Biotechnology/Biomanufacturing

The Biotechnology/Biomanufacturing program at Mount Wachusett Community College provides students with the opportunity to earn a Certificate in Biotechnology/Biomanufacturing, a Certificate in Analytical Laboratory Quality Systems Certificate, an Associate Degree in Biotechnology/Biomanufacturing or an Associate Degree Biotechnology/Biomanufacturing with a Analytical Laboratory Quality Systems Concentration.  Upon completion of one of these programs, students are prepared for positions in many manufacturing and engineering settings.  During the course of study, students will develop occupational knowledge and the laboratory skill sets necessary to succeed in the technical field of biotechnology and biomanufacturing.

Analytical Laboratory and Quality Systems Certificate (ALQC)

Manufacturing quality products and/or providing quality services (e.g. testing services) are essential for companies to thrive in today’s global marketplace.  Quality Assurance and Quality Control functions are present in organizations to maintain both customer satisfaction and loyalty, while reducing the risk and costs of replacing faulty goods or incorrect analysis results.  Companies build a reputation for quality by: a) following regulations such as the US FDA requirements for medical devices and pharmaceuticals, or b) gaining accreditation with a recognized quality standard such as ISO 9001, published by the International Organization for Standardization.  The Analytical Laboratory and Quality Systems curriculum will prepare students to gain entry level positions as  quality technicians for organizations requiring measurements and documentation of quality attributes following standardized and/or regulated procedures.  Example positions include Quality Inspectors, Document Control Technicians, Laboratory Technicians and Manufacturing Production Technicians.  The ALQC curriculum offers excellent academic and skill development for anticipated positions in either manufacturing or service organizations.  For more information please call 978-630-9576.

Year 1
FallCredits
CHE 107General Chemistry I 4
BTC 102Basic Laboratory Techniques 3
AQS 110Introduction to Quality and Metrology 4
MAT 162Introduction to Functions & Modeling (Formerly MAT 134) 4
Spring
BTC 191Quality and Compliance 3
CHE 180Instrumental Analysis 4
Professional Elective  3-4
Professional Elective  3
 Total Credits: 28-29

Professional Electives

Credits
AQS 115Industry Overview and Auditing Principles3
AQS 200Conducting Root Cause Investigations3
BTC 185Industrial Microbiology4
BUS 125Communication For Business And Industry3
CAD 101Introduction To CAD3
CHE 108General Chemistry II4
CIS 121Spreadsheet Applications3
ENG 106Technical Writing3
MET 105Blueprint Reading3
PLT 220Statistical Process Control3

Campus

This program is offered primarily on the Devens campus.

Transfer options

This program is intended for immediate career entry. Courses completed as part of this certificate program can be applied to the Biotechnology/Biomanufacturing Degree.

Career options/Earning potential

For career options, please click here.

Gainful Employment Program Disclosure Information

For gainful employment information, please click here.

Biotechnology/Biomanufacturing Certificate (BTC)

Biotechnology uses living organisms, usually microscopic, to manufacture drugs or other chemicals for the purpose of enhancing medical care or altering a process which improves living conditions for the general population. Careers in biotechnology/biomanufacturing will continue to advance. The Biotechnology/Biomanufacturing certificate curriculum will offer excellent academic and skill development for anticipated positions in the biotechnology industry. For more information, please call 978-630-9572.

Year 1
FallCredits
BTC 101Introduction To Biotechnology (With Application) 4
BTC 102Basic Laboratory Techniques 3
CHE 107General Chemistry I 4
Spring
BTC 191Quality and Compliance 3
BTC 120Biotechnology Experience: Biomanufacturing 4
BTC 185Industrial Microbiology 4
Professional Elective (see list below)  3-4
 Total Credits: 25-26

Professional Electives

Credits
BIO 109Biology I4
BIO 170Cell Biology4
BTC 110Biotechnology Experience: Concepts And Procedures4
CHE 108General Chemistry II4
CHE 180Instrumental Analysis4
CIS 127Computer Technologies3
ENG 106Technical Writing3
HUM 212Medical Ethics3
MAS 208Principles Of Pharmacology3
MAT 143Statistics (or higher)4

Campus

This program is offered primarily on the Devens campus.

