List Of SOPs

1.Purpose:

To concentrate and perform buffer exchange of protein products using tangential flow and diafiltration processes

2.Scope and Applicability:

Applies to performing Tangential Flow Filtration with the Millipore Pellicon XL Device to concentrate and perform buffer exchange.

3.Summary of Method:

Preparation of solutions
Install resonate and permeate tubing and tank outlet valve on the Labscale 500ml Reservoir and add the stir bar
Connect the Labscale 500 ml Stir Base to power and check operation
Install the Pellicon XL Device
Flush and precondition the Labscale Tangential Flow Filtration System
Concentrate the sample, perform a buffer exchange on the sample, and then retrieve the sample.
Flush, clean, and drain the system.
Flush and prepare the Pellicon XL Device for storage.
Clean the Labscale Tangential Flow Filtration System.

4.References:

pH meter SOP

5.Definitions:

Permeate- the material that passes through the membrane.
Retentate- the material that does not pass through the membrane.

6.Precautions:

0.1N NaOH is very corrosive. It is extremely damaging to eyes and mucous membranes. It causes burns. Avoid contact with skin. It is harmful if swallowed or inhaled. The Millipore Pellicon XL Device is stored flat at 4-25°C with 10ml of 0.1N NaOH.
NEVER tighten the clamp enough to completely restrict the flow in the Retentate tube. This could damage the filter and cause the tubing to disconnect.

7.Responsibilities:

It is the responsibility of the course instructor/lab assistant to ensure that this SOP is performed as described and to update the procedure when necessary.
It is the responsibility of the students/technician to follow the SOP as described and to inform the instructor about any deviations or problems that may occur while performing the procedure.

8.Equipment and Materials:

0.1N NaOH (sodium hydroxide)
0.05N NaOH (sodium hydroxide)
NaH2PO4 (sodium phosphate monobasic, anhydrous)
Na2HPO4-7H2O (sodium phosphate dibasic, heptahydrate)
preconditioning buffer
pH Meter and pH paper
2 L filter unit
2 magnetic stir plate and stir bars
Millipore Tangential Flow Filtration System and Pellicon XL Device and Accessories
3 containers, 500mL
50 mL graduated cylinder
MilliQ Water
2L graduated cylinder
2L Flask
10ml graduated cylinder
25 ml beaker

9.Procedure:

9.1.Preparation and Set Up

Prepare 0.1N NaOH for cleaning.
1. Using a 1L graduated cylinder, measure 1L of MilliQ water.
2. Transfer water to a 1L flask.
3. Weigh 4.0±0.05g of NaOH.
4. Transfer NaOH to flask.
5. Add magnetic stir bar and stir to dissolve.
6. Sterile filter the solution and label container: 0.1N NaOH, [date], [initials], [group number], Storage: room temp, Disposal: adjust to pH 7 then drain.
Prepare 0.05N NaOH for Pellicon XL Device Storage
1. Using a 10 ml graduated cylinder, measure 5 ml of MilliQ water
2. Transfer MilliQ water to 25 ml beaker
3. Using a 10 ml graduated cylinder, measure 5 ml of 0.1N NaOH
4. Transfer 5 ml of 0.1N NaOH to 25 ml beaker
5. Add magnetic stir bar and stir to dissolve.
6. Sterile filter the solution and label container: 0.05N NaOH, [date], [initials], [group number], Storage: room temp
Diafiltration Buffer Preparation (20mM Phosphate Buffer pH 7.1)
1. Weigh out 0.80±0.02g NaH2PO4 and place into 1L flask
2. Weigh out 3.60±0.2g Na2HPO4-7H2O and place into the 1L flask containing NaH2PO4.
3. Using a 1L graduated cylinder, measure 1L of MilliQ water.
4. Add the water to the 1L flask containing the phosphates.
5. Add a magnetic stir bar and stir to dissolve.
6. Adjust pH to 7.1±0.1.

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1.Purpose:

To verify the calibration of a single channel pipette

2. Scope:

Covers the cleaning, decontamination and verification of a single channel pipette

3.Responsibilities:

It is the responsibility of the course instructor/lab assistant to ensure that this SOP is performed as directed and to update the procedure when necessary.
It is the responsibility of the students/technicians to follow the SOP as described and to inform the instructor about any deviations or problems that may occur while performing the procedure.

