Make an Appointment 617-984-1700
Apply Now
Support QC
Language

Biotechnology & Good Manufacturing Practice Certificate

Certificate

Overview

The Biotechnology GMP certificate program is designed to prepare students for entry-level positions in the biomanufacturing industry. Students will develop a broad laboratory science- based background through courses focused in the life and chemical sciences, and will obtain industry-specific knowledge in the areas of quality control (QC), process development (PD), and upstream and downstream processing, all while following current, good manufacturing practices (cGMP). In addition, students will learn valuable laboratory techniques and instrumentation, and develop critical thinking skills. Upon successful completion of the program, students may enter the workforce directly as entry-level laboratory technicians or research assistants.

Program Outcomes

At the completion of this program, the student should be able to:

  • Practice ethical standards of integrity, honesty, and fairness in scientific practices and professional conduct.
  • Apply appropriate computer software and hardware skills to accomplish biotechnology lab tasks.
  • Demonstrate technical knowledge of specialized techniques and instrumentation relating to biomanufacturing.
  • Communicate thoughts, orally and in writing, in a clear well-organized manner that effectively informs scientific principles and lab techniques.
  • Perform basic molecular biology & biochemical techniques.
  • Apply GMP documentation to biomanufacturing.
  • Perform all aspects of upstream and downstream processing in biomanufacturing.
  • Develop critical thinking skills to solve complex scientific problems.

Biotech GMP Certificate Semester Path

Academic Division of Allied Health

Biotechnology & Good Manufacturing Practice Certificate Courses
    •  
    • Code
    • Course
    • Credits
    • BTC 101
    • Introduction to Biotechnology
    • 4
    This course is designed to introduce the student to the role of biotechnology in the fields of medicine, environmental science, forensics, microbes and agriculture. The student will explore the theory, tools and application behind the genetics involved in these fields. This lab-based, hands-on course will expose the student to the techniques and equipment utilized in scientific laboratories around the world. Prerequisites: CHE 121/131 and/or BIO 111/121. One course allowed concurrently.
    • BTC 102
    • Buffer and Media Preparation*
    • 2
    This laboratory based course is designed to introduce the student to the skills required to prepare chemical buffers and cell culture media for use in the bio manufacturing industry. The student will become skilled in the techniques and equipment necessary to prepare high quality buffers and media for use in the manufacturing of protein products. The goal of this course is to manufacture buffers and media following strict aseptic techniques while adhering to current good manufacturing practices (cGMP). Quality control methods will stringently test the buffering capacity, ionic strength, and purity of products.
    • BTC 103
    • Technical Writing in Bio manufacturing*
    • 2
    This course in technical Writing is designed to introduce the student to the complexity of documentation in the bio manufacturing environment. Students will discover the role of Quality Assurance in the day to day operations of the manufacturing facility. Following the Code of Federal Regulations (CFR), students will learn the process of writing and following standard operating procedures (SOPs), deviation reports, corrective action/prevention action reports (CAPAs), and change control reports among others. Students will design a manufacturing company following strict CFR guidelines. The importance of integrity in documentation will be emphasized for maintaining high quality products.
    • BTC 202
    • Protein Purification
    • 2
    This course is designed to give students an in-depth understanding of protein purification. Students will learn the physical and chemical properties of various protein purification media used in bio manufacturing and how those properties can be utilized for purifying proteins. Students will be engaged in real world applications relating to the chromatographic techniques involved in preparing media, packing columns, calibrating columns, and equilibrating columns. Students will learn how to design protein purification schemes based upon their knowledge of the intrinsic properties of proteins. All purified proteins will be validated using electrophoretic and spectrophotometric techniques.
    • BTC 220
    • Biomanufacturing I
    • 4
    This course is the second in the series of cornerstone courses in Biotechnology and Good Manufacturing Practice and the first of three courses in Biomanufacturing. This lab- based course is designed to introduce the student to the high-tech world of manufacturing prescription drugs. The course begins with an overview of biomanufacturing, its rapid growth and the industries need for well-trained employees. We examine the need for the Food and Drug Administration (FDA) and their requirements for current good manufacturing practices (cGMP). The student will become skilled in the techniques and equipment necessary to manufacture a recombinant protein. The goal of the course is to manufacture a mammalian protein in bacteria following cGMP’s and standard operating procedures through upstream and downstream processes. Quality control methods will stringently test the protein product and validate its purity. Prerequisites: CHE121, BIO111, and BTC101.
    • BTC 230
    • Biomanufacturing II
    • 4
    This course is the third in the series of cornerstone courses in Biotechnology and Good Manufacturing Practice and the second of three courses in Biomanufacturing. This lab- based course is designed to give students experience in various aspects of biomanufacturing including but not limited to: Process development, Quality Control, Environmental Health and Safety, and Upstream and Downstream Processing. The course begins with the aseptic techniques involved in the culturing and preservation of mammalian and yeast cells. Scale-up techniques (upstream processing) will then be used to culture a 1 milliliter volume of cells (106) into 3-10 liter columns containing many trillions of cells (1012). An in- depth discussion of downstream processing techniques such as tangential flow filtration and protein purification systems will be utilized to purify a protein product (drug) from the cell media. Strict adherence to current good manufacturing practices (cGMP) will be followed and the protein products will be tested and validated for purity. Prerequisites: CHE 121, BIO 111, BIO 251, BTC 101, BTC 201, BTC 220.
    • BTC 240
    • Seminar in Biotechnology
    • 1
    Seminar-style capstone course covering professional topics in Biotechnology and Good Manufacturing Practice, including but not limited to: discussion of emerging technologies, innovations, and new products that are noteworthy to the biotechnology industry; the steps involved with the regulatory approval process for a new biotechnology-derived product, and; key issues associated with adequate quality-control systems, assays and stability for novel biotechnology products. Students, working in teams, will give written and oral presentations on case studies that attempt to predict products derived from the new innovations and discoveries. The objective of the course is to give the student insight into the process of translating scientific discovery into innovative products. Prerequisite: BTC 220.
    • MAT 103
    • College Algebra
    • 3
    This college level algebra course expands upon a student’s knowledge by further developing algebraic concepts. Topics include graphing equations with an introduction to functions, factoring polynomials, operations on rational functions, simplifying rational exponents, and solving quadratic equations. Students will be required to complete homework assignments using a web-based computer program. Prerequisite: Appropriate score on the placement test or successful completion of MAT 097.

Take the Next Step