Thomas Jefferson University and Temple University Partner to Offer MS in Advanced Biotherapeutics
The MS in Advanced Biotherapeutics: Manufacturing & Regulatory Affairs degrees combine theoretical and hands-on manufacturing-process and analytical experience with mandated regulatory and quality assurance expectations.
PHILADELPHIA — Thomas Jefferson University’s Jefferson Institute for Bioprocessing (JIB) and the Regulatory Affairs and Quality Assurance graduate program (RAQA) of Temple University’s School of Pharmacy announce the creation of exciting new Master’s programs which unite the strengths of two prestigious academic institutions.
Launching this fall semester, the MS in Advanced Biotherapeutics: Manufacturing & Regulatory Affairs degrees (ABMRA) will bridge the knowledge gap created by the shift in pharmaceutical production from traditional small molecule processes to biopharmaceutical production. The degrees utilize the highly knowledgeable and industry experienced staff at the JIB facility, in conjunction with the well-established and renowned adjunct faculty from Temple’s RAQA graduate program, to provide knowledge and career preparation in these areas.
There is currently a shortage of trained professionals familiar with biopharmaceutical manufacturing. The ground-breaking ABMRA degree will serve as a major vehicle for professional workforce development both locally and nationally.
Designed for professionals entering or advancing their careers in biopharmaceuticals, biologics, advanced vaccines and related industries, the ABMRA degrees will provide training and education to an inter-disciplinary group of students and primarily target industry professionals interested in advancing their careers in the ever-evolving world of regulatory affairs and quality assurance for biopharmaceuticals.
Dr. Parviz Shamlou, Vice President at Thomas Jefferson University and Executive Director of the Jefferson Institute for Bioprocessing, says that the greater Philadelphia region has established itself as a major center and a global engine for growth in cell and gene therapy and advanced vaccines in the 21st century. Significant investments have brought together all the elements that are essential for a global hub in cell and gene therapy: from investment in talent to investment in facilities, from world class translational research to advanced process development and cGMP manufacturing capability.
“One of the main components for the phenomenal success of the region in cell and gene therapy is JIB, which specializes in building competency through hands-on training and education as well as process development support to companies that are engaged in translating therapies from bench to market,” Dr. Shamlou says. “To do its work effectively and efficiently, JIB collaborates with other national and international centers of excellence in bioprocessing and related areas. The joint Master’s program with Temple University in Philadelphia is a great example of Jefferson’s pooled partnership initiative, which, I believe, will shape the way education will be delivered in the post pandemic era.”
Dr. Shamlou also highlights Temple’s decades of first-class experience in delivering education in the area of regulatory affairs.
“That experience beautifully and uniquely compliments what we do at JIB in biopharmaceutical and biologic process engineering,” he says. “We asked why not pull these two highly specialized resources together and create something new for the benefit of the students, the biopharma industries and the region.”
Wendy Lebing, Assistant Dean for Temple’s Regulatory Affairs and Quality Assurance program, shares Temple’s excitement to launch this partnership which will provide students from both schools a distinctive opportunity to accelerate and deepen their knowledge of biopharmaceutical production and regulations.
“This partnership will help to propel students’ career advancement in these cutting-edge technologies,” Lebing says. “Students will have the ability to earn certificates from either school while also earning a degree from either Temple or Jefferson, depending upon their preferred area of focus.
“These programs enable students to glean the expertise from two renowned Philadelphia Universities, discovering the niche within biopharmaceuticals that best fits their area of interest: manufacturing or regulatory affairs. Importantly, many of the courses are offered online to accommodate students’ work schedules.”
JIB will teach the manufacturing portion while Temple teaches the regulatory portion of the curriculum. Since the “process is the product” in biomanufacturing, a firm understanding of manufacturing principles is an important factor in developing and implementing quality-based strategies and policies that comply with regulatory oversight both nationally (FDA) and internationally.
Located within Thomas Jefferson University’s Kanbar College of Design Engineering & Commerce, JIB specializes in pre-clinical process development, product development, analytical, quality control, stability and release testing, world-class industry training, and strong credential programs through its university partnership.
JIB’s biopharmaceuticals and biologics support typically encompass development areas devoted to therapeutic programs, including proteins, monoclonal antibodies, fusion proteins, bispecifics, and antibody drug conjugates. JIB also supports cell and gene therapy, next generation vaccines and viral vectors.
“Individuals from both universities involved with the program worked tirelessly and selflessly to get all the administrative challenges resolved, focusing only on the benefits of the program for the students and the greater Philadelphia hub in cell and gene therapy,” says Dr. Shamlou. “The result is truly a template for future pooled partnership programs. We could not be happier with the outcome.”
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About Thomas Jefferson University
Thomas Jefferson University, founded in 1824 as the Jefferson Medical College, is today a national doctoral research university and a pioneer in transdisciplinary, professional education. Home of the Sidney Kimmel Medical College and the Kanbar College of Design, Engineering and Commerce, Jefferson is a preeminent academic institution delivering high-impact education in over 200 undergraduate and graduate programs to 8,400 students across 10 colleges. The University’s academic offerings now include architecture, business, design, engineering, fashion, health, medicine, science, social science and textiles. Jefferson is redefining the higher education value proposition with an approach that is collaborative and active; increasingly global; integrated with industry; focused on research across disciplines to foster innovation and discovery; and technology-enhanced. Student-athletes compete as the Jefferson Rams in the NCAA Division II Central Atlantic Collegiate Conference.
About Temple University’s RAQA Graduate Program
Established in 1901, the Temple University School of Pharmacy is known for the outstanding clinical pharmacy and graduate pharmaceutical science education it provides to diverse groups of students. With more than 8,500 pharmacy graduates, its degree programs include the Doctor of Pharmacy (PharmD) and thesis-based Master of Science (MS) and Doctor of Philosophy programs in the pharmaceutical sciences. In 1968, Temple worked with the local Philadelphia Food and Drug Administration (FDA) District and area pharmaceutical companies to pioneer the first graduate-level curriculum in Regulatory Affairs and Quality Assurance (RAQA). More than 50 years later, the RAQA graduate program is widely regarded as the most comprehensive and best-known program of its kind, offering more than 80 courses, 15 certificates in key industry areas, and four non-thesis, professional MS programs. The RAQA program was also one of the first to launch distance learning for Temple, offering courses to 27 corporate sites through videoconferencing in the late 1990s and early 2000s, before officially offering the RAQA MS through Internet delivery in 2006. The RAQA program offered a series of ground-breaking conferences entitled, “FDA and Industry in Dialogue” between 2000 and 2007, which resulted in a published book on conference topics in the collection of the Library of Congress. Since its inception, the RAQA program has had more than 2,600 MS recipients, many of whom hold leadership positions in the pharmaceutical, biopharmaceutical, medical device and related industries, as well as the FDA.