite: strong science background required.  Include resume with registration for approval.
5:30 pm – 8:30 pm Tuesdays:  Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam.  Make-ups, if needed, Apr 15 (Passover) and 22.
Proctored exam:  Mar 4 (Proctorio)
Faculty: T. Schultz
No required text.
Not open to students who have completed RAQA 580.

To register for the Online courses use:

Expectations of Online Students     

Registration Form for Online Courses

Registration Form for On-Campus Courses

Email your registration form to: QARAREG@temple.edu

OR, PRINT AND FAX YOUR REGISTRATION TO: 267.468.8565

OR, MAIL YOUR REGISTRATION TO:
Temple University
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034

Is this your first registration in the non-thesis MS program? If so, you must forward a RESIDENCY FORM.  Call RAQA at 267.468.8560 for instructions.

Will this be your fourth course in the MS program? If so, you must fax a Non-Matriculated Graduate Student Waiver