4.References:

balance operation SOP
balance calibration SOP
Tuttnauer 3850 ELV Autoclave SOP
Eppendorf Research Plus Operation and Maintenance SOP

5.Definitions: N/A

6.Precautions: N/A

7.Materials:

balance
weigh boats
MilliQ water
small beaker for holding MilliQ water
verification labels
verification form
verification Pass/Fail form
pipette tips
Eppendorf Research Plus (P20, P200, and P1000)
70% isopropyl alcohol (IPA)
lab towels
tweezers
thermometer
calculator
barometer

8.Procedure:

Clean the pipette (See Figure 2.)

Note: Most pipettes are designed so that the parts that normally come into contact with liquid contaminants can easily be cleaned and decontaminated.

Wipe entire pipette with a lab towel dampened with a mild detergent solution.
Wipe entire pipette with a lab towel dampened with distilled water.
Remove the ejector sleeve by holding down the ejection button and pulling on the ejector sleeve (Figure 2: Step 1).
Slide up the ring on the lower part with the label “PUSH TO RELEASE” approximately 5mm until the lower part is released (Figure 2: Step 2 & 3).
The lower part is then removed from the upper part (Figure 2: Step 4).
Wipe the ejector sleeve and lower part with a lab towel dampened with a mild soap solution or 70% IPA.
Wipe the ejector sleeve and lower part with a lab towel dampened with MilliQ water.

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1.Purpose:

The operation of the YSI 2900 Biochemistry Analyzer to measure the glucose and lactateconcentrations in samples.The YSI 2900 Analyzer utilizes enzyme sensor technology to measure concentrations of up to two analytes in solution. Using this technology, enzymes are immobilized in a 3-layer membrane on platinum probes in the instrument. When samples containing glucose or lactate are injected on to the membranes, they are oxidized to hydrogen peroxide (H2O2). Hydrogen peroxide (H2O2) is then oxidized at the platinum probe and produces a probe current. The probe current at each probe is proportional to the amount of hydrogen peroxide and therefore to the amount of glucose or lactate in the sample. This SOP describes the use of the YSI 2900 to measure glucose and lactose concentration in samples.

2.Scope:

This SOP applies to operation of the YSI 2900 Biochemistry Analyzer to measure the glucose and lactate concentrations in samples.

3.Responsibilities:

It is the responsibility of the course instructor/lab assistant to ensure that this SOP is performed as described and to update the procedure when necessary.
It is the responsibility of the students/technicians to follow the SOP as described and to inform the instructor about any deviations or problems that may occur while performing the procedure.

4.References:

4.1 YSI 2900 Operations Manual

5.Definitions:

Not Applicable

6.Precautions:

Wear personal protection equipment when operating the instrument and handling samples.

7.Materials:

YSI Buffer Kit ( YSI # 2357)
YSI Glucose Membrane Kit ( YSI # 2365)
YSI Lactate Membrane Kit (YSI # 2329)
YSI Glucose-/Lactate Standard (YSI # 2747- glucose 1.80 g/L, L-lactate-0.45 g/L)

8.Procedure:

Prime the instrument fluid system

From the configure screen, touch the “initialize” tab
Touch the “prime” button under bottle B1 to prime the buffer solution
Touch the “prime” button under Bottle C1 to prime the calibrator bottle
Check Probe Current
1. From the “initialize” tab of the Configure screen, touch either “flush” button to flush the sample chamber with buffer
2. Observe the probe current values. They must be below 6 nA and stable. When the enzyme probe baseline currents are below 6 nA and stable, the probe indicators change from red to green. Once both probe indicators are green, touch the “X” button at the top left of the screen to exit the main display

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1.Purpose:

The isolation/purification of anti IL-8 monoclonal antibodies, (IgG) from CHO DP12 conditioned media using gravity flow protein A chromatography.

2.Scope:

This SOP can be used to isolate anti-IL8 antibodies in CHO DP12 conditioned media for further analysis.

3.Summary of Method:

Anti-IL-8 monoclonal antibody is purified by affinity chromatography using a protein A-agarose column run on gravity flow. The protein A column is equilibrated and anti-IL-8 mAb-containing conditioned media is loaded onto the column. The column is washed, then eluted using a low pH buffer. Antibody containing fractions are collected and the column resin regenerated for further use.

