medicine leaf
pointing to tube
man with bioreactor
157_9_GLP6_Hood_2-1
BIOSC 157/9: Foundations In Biotechnology

Good Laboratory Practice ( lab notebook, technical skill, improving SOP's)

186_1_BIoreactor_JavierBioreact
BIOSC 186 : Protein Purification and Analysis

Bioreactor use (grow and sample cells in carefully controlled aseptic conditions)

1_diagnostic_dreamstime_xxl_204427424
BIOSC 182 GLP and cGMP, Principles and Compliance

What are the penalties for failing? (right to operate, warning letters, recall)

157_2_MeasuringCintiaRJGerald
BIOSC 157/9: Foundations in Biotechnology

Precision measuring devices (micropipettes, analytic balance, spectrophotometry)

186_2_Column_BijonJacobSyrings
BIOSC 186 : Protein Purification and Analysis

Column chromatography (ACTA-FPLC, size exclusion, ion-exhange)

2_pharmaceutical_dreamstime_xxl_9966528
BIOSC 182 GLP and cGMP, Principles and Compliance

What is regulated (cannabis, pharmaceutical, diagnostic testing, GMO's)

157_3_LabCalcGeraldDeangelaHappyNotebookPlant-1
BIOSC 157/9 Foundations in Biotechnology

Lab calculations (dilutions, standard curves, solution recipes)

186_3_IsolationKatie_Javier
BIOSC 186 : Protein Purification and Analysis

Protein isolation (extraction technique, separation, storage, labeling)

3_cannabis_dreamstime_xxl_169891901
BIOSC 182 GLP and cGMP, Principles and Compliance

Changes to regulations? (legislation, advocacy, critical thinking)

157_4_AsepticGroupWeighSoil-1
BIOSC 157/9 Foundations in Biotechnology

Aseptic technique (biosafety cabinets, media, avoid sample contamination)

186_4_BiologicalELISA_PLate
BIOSC186 : Protein Purification and Analysis

Biological assays (HPLC, FPLC to detect contaminants and impurities)

4_authorities_dreamstime_xxl_181708099
BIOSC 182 GLP and cGMP, Principles and Compliance

Who are the authorities? (FDA, CA Dept of Cannabis control, USDA, EPA, DEA)

157_5_GMPTissueCultureGroup-1
BIOSC 157/9 Foundations in Biotechnology

cGMP (following SOP's, batch recrods, validation)

186_5_ScaleUpJavier_JacobSample
BIOSC 186 : Protein Purification and Analysis

Scale up (test multiple growth conditions, select most productive)

5_medicalcann_dreamstime_xxl_78474235
BIOSC 182 GLP and cGMP, Principles and Compliance

Why do the regulations exist? (history of legislation, enforcement, societal effects)

157_6_LoadGel
BIOSC 157/9 Foundations in Biotechnology

Bioseparations (HPLC, FPLC, agarose gel, centrifiguation)

186_6_Analysisglowtubes1
BIOSC 186 : Protein Purification and Analysis

Analysis of purity data (prepare certificate of analysis, active ingredient, contaminant/impurity levels)

6_rules_dreamstime_xxl_15151948
BIOSC 182 GLP and cGMP, Principles and Compliance

What are the rules? (cGMP, SOP's, Certificate of analysis, documentation)

157_7_Datainterp_ComputerShare1-1
BIOSC 157/9 Foundations in Biotechnology

Data interpretation and analysis (excel, statistics, graphing)

186_7_CalculateAlbert_DeAngela_Jacob
BIOSC 186 : Protein Purification and Analysis

Calculate yield (efficiency of process, continuous improvement)

7_comply_dreamstime_xxl_208818777
BIOSC 182 GLP and cGMP, Principles and Compliance

How do we comply? (licensing, training, equipment, procedures, cGMP)

157_8_LabsolnPourPlates1
BIOSC 157/9 Foundations in Biotechnology

Laboratory solutions (growth media, extraction buffers, assays)

186_8_SolutionGradCyllinder
BIOSC 186 : Protein Purification and Analysis

Solution prepration (calculations, precision measurment, sterilization)

8_compliance
BIOSC 182 : GLP and cGMP, Principles and Compliance

How is compliance and safety checked? (audits, applications, documentation, facilities)

157_2_PrecisionEricScale
BIOSC 157/9 Foundations in Biotechnology

Precision measuring devices (micropipettes, analytic balance, spectrophotometry)

186_9_GMP7_Hood_Team_Prep_IMG_8164
BIOSC 186 : Protein Purification and Analysis

cGMP, GLP (batch records, sampling, documentation, acurate technique)

9_safe_dreamstime_xxl_210282170
BIOSC 182 GLP and cGMP, Principles and Compliance

How do I know my medicine is safe? (Biopharmaceutical, Cannabis)

157_10_MicroGabyMicroscope-1
BIOSC 157/9 Foundations in Biotechnology

Microscopy (sample preparation, staining, analysis)

186_10_PrecisionMultiChannelHoodTwo2
BIOSC 186: Protein Purification and Analysis

Precision measuring devices (micropipettes, spectrophotometry, analytical balance)

10_new_dreamstime_xxl_164840097
BIOSC 182 GLP and cGMP, Principles and Compliance

How is a new drug approved? (Canabis, pharmaceutical, etc.)

