Overview

The regulatory framework required for the approval of biotechnology-derived products (or biologics) is lengthy, rigorous, and highly complicated. This Graduate Certificate - Biopharmaceutical Manufacturing And Regulatory Affairs program at Temple University delves into the complex regulations governing the development, manufacturing, and distribution of such products.

Key feature

Through completion of the certificate, whether post-baccalaureate or post-master's, students understand the following:

the pharmaceutical science behind the discovery of biotechnology products, including biologics, biosimilars, and biopharmaceuticals;
the requirements for sourcing and testing materials used in the production of biotechnology products;
the technologies and unique considerations associated with the manufacturing and distribution of biotechnology products;
the applicable regulations involved with biotechnology products; and
the processes used to sterilize biotechnology products, including regulatory requirements for thermal, gaseous, radiation, filtration, and aseptic processing.

Programme Structure

Courses include:

Biotechnology: Bioprocess Basics

Biologics/Biosimilars: A Regulatory Overview

Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics

Production of Sterile Parenterals

Sterilization Processes

Development of Sterile Products
Microbiological Concepts in Pharmaceutical Manufacturing

Key information

Duration

Full-time
- 36 months

Start dates & application deadlines

Starting 2026-08-26 00:00:00

Apply anytime.
Starting 2027-01-13 00:00:00

Apply anytime.

More details

Fall and Spring admissions are on a rolling basis

Language

English

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IELTS

6.5

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Credits

15 SCH

Delivered

On Campus, Online

Campus Location

Philadelphia, United States

Disciplines

Pharmacy Health Sciences Production and Manufacturing Engineering View 73 other Masters in Production and Manufacturing Engineering in United States

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Academic requirements

We are not aware of any specific GRE, GMAT or GPA grading score requirements for this programme.

English requirements

Duolingo English Test

110

Take A Free Practice Test!

TOEFL^® IBT

Schedule TOEFL®

PTE Academic

Schedule a PTE test!

IELTS

6.5

Prepare for Your English Test

Cathoven AI IELTS Preparation

Learn your IELTS Score

AI-powered IELTS feedback. Clear, actionable, and tailored to boost your writing & speaking score. No credit card or upfront payment required.

Trusted by 300k learners
98 accuracy using real exam data
4.9/5 student rating

Other requirements

General requirements

Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a BS degree in Biochemistry, Biology, Chemistry, Physics or a health-related discipline

Tuition Fees

Tuition fees are shown in and the most likely applicable fee is shown based on your nationality.

International Applies to you

Applies to you

Non-residents

5930 USD / year

≈ 5930 USD / year
Out-of-State

5930 USD / year

≈ 5930 USD / year
Domestic

Applies to you

In-State

5930 USD / year

≈ 5930 USD / year

Living costs

Philadelphia

United States

1313 - 2284 USD / month

The living costs include the total expenses per month, covering accommodation, public transportation, utilities (electricity, internet), books and groceries.

Financing

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Funding

Win a €10000 Scholarship! Deadline: 30 June 2020

Embark on your journey with the Studyportals Scholarship! We're giving away a total of 20,000 euros to help you achieve your dream of studying abroad.

Win a €10000 Scholarship! Deadline: 30 June 2020

Embark on your journey with the Studyportals Scholarship! We're giving away a total of 20,000 euros to help you achieve your dream of studying abroad.

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Scholarships Information

Below you will find Master's scholarship opportunities for Graduate Certificate - Biopharmaceutical Manufacturing And Regulatory Affairs.

Available Scholarships

You are eligible to apply for these scholarships but a selection process will still be applied by the provider.

On this page

About

Overview

Key feature

Programme Structure

Key information

Duration

Start dates & application deadlines

Language

Prepare for Your English Test

Credits

Delivered

Campus Location

Disciplines

What students do after studying

Academic requirements

English requirements

Prepare for Your English Test

Other requirements

General requirements

Tuition Fees

International Applies to you

Domestic

Living costs

Philadelphia

Financing

Funding

Scholarships Information

Available Scholarships

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