Version: 1.0 (2025)

Release date: 2025-11-01

Authors: Diogo Magnani; Julia Vasconcellos; Giovanni de Castro; Vimala Gollamudi

Corresponding PI: Diogo Magnani

Funder: Office of Research Infrastructure Programs (ORIP)

Award Number: 5P40OD028116-07

Data Repository: Dryad Digital Repository (doi:10.5061/dryad.612jm64jt)

Recommended citation: NHPRR Antibody Qualification and Performance Data (5P40OD028116-07). Dryad Digital Repository, Version 1.0, released 2025-11-01. https://doi.org/10.5061/dryad.612jm64jt

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1. Overview

This dataset contains qualification and performance data for immune cell–depleting and control antibody reagents produced by the Nonhuman Primate Reagent Resource (NHPRR) under NIH grant 5P40OD028116-07.

Version 1 includes data generated for NHPRR purified protein lots produced between January 1, 2025, and October 1, 2025.

The dataset supports reagent reproducibility, concentration, purity, and endotoxin validation for nonhuman primate use, in compliance with the NHPRR Data Management and Sharing Plan.

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2. Contents

A. Processed / Analytical Data

• Endotoxin_data.csv — Raw Limulus Amebocyte Lysate (LAL) test results, reported as EU/mg for each reagent lot.
• Concentration_data.csv — Protein concentration measurements determined by UV absorbance at 280 nm, reported in mg/mL.
• Concentration_summary.csv — Combined summary of replicate concentration data with mean and standard deviation.
• Summary_level_QC_results.csv — Aggregated summary combining concentration, endotoxin, pH, and SEC results for each lot; values correspond to those reported in Certificates of Analysis (CoA)

B. Raw Instrument Data

• 2025.10.10_PPLOT00367_SEC_AB_2819341_Anti-CD20_2B8R1F8_Afucosylated.zip — Size Exclusion Chromatography (SEC) data for antibody lot PPLOT00367; AKTA UNICORN™ raw data files.
• 2025.10.14_PPLOT00443_SEC_AB_2819341_Anti-CD20_2B8R1F8_Afucosylated.zip — SEC data for antibody lot PPLOT00443; AKTA UNICORN™ raw data files.
• 2025.03.12_PPLOT00335_SEC_AB_3678571_Anti-PD1_pere.zip — SEC data for antibody lot PPLOT00335; AKTA UNICORN™ raw data files.

C. Documentation

• 2025.10.28_TDS_files.zip — Technical Datasheets (TDS) summarizing reagent specifications, storage conditions, and intended use.
• 2025-10-28-CoA-PPLOT00443_Anti-CD20_2B8R1F8-Afucosylated.pdf — Certificate of Analysis (CoA) for lot PPLOT00443, including lot-specific QC results and approvals.
• 2025-10-28-CoA-PPLOT00367_Anti-CD20_2B8R1F8-Afucosylated.pdf — Certificate of Analysis (CoA) for lot PPLOT00367, including lot-specific QC results and approvals.
• 2025-10-28-CoA-PPLOT00335_Anti-PD1_pere.pdf — Certificate of Analysis (CoA) for lot PPLOT00335, including lot-specific QC results and approvals.

D. General field names shared across all files:RRID — The preferred Research Resource Identifier for each antibody reagent.

• CAT number — The NHPRR catalog identifier. When cited, specify NHPRR as the vendor to ensure unambiguous reference.
• Product name — The antibody product name. Note that product names alone are not guaranteed to be unique across vendors.
• Lot number — The lot identifier (e.g., PPLOT00443). Multiple lots may exist for a single product.
• Test date — The date the measurement or assay was performed.

For more information about NHPRR products, visit https://www.nhpreagents.org

For information about Research Resource Identifiers (RRIDs), visit https://www.rrids.org

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3. Data Standards and Formats

Most data are provided in open, non-proprietary formats (CSV, PDF, TXT).

Size Exclusion Chromatography data are supplied as ZIP archives containing UNICORN™ files generated by the AKTA system.

All datasets follow FAIR principles and MIAPAR standards for antibody reagent reporting.

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4. Quality Control and Methods

All reagents were qualified according to NHPRR Standard Operating Procedures.

Analyses included the following:

• Concentration: Determined by UV absorbance at 280 nm using standard spectrophotometric methods.
• Endotoxin: Measured using the Limulus Amebocyte Lysate (LAL) chromogenic assay. Results are expressed as EU/mg. Endotoxin limits comply with U.S. FDA guidance, not exceeding 5 EU/kg/hour, the reference standard for intravenous infusion in human and nonhuman primate studies.
• pH: Measured directly using a calibrated pH meter.
• Size Exclusion Chromatography (SEC): Performed using the AKTA UNICORN™ system. SEC data are provided as UNICORN™ files packaged in ZIP format.
• Documentation: Each reagent lot is accompanied by a Certificate of Analysis (CoA) and a Technical Datasheet (TDS) summarizing test results, formulation buffer, and usage information.

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5. Ethical and Privacy Statement

This dataset does not contain data from human or animal subjects.

All results represent in-vitro analytical characterization of antibody reagents.

Certificates of Analysis list QC approvers as part of standard documentation; no personal or confidential information is included.

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6. Description of the data and file structure

The files included in this dataset contain Quality Control (QC) measurements for NHPRR purified protein lots produced in 2025. Each file name follows the convention YYYY.MM.DD_LotNumber_FileType for clarity and traceability.

Description of files

The final calculated values are found in the summary files. For endotoxin and concentration, their respective CSV data files contain the replicate measurements used to calculate final results.

Summary_level_QC_results.csv:

It is the file containing the final calculated values of all lots.

