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
previous arrowprevious arrow
next arrownext arrow
Shadow