Helpful hints

Biotechnology/ biomanufacturing will require a substantial background and interest in science and mathematics. Potential students should recognize the need for a strong background and may be required, through testing and an interview with the admissions office, to enroll in math and science courses as prerequisites.

Special requirements

Technical standards must be met with or without accommodations. Students will need a grade of C or better in all BTC courses.

Transfer options

This program is intended for immediate career entry. Courses completed as part of this certificate program can be applied to the Biotechnology/Biomanufacturing Degree.

Career options/Earning Potential

For career options, please click here.

Gainful Employment Program Disclosure Information

For gainful employment information, please click here.

Biotechnology/Biomanufacturing Degree (BTD)

Biotechnology uses living organisms, usually microscopic, to manufacture drugs or other chemicals for the purpose of enhancing medical care or altering a process which improves living conditions for the general population. Careers in biotechnology/biomanufacturing will continue to advance. The biotechnology/biomanufacturing curriculum will offer excellent academic and skill development for anticipated positions in the biotechnology industry. For more information, please call 978-630-9572.

Year 1
FallCredits
BIO 109Biology I 4
CHE 107General Chemistry I 4
ENG 101College Writing I 3
BTC 102Basic Laboratory Techniques 3
Spring
BTC 101Introduction To Biotechnology (With Application) 4
CHE 108General Chemistry II 4
CIS 127Computer Technologies 3
ENG 102College Writing II 3
MAT 162Introduction to Functions & Modeling (Formerly MAT 134) (OR HIGHER) 4
Year 2
Fall
BTC 185Industrial Microbiology 4
HUM 212Medical Ethics 3
BTC 170Cell Culture Techniques 4
Professional Elective (see list below)  3-4
Spring
BTC 120Biotechnology Experience: Biomanufacturing 4
BTC 200Biotechnology Seminar 3
BTC 191Quality and Compliance 3
Social Science Elective 1 3
Health Elective (see list below)  2-4
 Total Credits: 61-64
1

Social Science Electives: ANT, ECO, GEO, HIS, POL, PSY, SOC, SSC

Professional Electives

Credits
AQS 110Introduction to Quality and Metrology4
BIO 110Biology II4
BIO 170Cell Biology4
BTC 110Biotechnology Experience: Concepts And Procedures4
CHE 180Instrumental Analysis4
CHE 207Organic Chemistry I4
ENG 106Technical Writing3
MAS 208Principles Of Pharmacology2
MAT 163Pre-Calculus (or higher)4

Health Electives

Credits
BIO 101Introduction To Nutrition (formerly NUT101)3
BIO 103Human Health And Disease3
BIO 112Biology Of Cancer3
BIO 230Nutrition, Health, And Sustainability3
CHC 101Complementary Health Care3
CHC 108Transforming Stress3
CHC 220Mind-Body-Spirit Connection3
EXS 102Principles Of Anatomy And Kinesiology3
EXS 201Exercise Science And Nutrition4
PER 126Fitness And Wellness2
PER 127Weight Management through Walking and Resistance Training2
PER 130Health, Fitness, And Wellness3

Campus

This program is offered primarily on the Devens campus.

Helpful hints

Biotechnology/ biomanufacturing will require a substantial background and interest in science and mathematics. Potential students should recognize the need for a strong background and may be required, through testing and an interview with the admissions office, to enroll in math and science courses as prerequisites.

Transfer options

For transfer options, please click here. It is recommended that you also consult with your academic advisor.

Special requirements

Technical standards must be met with or without accommodations. Students will need a grade of C or better in all BTC courses.

Career options/Earning potential

For career options, please click here.

