National center for therapeutics manufacturing m.pishko ccp13
1.
2. • Academic Degrees
• Certificate Programs
• Professional Development
• Industry Short Courses
• Workshops
• STEM Outreach Programs
• Internships
PROGRAMS
To provide therapeutics manufacturing
education, training, and outreach programs
to support the development of an educated
and skilled pharmaceutical workforce
proficient in process development,
production systems, standard operating
procedures, and regulatory guidelines.
MISSION
NCTM
3. NCTM EDUCATIONAL FACILITY FEATURES:
NCTM
• Two teaching wet labs accommodating 40 students each
• A cell culture facility
• A 50 work station computer laboratory
• A 3,500 sq. ft. cubicle study/teaming area
• Locker facilities for 100 students
• Two large lecture halls for students & conferences
• A mock cGMP process suite with gowning facilities,
Sartorius and GE bioreactors, and AKTA skids to simulate a commercial environment
The National Center for Therapeutics
Manufacturing (NCTM) is a multi-disciplinary
workforce education and biopharmaceutical
manufacturing center focused on developing
skilled professionals for existing and emerging
biotech and pharmaceutical industries. The
NCTM is located on the Texas A&M University
campus in College Station, Texas.
4. NCTM PROGRAM DEVELOPMENT ACTIVITIES
NCTM
For more information about therapeutics
manufacturing programs and training,
please visit our website at:
http://nctm.tamu.edu/
Texas Workforce
Commission
grant awarded
DECEMBER
Phase I:
Curriculum
assessment
& industry
surveys
All core
curricula
complete
MARCH
Initiated
Internship
Program
FEBRUARY
Phase III:
Curriculum
development
JUNE
Established
program
advisory
board
MAY
MARCH
Phase II:
SME kick-off &
course pre-work
Phase IV:
Course
finalization
& submission
JANUARY
2010 20122011
Began
outreach
activities
OCTOBER
Hosted
inaugural STEM
summer camps
JUNE
Facilities
equipping and
preparedness
FALL
Pilot short
courses to
begin
2013
SPRING
SACS approved
associate
programs
JULY
6. NCTM ACADEMIC PROGRAMS
Undergraduate Certificate in
Therapeutics Manufacturing
Associate of Applied Science (AAS)
Degree in Therapeutics Manufacturing
Advanced Technical Certificate in
Therapeutics Manufacturing
Available now Available now Under development
A 12 credit hour certificate that educates
engineering baccalaureate graduates on how to
economically, ecologically, and safely design
and operate equipment used for the production
and separation of biological materials.
A 69 credit hour degree designed to be completed
in two years. This AAS degree offers enhanced
training in cGMP, quality assurance and control,
and biomanufacturing processes necessary for
pharmaceutical production.
A 21 credit hour certificate which will allow
qualified students with an aligned associate or
bachelor’s degree to pursue a short-track
educational path for immediate employment in
the therapeutics manufacturing environment.
Required Course: Required Courses: Required Courses:
MATH 1314: College Algebra BITC 1411: Introduction to Biotechnology
CHEM1411: General Chemistry I
BITC 1411: Introduction to Biotechnology
Choose One Additional Required Course: BIOL 1406: General Biology I BITC 2371: Facility Operations and Safety
BITC 2371: Facility Operations & Safety
BMEN 282: Engineering Biology BITC 2431: Cell Cultures Techniques
CHEN 382: Bioprocess Engineering BIOL 2421: Microbiology
Choose Two Electives:
CHEN 436: Systems Biology
ISEN 303: Engineering Economical Analysis
Speech Elective
BITC 2374: Drug Product Manufacturing
CHEN 489/BAEN 489: Bioreactor Design BITC 2431: Cell Culture
CHEN 489: Bioprocess Control BITC 2411: Biotech Lab Instrumentation
CHEN 489: Designing for Flexibility BITC 2373: Drug Substance Manufacturing
Social Science Elective
ENGL 1301: Composition & Rhetoric
BITC 2471: cGMP Procedures &
Humanities Elective
BITC 2386: Internship in Therapeutics
Manufacturing
BITC 1371: Introduction to Therapeutics
Manufacturing
BITC 1375: Quality Systems for
Therapeutics Manufacturing
BAEN 302: Biological and Ag Engineering
Fundamentals II
CHEN 489/BAEN 489: Introduction to
Bioseparations
BITC 1371: Introduction to Therapeutics
Manufacturing
BITC 1302: Biotechnology Laboratory
Methods & TechniquesCHEN 471/BAEN 471: Introduction to
Biochemical Engineering BITC 1375: Quality Systems in Therapeutics
Manufacturing
ISEN 360: Lean Thinking/Lean
Manufacturing in Biotechnology
BITC 1191: Special Topics in Therapeutics
Manufacturing
CHEM2470: Introduction to Organic &
Biochemistry
CHEN 489: Safety in Pharmaceutical and
Biotechnology Industries
BITC 2471: cGMP Procedures and
Documentation
NCTM partners with a consortium of
educators, including Texas A&M
University, Blinn College, and the Texas
A&M Engineering Extension Service, to
provide these programs.
Available to students beginning in Fall
2013.
Program provides
>110 contact hours
of technical instruction
NCTM provides a broad spectrum of
educational opportunities, including
contract short courses, certificate and
degree programs.
7. I’m Contagious…
…but I’m developing the cure!
This week-long camp is designed to provide high school students with an introduction to the
pharmaceutical industry. We examine the R&D-to-commercialization pipeline that brings
a medical discovery to the market. Campers have the opportunity to participate in exciting
hands-on laboratory projects, like working with recombinant DNA. They also experience
behind-the-scenes activities at local biotechnology and pharmaceutical companies and some of Texas
A&M’s most elite centers, to learn more about careers in research, engineering, and biomanufacturing.
NCTM STEM SUMMER CAMP
June 4-8, 2012 and June 18-22, 2012
NCTM
9. Subcontracting
Produce Implementation
Schedule
Assign Program Personnel
Identify Specific
Workforce Needs for
CIADM
Q4
Q1
2012 2013
Phase III Complete
Begin Phase IV:
Finalization of
CoursesQ1
Pilot Short Courses on
Existing Curriculum
Begin Phase II:
Curriculum Development
for New TrainingQ2
Phase II Complete
Equipment Purchases
Complete
Begin Phase III:
Curriculum Enhancement
/Expansion
Q3
2014
Distance Learning
Education Development
Workforce Training
Continues
Internship Program
ContinuesQ3
Phase IV Complete
Pilot Training on All
Curriculum (Existing &
New)
Program Maintenance
Q2
Repeat Cycle for
Continual
Improvements
Maintain
Workforce
Readiness Efforts
Q4Initiate Recruitment
Campaign
Expand Advisory Board
Internship Program
Expansion & Piloting
Phase I Complete
Training Needs Assessment for
CIADM Workforce
Begin Phase I: Curriculum
Inventory & Assessment
Purchase Equipment
& Supplies
Assign Instructional Personnel
CIADM WORKFORCE DEVELOPMENT PROGRAM
AUG 2012 – Texas A&M Engineering Experiment Station (TEES) was approved by the Department of
Health and Human Services and awarded a $22.7 million subcontract by the A&M System to lead and
manage the therapeutics manufacturing and advanced development workforce training programs for
the Texas A&M Center for Innovation in Advanced Development and Manufacturing.
Q4