4.Responsibilities:

It is the responsibility of the Analyst to ensure that this SOP is performed as described and to update the procedure when necessary.
It is the responsibility of the technician to follow the SOP as described and to inform the instructor about any deviations or problems that may occur while performing the procedure.

5.References:

SOP: Spinner Flask Culture for the Production of Anti IL-8 Monoclonal Antibody
SOP: Spinner Flask Harvest
Protein A IgG Purification Kit, User Guide, Thermo Scientific,
Tech Tip #7: Remove air bubbles from columns, Thermo Scientific, Thermo Fisher.com

6.Precautions:

Routine care should be exercised in the handling of buffers and samples of biological materials, which may have harmful biological activity in the case of accidental ingestion, needle stick etc.
Gloves, a lab coat and protective eyewear should be worn when handling buffers and samples.
The columns are stored in a solution of 0.02% sodium azide. Sodium azide is highly toxic through skin contact, inhalation and ingestion. Always wear gloves, safety goggles and a lab coat when handling sodium azide. Sodium azide solutions should never be disposed of by pouring down a drain.

7.Materials:

Protein A IgG Purification Kit, Thermo Scientific Catalog # 44667
50 ml of Neutralization Buffer, 1M Tris, pH 9
0.02% Sodium Azide in water solution for column storage
Sterile Filtered Milli Q water
10 ml microfiltered CHO DP12 Conditioned Media, from a culture with a cell density of approximately 1x10⁶ cells/ml
A ring stand and clamp to support the column
2 ml microfuge tubes and rack
2 – 15 ml conical tubes
P1000 pipettor and tips or transfer pipettes.
0.2µm syringe filter and syringe
Spectrophotometer for measuring Absorbances at 280nm
pH meter

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1.Purpose:

To detect Human Serum Albumin (HSA) via Enzyme Linked Immunosorbent Assay (ELISA) and quantify the concentration of HSA in each sample.

2.Scope:

To detect and quantify the Human Serum Albumin concentration of a given sample using the Human Albumin ELISA.

3.Responsibilities:

It is the responsibility of the course Supervisor to ensure that this SOP is performed as described and to update the procedure when necessary.
It is the responsibility of the analytical technicians to follow the SOP as described and to inform the instructor about any deviations or problems that may occur while performing the procedure.

4.References:

Human Albumin ELISA Quantitation Set manual
plate reader SOP

5.Definitions: N/A

6.Precautions:

Albumin standards are of human origin and should be treated as Biosafety Level 2. Dispose of waste in biohazard containers.
Do not expose TMB Substrate solution to glass, foil or metal. Do not use if solution is blue.

7.Materials:

Human Albumin ELISA Quantitative set from Bethyl Laboratories (cat #: E80-129)
1. ELISA Coating buffer (cat# E107)
2. ELISA Wash solution (cat# E106)
3. ELISA Blocking buffer (cat# 104)
4. Sample/ Conjugate Diluent (ELISA Blocking Buffer + Tween 20)

7.1.5. 10% Tween 20 (cat#E108)

Enzyme substrate , TMB (cat# E102)
96 well plates
Human Albumin Standards
micropipettors (P-100 or P-200) and tips
biopure water
paper towels
containers to prepare buffers
containers to prepare reagents
microfuge tubes
micro titer plate reader operable at 450 nm
0.18M H₂SO₄ (sulfuric acid)

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1.Purpose

To perform tangential flow filtration

2.Scope:

Applies to performing Tangential Flow Filtration with the Millipore Pellicon XL Tangential Apparatus to concentrate and perform buffer exchange

3.Responsibilities:

It is the responsibility of the course Supervisor to ensure that this SOP is performed as described and to update the procedure when necessary.
It is the responsibility of the analysts to follow the SOP as described and to inform the instructor about any deviations or problems that may occur while performing the procedure.

4.References:

Millipore Pellicon XL Operations Manual
pH meter SOP

5.Definitions:

Permeate- the material that passes through the membrane.
Retentate- the material that does not pass through the membrane.

6.Precautions:

0.1M NaOH is very corrosive. It is extremely damaging to eyes and mucous membranes. It causes burns. Avoid contact with skin. It is harmful if swallowed or inhaled. The Millipore Pellicon XL Tangential Apparatus is stored and flushed with 0.1M NaOH.
NEVER tighten the clamp enough to completely restrict the flow in the Retentate tube. This could damage the filter and cause the tubing to disconnect.