Biotechnology - Analytical Laboratory and Quality Systems Concentration (BTDQ)

The Biotechnology/Biomanufacturing degree with Quality Concentration will prepare students to gain entry level technician positions in biotechnology industries or general manufacturing and/or service organizations requiring measurements and documentation of quality attributes following standardized and/or regulated procedures. Manufacturing quality products and/or providing quality services (e.g. testing services) are essential for companies to thrive in today’s global marketplace.  Quality Assurance and Quality Control functions are present in organizations to maintain both customer satisfaction and loyalty, while reducing the risk and costs of replacing faulty goods or incorrect analysis results.  Companies build a reputation for quality by: a) following regulations such as the US FDA requirements for medical devices and pharmaceuticals, or b) gaining accreditation with a recognized quality standard such as ISO 9001, published by the International Organization for Standardization.   Example positions include Calibration Technicians, Quality Control Analysts, Laboratory Technicians, Manufacturing Production Technicians and Research & Development Technicians.  The BTDQ curriculum offers excellent academic skill development in both biotechnology and quality systems.   The biotechnology/biomanufacturing curriculum combined with the quality systems curriculum offer excellent academic and skill development for anticipated positions in either manufacturing or service organizations.   For more information, please call 978-630-9576.

Year 1
FallCredits
AQS 110Introduction to Quality and Metrology 4
BTC 102Basic Laboratory Techniques 3
CIS 127Computer Technologies 3
CHE 107General Chemistry I 4
MAT 162Introduction to Functions & Modeling (Formerly MAT 134) 4
Spring
BTC 101Introduction To Biotechnology (With Application) 4
BIO 109Biology I 4
ENG 101College Writing I 3
BTC 191Quality and Compliance 3
Social Science Elective 1 3
Year 2
Fall
BTC 185Industrial Microbiology 4
AQS 200Conducting Root Cause Investigations 3
BTC 120Biotechnology Experience: Biomanufacturing 4
HUM 212Medical Ethics 3
ENG 102College Writing II 3
Spring
BTC 200Biotechnology Seminar 3
BTC 170Cell Culture Techniques 4
CHE 180Instrumental Analysis 4
Health Elective  2-4
 Total Credits: 65-67
1

 Social Science Electives:  ANT, ECO, GEO, HIS, POL, PSY, SOC, SSC

Health Electives

Credits
BIO 101Introduction To Nutrition (formerly NUT101)3
BIO 103Human Health And Disease3
BIO 112Biology Of Cancer3
BIO 230Nutrition, Health, And Sustainability3
CHC 101Complementary Health Care3
CHC 108Transforming Stress3
CHC 220Mind-Body-Spirit Connection3
EXS 102Principles Of Anatomy And Kinesiology3
EXS 201Exercise Science And Nutrition4
PER 126Fitness And Wellness2
PER 127Weight Management through Walking and Resistance Training2
PER 130Health, Fitness, And Wellness3

Campus

This program is offered primarily on the Devens campus.

Helpful hints

Biotechnology/ biomanufacturing will require a substantial background and interest in science and mathematics. Potential students should recognize the need for a strong background and may be required, through testing and an interview with the admissions office, to enroll in math and science courses as prerequisites.

Transfer options

For transfer options, please click here. It is recommended that you also consult with your academic advisor.

Special requirements

Technical standards must be met with or without accommodations. Students will need a grade of C or better in all BTC courses.

Career options/Earning potential

For career options, please click here.

Program Competencies for BTD

Upon graduation from this program, students shall have demonstrated the ability to:

  • Use the language of biotechnology.
  • Articulate, read and follow an SOP (standard operating procedure).
  • Conduct the mathematic and computational operations involved in biotechnology including use of applicable computer programs.
  • Understand and apply the regulatory requirements of cGMP (current Good Manufacturing Practices).
  • Understand the basic biology and chemistry behind the manufacturing processes.
  • Perform laboratory skills used in biotechnology and biomanufacturing.
  •  

Program Competencies for BTDQ

Upon graduation from this program, students shall have demonstrated the ability to:

