BioNetwork Training

The BioNetwork Capstone Center provides affordable, high-quality, hands-on training in biotechnology, biomanufacturing, and biopharmaceutical/pharmaceutical operations in a simulated industrial (cGMP) environment.

The Capstone Center is situated in the Golden LEAF Biomanufacturing Training and Education Center (BTEC) at North Carolina State University Centennial Campus. It provides a training environment that mirrors a biomanufacturing plant facility with state-of-the-art classrooms, industrial-grade equipment laboratories, and a certified cleanroom suite.

Industry-recognized credential: BioNetwork Capstone Certificates

Complete in: 12 months or less

For non-credit student support services or to see if you qualify for financial assistance, contact the Career Pathways Program & Student Resources. 

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BioNetwork Certificate Programs

BioNetwork Certificate in Pharmaceutical Processing Basics

Certificate Name:

BioNetwork Certificate in Pharmaceutical Processing Basics

Course Description:

The following Pharmaceutical Processing skill sets are fundamental and applicable to all phases of regulated pharmaceutical production. They are recommended as baseline and the necessary foundation to derive the most knowledge and understanding from the other listed BioNetwork Capstone Certificates.  This Certificate’s content is applicable to learners new to the industry or seeking to enter the industry at an entry level technical or professional position.

 

This is our foundational biomanufacturing certificate and is prerequisite for all other certificates in this area. Waivers for prior learning or experience are considered on a case by case basis for courses in this certificate series only.

Requirements:

  • Elements of Current Good Manufacturing (cGMP) Practices
  • Good Documentation Practices and Record Keeping Requirements
  • Deviations, Investigations, and CAPA
  • Fundamentals of Validation
  • Basic Microbiological Laboratory Skills

BioNetwork Certificate in Biomanufacturing

Certificate Name:

BioNetwork Certificate in Biomanufacturing

Course Description:

The biomanufacturing skill sets are important to the understanding of the production of cell-based products. Certificate content is applicable to learners engaged, or interested in positions in process, quality assurance, validation, and/or engineering.

Requirements:

  • BioNetwork Certificate in Pharmaceutical Processing Basics
  • Operations in Biotechnology Processes: An Overview
  • Fundamentals of Biomolecules
  • Fermentation Processes
  • Cell Culture Processes
  • Chromatography in Theory and Practice

BioNetwork Certificate in Aseptic Processing

Certificate Name:

BioNetwork Certificate in Aseptic Processing

Course Description:

The biomanufacturing skill sets are important to the understanding of the techniques and controls necessary to processing sterile products in an aseptic environment.  Certificate content is applicable to learners engaged or interested in aseptic processing, environmental monitoring and quality assurance of aseptic processing activities.

Requirements:

  • BioNetwork Certificate in Pharmaceutical Processing Basics
  • Fundamentals of Biomolecules
  • Aseptic Processing I
  • Aseptic Processing II
  • Fundamentals of Microbiology

BioNetwork Certificate in Analytical Chemistry Laboratory Skills

Certificate Name:

BioNetwork Certificate in Analytical Chemistry Laboratory Skills

Course Description:

The analytical chemistry laboratory skill sets are important to fundamental controls, techniques and instrument applications used in a pharmaceutical analytical chemistry laboratory. Certificate content is applicable for learners engaged or interested in pharmaceutical analysis and the quality assurance of analytical results.

Requirements:

  • BioNetwork Certificate in Pharmaceutical Processing Basics
  • Fundamentals of  Biomolecules
  • Micropipetting Techniques for Precision and Accuracy
  • Basic Analytical Laboratory Skills
  • Analytical Method Validation
  • HPLC in Theory and Practice

BioNetwork Certificate in Microbiological Laboratory Skills

Certificate Name:

BioNetwork Certificate in Microbiological Laboratory Skills

Course Description:

The microbiological laboratory skill sets are important to fundamental controls, techniques and instrument applications used in a pharmaceutical microbiology laboratory. Certificate content is applicable for learners engaged or interested in microbiological assessments and identifications and the quality assurance approval of microbiological results.

Requirements:

  • BioNetwork Certificate in Pharmaceutical Processing Basics
  • Micropipetting Techniques for Precision and Accuracy
  • Basic Microbiological Laboratory Skills
  • Fundamentals of Microbiology
  • Advanced Microbiological Methods

BioNetwork Certificate for Calibration and Maintenance for Controlled Environments

Certificate Name:

BioNetwork Certificate for Calibration and Maintenance for Controlled Environments

Course Description:

The calibration and maintenance skill sets are important to fundamental controls, and maintenance techniques used for pharmaceutical utility system and equipment preventive and return-to-service maintenance activities. Certificate content is applicable for learners engaged or interested in pharmaceutical maintenance and calibration services as well as the quality assurance of those activities.