7.Materials:

0.1M NaOH (sodium hydroxide)
preconditioning buffer
pH Meter and pH paper
1L filter unit
magnetic stir plate and stir bars
Millipore Pellicon XL Tangential Apparatus
peristaltic pump
two pieces of ~40 cm long tubing
1 Masterflex ~60 cm long thick wall tubing. (Masterflex 96400).
3 fittings and 1 clamp
3 containers, 500mL
50 mL graduated cylinder
3 cable ties
biopure water

1.Purpose:

Use of the Glucose Determination Assay.

2.Scope:

Applies to the quantitative determination of Glucose in Conditioned Media

3.Responsibilities:

It is the responsibility of the Supervisor to ensure that this SOP is performed as described and to update the procedure when necessary.
It is the responsibility of the Analyst to follow the SOP as described and to inform the instructor about any deviations or problems that may occur while performing the procedure.

4.References:

https://medtestdx.com/product/pointe-glucose-oxidase-open-channel-reagent/

5.Precautions:

The reagent should not be used if it has developed turbidity or other signs of microbial growth.
The reagent should not be used if it fails to meet linearity claims or fails to recover control values in the stated range.

6.Materials:

P-20 and P-1000 micropipette and tips
Micro centrifuge tubes
Timer
Spectrophotometer able to read at 500nm
Cuvettes
Water bath (37°)
Pointe Scientific Glucose(oxidase) Liquid reagent Catalog# G7521-120
Pointe Scientific General Chemistry Standards Catalog# G7518STD
Pointe Scientific General Chemistry Control Level II Catalog# C759150

7.Procedure:

Running Assay
1. Turn on water bath and set to 37°C.
2. Label micro centrifuge tubes “Blank,” Control,” Standard,” “Sample Name #’s.”
3. Pipette 1.0ml of working reagent to all of the tubes and place in the 37°C water bath for 5 minutes.
4. Remove micro centrifuge tubes from the water bath.
5. Add 10µl of control solution to the “Control” tube, 10µl of Glucose standard to the “Standard” tube, and 10µl of sample to each of their respective “Sample” micro centrifuge tubes and mix by gently aspirating and dispensing the solution with the micropipette.
6. Place all of the micro centrifuge tubes except for the “Blank” micro centrifuge tube back into the 37°C water bath for 10 minutes.
7. Remove the micro centrifuge tubes from the 37°C water bath and immediately remove 1ml from each microfuge tube and place it in a corresponding labeled cuvette.

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1.Purpose:

To perform the Lactate Determination Assay by using spectrophotometry test.

2.Scope:

Applies to the quantitative determination of Lactate in Conditioned Media.

3.Responsibilities:

It is the responsibility of the Supervisor to ensure that this SOP is performed as described and to update the procedure when necessary.
It is the responsibility of the analyst to follow the SOP as described and to inform the instructor about any deviations or problems that may occur while performing the procedure.

4.References:

https://medtestdx.com/product/pointe-lactate-open-channel-reagent/

5.Precautions:

Reagents contain sodium azide as preservative. Upon disposal flush with large volumes of water.
Do not use the reagents beyond the expiration date printed on the label.

6.Materials:

P-20 and P-1000 micropipette and tips
Micro centrifuge tubes
Timer
Spectrophotometer able to read at 550nm
Cuvettes
Heating block (37°)
Pointe Scientific Lactate Liquid Reagents Catalog# L759650
Pointe Scientific Chemistry Lactate Standard Catalog# L7596STD
Pointe Scientific General Chemistry Control Level II Catalog# C759150
Normal Saline (0.9% NaCl) 50 ml to dilute the samples

7.Procedure:

Running Assay
1. Turn on heating block and set to 37°C.
2. Label micro centrifuge tubes “Blank,” Control,” Standard,” “Sample Name #’s.”
3. Prepare Lactate working reagent by combining R1 and R2 using a 3 to 2 ratio. Ex: Mix 3ml of R1 reagent with 2ml of R2 reagent.
4. Pipette 1.0ml of working reagent to all of the tubes and place in the 37°C heating block for 5 minutes.
5. Remove micro centrifuge tubes from the heating block.
6. Add 10µl of control solution to the “Control” tube, 10µl of Lactate standard to the “Standard” tube, and 10µl of sample to each of their respective “Sample” micro centrifuge tubes and mix by gently aspirating and dispensing the solution with the micropipette.
7. Place all of the micro centrifuge tubes except for the “Blank” micro centrifuge tube back into the 37°C heating block for 5 minutes.
8. Remove the micro centrifuge tubes from the 37°C heating block and immediately remove 1ml from each microfuge tube and place it in a corresponding labeled cuvette.
9. Read and record the absorbance of the tubes at 550nm using the “Blank” tube to zero the spectrophotometer.
10. Record absorbance values for each of the tubes and calculate the concentration of Lactate.