  • Use the language of biotechnology.
  • Conduct the mathematic and computational operations involved in biotechnology including use of applicable computer programs.
  • Understand the basic biology and chemistry behind the manufacturing processes.
  • Perform laboratory skills used in biotechnology and biomanufacturing.
  • Communicate technical information in written and oral form, including use of electronic media.
  • Comfortably work with a variety of measurement systems and associated units of measure (e.g. SI Units, concentration, physical constants, etc.).
  • Describe and use various measurement methods and define and distinguish between various measurement characteristics, including variability, sensitivity, repeatability, reproducibility, bias, linearity, stability, etc., as they are used for basic measurements.
  • Perform, identify and define common elements of calibration procedures, such as required equipment, revisions, equipment listing, environmental considerations and restraints, etc.
  • Understand, identify and correct for error sources that can affect measurement results, including drift, bias, operator error, environment, etc.
  • Identify various aspects of traceability and define and distinguish between various types of standards, and identify when to use them in various situations.
  • Define and describe document control in terms of maintaining the integrity and confidentiality of various calibration records, including audit results, staff training, uncertainty budgets, customer data, etc., in both electronic and paper formats.
  • Define and distinguish between various components of a quality system, including management and customer focus, employee training and development, continuous process improvement, etc.
  • Select and apply the seven basic quality tools: flowcharts/process maps, check sheets, Pareto diagrams, cause and effect diagrams, scatter diagrams, control charts, and histograms.
  • Be able to articulate, read and follow a SOP (standard operating procedure).
  • Define basic audit types (e.g., internal, external, product, process) and roles (e.g., auditor, auditee, client), and identify basic components of an audit (e.g., audit plan, audit purpose, audit standard) and describe various auditing tools (e.g., checklist, final report).
  • Be able to understand and apply the regulatory requirements of cGMP (current Good Manufacturing Practices) and ISO-13485 certification.

Program Competencies for ALQC

Upon graduation from this program, students shall have demonstrated the ability to:

  • Communicate technical information in written and oral form, including use of electronic media.
  • Comfortably work with a variety of measurement systems and associated units of measure (e.g. SI Units, concentration, physical constants, etc.).
  • Describe and use various measurement methods and define and distinguish between various measurement characteristics, including variability, sensitivity, repeatability, reproducibility, bias, linearity, stability, etc., as they are used for basic measurements.
  • Perform, identify and define common elements of calibration procedures, such as required equipment, revisions, equipment listing, environmental considerations and restraints, etc.
  • Understand, identify and correct for error sources that can affect measurement results, including drift, bias, operator error, environment, etc.
  • Identify various aspects of traceability and define and distinguish between various types of standards, and identify when to use them in various situations.
  • Define and describe document control in terms of maintaining the integrity and confidentiality of various calibration records, including audit results, staff training, uncertainty budgets, customer data, etc., in both electronic and paper formats.
  • Define and distinguish between various components of a quality system, including management and customer focus, employee training and development, continuous process improvement, etc.
  • Select and apply the seven basic quality tools: flowcharts/process maps, check sheets, Pareto diagrams, cause and effect diagrams, scatter diagrams, control charts, and histograms.
  • Be able to articulate, read and follow a SOP (standard operating procedure).
  • Define basic audit types (e.g., internal, external, product, process) and roles (e.g., auditor, auditee, client), and identify basic components of an audit (e.g., audit plan, audit purpose, audit standard) and describe various auditing tools (e.g., checklist, final report).
  • Be able to understand and apply the regulatory requirements of cGMP (current Good Manufacturing Practices) and ISO-13485 certification.
  •  

Technical Standards1 for BTC and BTD

1

For general information about technical standards and accommodation, see Technical Standards.

Students entering this program must be able to demonstrate the ability to:

  • Comprehend textbook material at a college level.
  • Communicate and assimilate information either in spoken, printed, signed, or computer voice format.
  • Gather, analyze, and draw conclusions from data.
  • Stand for a minimum of two hours.
  • Walk for a minimum of six hours, not necessarily consecutively.
  • Stoop, bend, and twist for a minimum of 30 minutes at a time and be able to repeat this activity at frequent intervals.
  • Differentiate colors as assessed by standard color blindness evaluation.
  • Differentiate by touch: hotness/coldness, wetness/dryness, and hardness/softness.
  • Use the small muscle dexterity necessary to do such tasks as gloving, gowning, and operating controls on laboratory instrumentation.
  • Respond to spoken words, monitor signals, and instrument alarms.
  • Identify behaviors that would endanger a person’s life or safety and intervene quickly in a crisis situation with an appropriate solution.
  • Remain calm, rational, decisive, and in control at all times, especially during emergency situations.