157_1_DNATechRayAshleyPoint-1
BIOSC 157/9 Foundations in Biotechnology

DNA technology (PCR, extraction, Next generation sequencing)

186_Main_BijonBioreact
BIOSC 186 : Protein Purification and Analysis
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The Biotechnology Technician Certificate of Achievement provides classroom and hands-on laboratory training needed for entry-level employment in the areas of manufacturing, quality control, quality assurance, and research and development in the biotechnology industry. Workplace skills, understanding of industry requirements for employees, and work-based experience are emphasized.

This program trains and educates students for thoughtful, productive work in research laboratories and industrial situations. Upon completion of a certificate or degree, students will be able to: maintain a safe and productive work environment, manage and communicate information, perform mathematical manipulations, perform measurements/tests/assays, prepare solutions and media, and comply with applicable regulations and standards.

Course Requirements (6 total)

Core Biotechnology Course #1

Core Biotechnology Coure #2

  • BIOSC157/9 – Foundations in biotechnology lecture and lab (3U)

Advanced Lab course #1 (choose 1)

  • BIOSC186 : Protein Purification and Analysis (Purification and analysis of biological molecules)
  • BIOSC188 : Biotechnology Operations
  • BIOSC183 : Eukaryotic (Mammalian) Cell Culture
  • BIOSC182 : GLP and cGMP, Principles and Compliance (Safety and efficacy of regulated products)
  • BIOSC147 : Molecular and Cellular Biology

Advanced Lab course #2 (choose 1)

  • BIOSC186 : Protein Purification and Analysis (Purification and analysis of biological molecules)
  • BIOSC188 : Biotechnology Operations
  • BIOSC183 : Eukaryotic (Mammalian) Cell Culture
  • BIOSC182 : GLP and cGMP, Principles and Compliance (Safety and efficacy of regulated products)
  • BIOSC147 : Molecular and Cellular Biology

Business and Communication (choose 1)

  • BUS 120 : Introduction to Management
  • SPCH 120 : Public Speaking

Computer and data proficiency (choose 1)

  • MATH164 : Introduction to Probability and Statistics
  • CIS135 : Introduction to Computers
  • BOT224 : Microsoft Excel for Business
  • BOT226 : Microsoft Access for Business

Competencies

  • Graduates are able to follow procedures, correctly use typical laboratory equipment and glassware, are meticulous about labeling. They have extensive training and practice in the correct use of laboratory notebooks for documenting all activities, data, and analysis.
  • Graduates communicate effectively, both in writing and in conversation, and are skilled at working in teams. Some have excellent presentation skills.
  • Graduates have strong math skills. All are able to use typical laboratory calculations (eg. unit conversion, ratios, dilutions with multiple solutes, graphing) to plan and analyze experiments. Some have extensive statistics training.
  • Graduates can provide routine facility support including: Media and other Solutions prepared correctly, Demonstrate correct usage of precision measuring devices
  • Graduates can identify key validation concepts including equipment, process, computer, analytical and cleaning validation

Skills in

  • Scientific Communication of biology and life science
  • Aligning biotechnology products to basic biology concepts
  • Navigate biotechnology company structure and innovation culture
  • Polymerase chain reaction
  • Bioassays
  • Maintaining detailed lab records
  • Good documentation practices
  • Standard Operating Procedures
  • cGMP (Good Manufacturing Practice)
  • Cell culture in bioreactors
  • Chromatography for purification and analysis
  • Quantitative analysis of purified molecules
  • and more!

Knowledge of

  • Biological structures and molecules (Cells, genes, DNA, Protein…)
  • Regulations affecting the biotechnology field
  • Cell culture, including stem cells
  • Lab processes and procedures
  • cGMP and GLP
  • Batch records
  • Importance of following established procedures
  • Inspections & Audits
  • Quality Assurance and Quality Control
  • Laboratory calculations for media and assays
  • Scale up
  • cGMP, GLP
  • and more!

Ability to

  • Explain common life science techniques (PCR, chromatography, sequencing)
  • Discuss legal and ethical issues surrounding biotechnology
  • Explain process of bio-product development and manufacturing
  • Method development
  • Follow SOP’s
  • Accurate data collection
  • Comply with regulations and oversight in biological manufacturing
  • Product development and commercialization with cGMP and GLP
  • Validation: Equipment, Process, Computer, Analytical, Cleaning
  • Analyze purification data (yield, purity)
  • Batch Records
  • Develop purification strategies based on molecule characteristics
  • and more!

What type of jobs does this prepare for?

  • Biological manufacturing Technician
  • Laboratory Technician
  • QA/QC Analyst/Technician/Associate
  • Research Associate (with Bachelor’s degree)

Student Learning Outcomes

  • Comply with applicable Regulations and Standards, including good documentation and labeling
  • Perform Mathematical manipulations, including accurate preparation solutions and dilutions
  • Maintain a safe and productive work environment
  • Perform measurements, tests or assays and present data in an appropriate manner

For the official Biotechnology Technician Certificate of Achievement Program Outline of Record (POR) click here.