Requirements:

  • BioNetwork Certificate in Pharmaceutical Processing Basics
  • Operations in Biotechnology Processes: An Overview
  • Maintenance Controls for Aseptic Operations
  • Instrumentation Calibration Program for Life Sciences
  • Fundamentals of Utility Systems

BioNetwork Certificate in Validation

Certificate Name:

BioNetwork Certificate in Validation

Course Description:

These validation skill sets are important to fundamental elements, techniques and regulatory expectation used in pharmaceutical equipment/systems qualification and process validations.  Certificate content is applicable for learners engaged or interested in qualification/validation protocol creation, execution, review, and quality assurance approval.

Requirements:

  • BioNetwork Certificate in Pharmaceutical Processing Basics
  • Validation Documentation
  • Introduction to Computer Validation
  • RiskBased Approaches to Validation
  • Computer Applications Validation


Course Details & Registration Information

Course
Preparation and Purification of Biological Samples for HPLC Analysis
Name
SEF-79824
Available Classes
    Section Location Begin Date End Date Instructor Price Seats Available/Total Seats
180899 BTEC BioNetwork Capstone Learning Center 10/28/2017 11/18/2017 G. Picard $252.00 7/12
Description Course Outline Requirements Intended Audience More Details
Description
Gain hands-on laboratory experience in sample preparation and purification techniques used in High Performance Liquid Chromatography (HPLC) analysis of biological samples for trace levels of drug and pesticide residues. Participants will prepare chromatography standards and reagents, perform sample extractions, complete purification procedures (liquid-liquid partitioning and solid-phase extraction), calibrate an HPLC system using both manual injection and automatic injection systems, and follow HPLC methods.
Course Objectives
  1. Understand the process for preparing a biological sample for HPLC analysis, including extraction and purification techniques
  2. Gain hands-on experience performing sample preparation and purification techniques
  3. Gain theoretical understanding and practical experience in the operation of HPLC instrumentation
Outline of Instruction
  1. Introduction to bio-analytical (trace organic) analysis
  2. Sampling techniques
  3. Sample extraction techniques
  4. Sample extract purification, including solid-phase extraction and solvent partitioning techniques
  5. The basics of High Performance Liquid Chromatography (HPLC)
  6. Instrumentation videos
  7. Lab – Standard solution preparation
    a. Preparation of a stock analytical standard solution
    b. Preparation of calibration and fortification standard solutions from the stock analytical standard solution using serial dilution technique
  8. Calibration of an HPLC unit
  9. Lab – Standard curves and reagent preparation
    a. Preparation of reagent solutions for Methods M 001, M 002, and M 003
    b. HPLC manual injection technique and generation of calibration data
    c. Generating HPLC standard curves from the manual injection standard calibration data
  10. The importance of lab controls and lab fortified controls as quality control checks
  11. Method M 001- Determination of a trace-level organic contaminant in water
    a. Overview and discussion
    a. Instructor demonstration of Method M 001
    b. Lab - student performance of Method M 001
  12. Method M 002 - Determination of a trace-level organic contaminant in milk
    a. Overview and discussion
    b. Instructor demonstration of Method M 002
    b. FDA validation criteria for a bio-analytical method
    c. Lab - Student performance of Method M 002
  13. Lab - HPLC mobile phase effects on chromatographic separations
    a. Mobile phase preparation
    b. Evaluation of mobile phase flow rate and composition on component retention times
  14. Lab - HPLC auto injection
    a. Prepare HPLC for auto-injection of calibration standards for an overnight run
    b. Generating HPLC standard curves using automatic injector data calibration data
  15. Challenges posed by real world samples
  16. Method M 003 - Determination of a trace-level organic contaminant in dry animal feed.
    a. Instructor demonstration of Method M 003
    b. Student performance of Method M 003
  17. Review and course exam
Contact Hours
32
CEU's
3.2
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
High school diploma, successful completion of BioWork program, or equivalent education.
Text and Supplies Needed
Clinical Site/Special Facilities
1. HPLC equipped with a UV detector and both manual and automatic injection systems
2. Waters Symmetry Reverse Phase Column
3. Solid Phase Extraction cartridges and manifolds
4. Analytical balance
5. Top loading balance
6. pH meter
7. Vacuum pump
8. High speed refrigerated centrifuge
9. Laboratory shaker
10. Reagents: methanol, acetonitrile, methylene chloride, Milli-Q water, sodium chloride, potassium chloride, 5N hydrochloric acid, and acetic acid
11. Milk and bunny food
12. Assorted lab glassware and pipettes
13. Imazaquin standard
Requirements for Successful Completion of this Course
  1. Attendance 90% or above
  2. Participation
  3. Achieve a minimum score of 70% on course exam.
Accreditation/Special Approval Requirements
Intended Audience
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
Related Courses
  • Sample Preparation for HPLC Analysis - SEF-178CL
  • HPLC in Theory and Practice - SEF-79624
  • Chromatography in Theory and Practice - SEF-79614
Course Contact Information
Willie Green-Aldridge
919-515-0232