Technical Standards for ALQC and BTDQ

Students entering these programs must be able to demonstrate the ability to:

Students entering these programs must be able to demonstrate the ability to:

  • Comprehend textbook material at a college level.
  • Communicate and assimilate information either in spoken, printed, signed, or computer voice format.
  • Gather, analyze, and draw conclusions from data.
  • Stand for a minimum of two hours.
  • Walk for a minimum of six hours, not necessarily consecutively.
  • Stoop, bend, and twist for a minimum of 30 minutes at a time and be able to repeat this activity at frequent intervals.
  • Differentiate by touch: hotness/coldness, wetness/dryness, and hardness/softness.
  • Differentiate colors as assessed by standard color blindness evaluation.
  • Use the small muscle dexterity necessary to do such tasks as gloving, gowning, and operating controls on laboratory instrumentation.
  • Respond promptly to spoken words, monitor signals, and instrument alarms.
  • Identify behaviors that would endanger a person’s life or safety and intervene quickly in a crisis situation with an appropriate solution.
  • Remain calm, rational, decisive, and in control at all times, especially during emergency situations.
  • Manipulate small parts, and make fine hand adjustments to machines and test equipment.
  • Lift 40 pounds.
  • Operate a computer.

AQS Analytical Lab Quality Courses

AQS 110. Introduction to Quality and Metrology. 4 Credits.

This course provides an introduction to the concepts used in STEM disciplines and manufacturing processes to ensure defined procedures are used to deliver results for materials of known and sufficient quality. Prerequisites: ENG 098, FYE 101, MAT 096, RDG 098, (or placement).

AQS 115. Industry Overview and Auditing Principles. 3 Credits.

This course provides an introduction to various industry (both manufacturing and service), international and US regulatory quality system standards. This course will also provide instruction on the audit process and principles. Prerequisites: ENG 098, MAT 096 (or placement). ENG 101 is recommended. Fall.

AQS 200. Conducting Root Cause Investigations. 3 Credits.

This course will provide the student with problem solving skills by exploring the process of conducting an investigation. The quality system tools used to document and facilitate an understanding of the problem and potential solutions will be studied. Prerequisites: ENG 098 (or placement); MAT 162 (or higher). ENG 101 and AQS 110 are recommended.

BTC Biotechnology/Biomanufact Courses

BTC 101. Introduction To Biotechnology (With Application). 4 Credits.

This course is designed to acquaint students with the diverse field of biotechnology. Topics will include a brief history of biotechnology, job opportunities in biotechnology, recombinant DNA and protein products, microbial biotechnology, plant biotechnology, medical biotechnology, DNA fingerprinting and forensic analysis. Current ethical issues such as stem cell research and cloning will also be discussed. Lab sessions will be hands-on experiences revolving around and applying the topics listed in the lab section of the syllabus. Prerequisites: ENG 098, FYE 101, MAT 096 or higher (or corequisite), RDG 098, or placement.

BTC 102. Basic Laboratory Techniques. 3 Credits.

Topics in this course are designed to develop fundamental skills in the set up of typical growth plates and media used in standard culturing of microorganisms or tissue culture as well as preparation of common solutions and reagents. In addition, students will develop fundamental skills in the use, maintenance, and calibration of common laboratory instruments like spectrophotometers and pH meters. Principles of laboratory safety, documentation, and the use of computers in the lab will also be covered. The practical aspect of the course involves preparation of media for numerous biology classes currently offered. Prerequisites: ENG 098, FYE 101, MAT 096 or higher (or corequisite), RDG 098, or placement.

BTC 110. Biotechnology Experience: Concepts And Procedures. 4 Credits.