7.2.Calculate Lactate Concentration.

Formula to determine lactate concentration:

Lactate (mmol/L) = Abs of sample x Concentration of standard (mmol/L) Abs of standard

If the result exceeds 20 mmol/L, the sample should be diluted 1:1 with normal saline, ran again, and the result multiplied by 2.

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1.Purpose

Quantitative determination of active tPA

2.Scope and Applicability

Human tPA Total Antigen ELISA may be used for quantitative determination of totaltPA in cell culture and tissue lysate samples as well as human plasma and otherbiologicalfluids.

3.Summary of Method

Biotinylated Human PAI-1 Addition
Preparation of Standard
Standard and unknown addition
Primary antibody addition
Secondary antibody addition
Substrate incubation
Measurement
Calculation of results

4.References

Molecular Innovations Human tPA Activity ELISA Kit (Cat # HTPAKT) Manual
Bio Rad iMark Microplate Absorbance Reader SOP

5.Precautions: NA

6.Responsibilities

It is the responsibility of the Supervisor to ensure that this SOP is performed as described and to update the procedure when necessary.
It is the responsibility of the Analyst to follow the SOP as described and to inform the instructor about any deviations or problems that may occur while performing the procedure.

7.Equipment and Materials

Molecular Innovations Human tPA Activity ELISA Kit (Cat # HTPAKT)
20µl, 200µl, and 1000µl pipettes and tips
Shaking platform capable of reaching 300rpm
Bio Rad iMark Microplate Absorbance Reader
Microtubes and rack
Blocking Buffer (3% BSA (w/v) in TBS buffer (0.1M Tris, 0.15M NaCl, pH 7.4))
1M HCl
1X washing Buffer
tPA Samples from Spinner Flask and Bioreactor

8.Procedure

Biotinylated Human PAI-1 Addition
1. Remove microtiter plate from the bag and add 100µl of Biotinylated Human PAI- 1 to all wells.
2. Shake plate at 300rpm for 30 minutes.
3. Wash wells three times with 300µl of wash buffer. Remove excess wash buffer by gently tapping microtiter plate on a paper towel or kimwipe.
Preparation of Standard (Dilutions for the standard curve and zero standard must be made and applied to the plate immediately)

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1.Purpose:

To quantify the relative amount of aggregated and monomer molecules in solution of a monoclonal antibody (mAb) drug substance using size exclusion high performance liquid chromatography (HPLC) analysis.

2.Scope:

Size Exclusion High performance liquid chromatography (HPLC) is an analytical chemistry technique for separating the components of a liquid sample based on molecular size. This SOP uses HPLC to detect the presence of monoclonal antibody aggregates or degradation products in a drug substance sample. HPLC is an FDA required test to adequately characterize the unconjugated mAb reagent of a drug product.

3.Summary of Method:

*Note: If the column is in long-term storage conditions, it requires ~3 hours of run-time to setup as described in 9.2. The system can be prepared for short-term storage conditions in mobile phase the previous day.

Prepare the mobile phase solution
Power up the HPLC system and equilibrate with mobile phase solution for 60 minutes [if system is in short-term storage] or 120 minutes [if system is in long-term storage].
Prepare AdvanceBio SEC 300Å protein standards
Prepare mAb drug substance for HPLC analysis
Prepare buffer in which mAb drug substance is suspended.
Power up the HPLC system and equilibrate with mobile phase solution
Run an assay for using the prepared AdvanceBio SEC 300Å protein standards and mAb sample
Prepare HPLC system of short-term or long-term storage.
Compute the size of the conjugated and unconjugated mAb sample

4.References:

SOP: Degassing a Solution by Helium Sparge
User Guide for Agilent AdvanceBio SEC Columns