The "Status" columns for measurements are the status designed after the QC specialist reviewed the measurement notes.

• Empty or null indicates that the result has not been registered or is yet to be sent for review.
• NEEDS_REVIEW is for when it was submitted for review
• ACCEPTED is when the note was reviewed. It does not mean it passed a QC control, only that it went by the review process as it was acknowledged, which means this is a valid measurement.

The "Test date" and its measurements are in tuples, which means they are arrays where the first date is associated with the first measured value, the second date is associated with the second measured value, and so on.

QC status - Represents the current stage of the QC analysis as of the date shown in the "QC report date" field. Currently, possible values for the "QC status" are:

• NOT STARTED
• RETAIN REQUESTED
• IN PROCESS
• APPROVED
• UNDER INVESTIGATION
• FAILED

Report number - The identifier of the CoA for the current QC stage.

Lot date - The date the lot was produced.

Concentration_summary.csv

This structured table contains the final calculated concentration values for each purified protein lot.

• Purified Protein Lot (PPLOT) - The unique identifier for the purified protein lot being tested
• Lot number - The lot number identifier (e.g., PPLOT00443, PPLOT00367, PPLOT00335)
• Product Name - The name of the antibody product (e.g., Anti-CD20 [2B8R1F8]-Afucosylated, Anti-PD1 [pere])
• CAT number - The NHPRR catalog number that identifies the product (e.g., CAT-00291, CAT-00389)
• RRID - The Research Resource Identifier, the preferred unique identifier for products (e.g., AB_2819341, AB_3678571)
• CRO Performing Analysis - The organization that performed the concentration analysis (e.g., NHPRR)
• Instrument - The instrument used for measurement
• Test date - The date when the concentration measurement was performed
• Concentration (mg/mL) - The final calculated protein concentration in milligrams per milliliter

Concentration_data.csv

This file contains the detailed spectrophotometry data from the NanoDrop instrument used to calculate the final concentration values.

• Lot number - The lot number identifier
• Product name - The antibody product name
• CAT number - The catalog number
• RRID - The Research Resource Identifier
• Date/Time - The exact timestamp when each replicate measurement was taken
• Sample Name - The identifier for each replicate sample (e.g., PPLOT00367_Replicate_1, PPLOT00335_Rep_1)
• Conc (mg/mL) - The concentration measurement for each individual replicate
• A280 - The absorbance reading at 280 nanometers wavelength
• A260/A280 - The ratio of absorbance at 260nm to 280nm, used to assess purity
• Sample Type - The type of protein analysis method used

Endotoxin_summary.csv

This plain table contains the final endotoxin test results and quality control assessments for each lot.

• Lot number - The lot number identifier
• Product name - The antibody product name
• CAT number - The catalog number
• RRID - The Research Resource Identifier
• CRO Performing Analysis - The organization that performed the endotoxin testing (e.g., NHPRR)
• Endotoxin (EU/mg) - The endotoxin level measured in Endotoxin Units per milligram of protein
• QC specialist Pass/Fail - The quality control assessment result (Pass or Fail) determined by the QC specialist
• Instrument - The instrument used for endotoxin measurement (Nexgen PTS (endotoxin))
• Test date - The date when the endotoxin test was performed
• Notes - Additional comments or observations about the test

Endotoxin_data.csv

This plain table contains the detailed raw data from the Nexgen PTS endotoxin testing instrument, including all technical parameters and quality metrics.

• Lot number - The lot number identifier
• Product name - The antibody product name
• CAT number - The catalog number
• RRID - The Research Resource Identifier
• Instrument - The endotoxin testing instrument (Nexgen PTS (endotoxin))
• Software version - The version of the PTS software used (e.g., PTS150 V11.0.0)
• Test Date - The date when the endotoxin test was performed
• Sample Name - The identifier for the sample being tested
• Onset Time 1 (Sec) - The reaction onset time in seconds for the first replicate (>745 indicates no reaction detected)
• Onset Time 2 (Sec) - The reaction onset time in seconds for the second replicate
• Onset Time 3 (Sec) - The reaction onset time in seconds for the third replicate (spike control)
• Onset Time 4 (Sec) - The reaction onset time in seconds for the fourth replicate (spike control)
• Sample #1 (EU/mL) - The endotoxin concentration for the first sample replicate (<1.00 indicates below detection limit)
• Sample #2 (EU/mL) - The endotoxin concentration for the second sample replicate
• Sample Avg (EU/mL) - The average endotoxin concentration across sample replicates
• Spike Value (EU/mL) - The endotoxin concentration measured in the spiked control sample
• Sample Rxn Time CV (%) - The coefficient of variation for sample reaction times, indicating measurement precision
• Spike Rxn Time CV (%) - The coefficient of variation for spike control reaction times
• Spike Recovery (%) - The percentage recovery of the spiked endotoxin, used to validate the assay
• Slope - The slope of the calibration curve used for endotoxin quantification
• Intercept - The y-intercept of the calibration curve
• Dilution - The dilution factor applied to the sample (e.g., 1:20)
• Cartridge Cal Code - The calibration code for the test cartridge used
• Range - The detection range of the assay (e.g., 5-0.05 EU/mL)
• Test Suitability - The overall test validity assessment (systems suitability of the instrument and cartridge)

SEC files

The ZIP-compressed SEC Unicorn files are the RAW data from the instrument that were exported using the Unicorn software.

The XML files, which can be found after uncompressing, contain the software version used, among other details.

PyCORN is an alternative open-source Python library that can be used to analyze these RES files.
PyCORN can be found on https://github.com/pyahmed/PyCORN
There is also an updated fork https://github.com/ronald-jaepel/PyCORN