The first of two experiential, cornerstone courses in biotechnology. The course begins by introducing the student to the role of the technician in biotechnology and GLP (or Good Laboratory Principles). An exploration of the principles of molecular genetics will be provided, including lecture topics in transcription, translation and protein expression in prokaryotes, and eukaryotes. Included in the course will be a hands-on exposure to biotechnology research tools and protocols used for DNA isolation, gene cloning, gene expression and regulation, gene sequencing, and mRNA isolation. Lab sessions will be hands on experiences revolving around and applying the topics listed in the lab section of the syllabus. Prerequisites: BTC 101, BTC 102 with a C or better.

BTC 120. Biotechnology Experience: Biomanufacturing. 4 Credits.

The second of two experiential courses, this course begins by introducing the student to the proteins and companies of biotechnology. In the remainder of the course students use bacteria, mammalian, and yeast cells to produce human proteins using tools and standard manufacturing operating procedures of biotechnology, including upstream and downstream processing of proteins, and quality control of protein production. Lab sessions will be hands-on experiences revolving around and applying the topics listed in the lab section of the syllabus. Prerequisites: BTC 101, BTC 102 with a C or better.

BTC 170. Cell Culture Techniques. 4 Credits.

This lecture/laboratory course will provide students with a solid understanding of basic sterile and aseptic cell culture techniques through the growth and maintenance of both normal and transformed adherent and suspension mammalian cells. Topics include sterile culture techniques, trypsinization and media supplementation, subculturing, cell counting, determining viability and growth curves, cryopreservation, and research applications using cell cultures. Prerequisite: BIO 109; BTC 101 and BTC 102 with a C or better. Spring.

BTC 185. Industrial Microbiology. 4 Credits.

This course covers the principles of various processes associated with the production and recovery of different bioproducts derived from prokaryotes and eukaryotes. Topics include the classification of microorganisms, media development, instrumentation, fermentation principles, mammalian and insect cell propagation, product recovery, protein purification, and the principles of current good manufacturing practices (cGMP). Lab sessions will be hands on experiences revolving around and applying the topics listed in the lab section of the syllabus. Prerequisite: BTC 101 with a C or better OR AQS 110, and BTC 102 with a C or better.

BTC 190. Principles of Protein Purification. 4 Credits.

The biopharmaceutical industry is focused on producing proteins as drugs to treat diseases. This course will investigate the relationship between protein structure and function, present basic methods of protein purification, and demonstrate how protein composition influences the method of purification. The concept of pH and buffers will be discussed in detail in relation to protein purification. Students will be exposed to these concepts in lecture, readings, and the lab. Lab sessions will be hands on experiences revolving around and applying the topics listed in the lab section of the syllabus. Prerequisites: BTC 101, BTC 102 (or co-requisite), CHE 203.

BTC 191. Quality and Compliance. 3 Credits.

Good Manufacturing Practice regulations (cGMPs) apply to pharmaceutical, biotech and medical device products regulated by FDA. This course explores the content and interpretation of the regulations, with emphasis on the necessary practices, procedures and documentation required to achieve full compliance. The course will utilize case studies to facilitate interpretation and application of regulations. All participants will gain a fundamental knowledge of the basis of cGMP regulations, and the necessity of implementing them in daily operations. Additionally, this course is intended to give participants an introduction to the cGMP regulations and their application to laboratory activities, manufacturing processes and support functions, as well as demonstrate the need for thorough and comprehensive GMP training and documentation. The course also provides participants with an understanding of common terminology and the role GMPs play in their day-to-day responsibilities. Consequences of non-compliance will be examined to underline the importance of implementing and maintaining a robust cGMP posture. Prerequisites: BTC 101 with a C or better OR AQS 110 and BTC 102 with a C or better.

BTC 200. Biotechnology Seminar. 3 Credits.

This is a capstone course taken in the last semester before graduation after all of the BTC courses have been successfully completed. This course will provide an in-depth review of the entire process of producing a biologic drug. Students will examine current research being conducted in the biotech industry and explore cGMP regulations through examination of FDA warning letters. As a capstone course, students will be expected to demonstrate mastery and integration of previous BTC major coursework. Prerequisites: BTC 101 and BTC 102 with a C or better; BTC 120, BTC 170(or co-requisite). Spring.