5.Definitions:

CV	Column Volume; the volume (ml) of the column containing the stationary phase; CV= 2.91 ml for a standard size (4.6 X 150 mm) column
Equilibrium		Running the mobile phase solution through the column prior to injecting the sample in order to bring the system into equilibrium
Flow rate		The rate (ml/min) that solution is pumped through the column. The operating flow rate is determined by the assay protocol.
Helium Sparge		Using a stream of helium bubbles to sweep dissolved air out of liquids (helium is virtually insoluble in most HPLC solvent solutions, so very little helium replaces the air)
HPLC		High Performance Liquid Chromatography
Isocratic		The composition of the mobile phase solution is constant; the system has only one pump.
Long-term storage conditions		In long-term storage the system is stored in 20% ethanol for one week or longer.
Mobile phase		The solvent solution used to carry the sample through the column
PeakSimple		Software used to collect and display data
PSI		Pounds per Square Inch
Short-term storage conditions		In short-term storage the system is stored in mobile phase solution for up to a one week
Size exclusion chromatography		Separation based on molecule size. Molecules are separated on the basis of their exclusion from pores in the column packing material.
Stationary phase		The chromatography matrix through which the sample travels.

6.Precautions:

HPLC systems operate at high pressures. Personal injury and equipment damage can result if maximum pressure is exceeded, or the pump runs dry. Monitor pressure readings and solution level whenever the pump is running. If pressure exceeds 2500 psi or if the solution runs out, stop the pump immediately by pressing the RUN/STOP button. Do not set the flow rate higher than 1.5 ml/min with a 250 mm column.
Flow rate consistency is affected by the quality of the solutions. Use HPLC-grade solvents and filter solutions using a sub-micron filter (preferably 0.22 μm). Degas solutions prior to use.
To avoid microbial growth, do not leave the system in a high aqueous solution for a prolonged period. The system should be washed with a storage solution of 20% Ethanol if it is to be idle more than a week.

7.Responsibilities

It is the responsibility of the Supervisor to ensure that this SOP is performed as described and to update the procedure when necessary.
It is the responsibility of the Analyst to follow the SOP as described and to inform the instructor about any deviations or problems that may occur while performing the procedure.

8.Equipment and Materials:

Buck Scientific BLC-20P HPLC system pre-configured with:
1. UV-Vis detector
2. PeakSimple Chromatography Data System
3. Computer system with PeakSimple software installed
4. AdvanceBIO 300Å- 4.6mm x 150mm HPLC column. Product # PL1580-3301
HPLC-grade methanol
HPLC-grade water
monosodium phosphate monohydrate
disodium phosphate, heptahydrate
20% Ethanol
AdvanceBio SEC 300Å protein standards. Product # 5190-9417
Post protein A chromatography monoclonal antibody (mAb) sample to be analyzed
Sample overflow waste beaker
Analytic balance
500ml graduated cylinder
500ml volumetric flask
100ml volumetric flask
1.5ml Eppendorf Tube
Stirring plate
2- 500ml laboratory bottles (for mobile phase solution and waste)
125ml laboratory bottle (for mobile phase to rinse the sample syringe)
Nalgene Rapid-flow filtration unit
0.22μm syringe filters
5 ml Luer-Lok syringe
100uL HPLC sample syringe (Hamilton syringe)
Parafilm
Timer

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Biological/Vaccine SOPs

List Of SOPs

The isolation/purification of anti IL-8 monoclonal antibodies, (IgG) from CHO DP12 conditioned media using gravity flow protein A chromatography.

To detect Human Serum Albumin (HSA) via Enzyme Linked Immunosorbent Assay (ELISA) and quantify the concentration of HSA in each sample.

To perform tangential flow filtration

Use of the Glucose Determination Assay.

Applies to the quantitative determination of Glucose in Conditioned Media

To perform the Lactate Determination Assay by using spectrophotometry test.

Applies to the quantitative determination of Lactate in Conditioned Media.

Quantitative determination of active tPA

Human tPA Total Antigen ELISA may be used for quantitative determination of totaltPA in cell culture and tissue lysate samples as well as human plasma and otherbiologicalfluids.

To quantify the relative amount of aggregated and monomer molecules in solution of a monoclonal antibody (mAb) drug substance using size exclusion high performance liquid chromatography (HPLC) analysis.