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Non-GLP PK Study Services
Accelerating Early Drug Discovery with
Non-GLP NHP PK Studies
Making NHP PK Studies More Accessible for Drug Discovery
Non-human primate (NHP)–based pharmacokinetic (PK) studies are critical for predicting human PK, supporting
toxicology dose selection, and reducing late-stage development risk. However, in early discovery, NHP PK studies
are traditionally limited by cost, supply, and timelines.
ProBio’s NHP Non-GLP PK Study Service addresses these challenges by enabling high-quality, cost-effective NHP
PK studies that are practical and accessible at the discovery stage.
Cost Efficient
Fast
Multimodality
Platform
Stable Supply
Design
Turnaround
PK reports delivered in as
little as 6 weeks
Reduce study costs by
Annual stable high quality
breeding stock of
600–800
Supporting monoclonal
antibodies (mAbs)
≥50%
Includes method
development and testing
Designed for
discovery-stage budgets
Bispecific antibodies
(bsAbs) and multi-specific
antibodies
SPF-standard housing,
pre-screened and
traceable
Accelerated timelines
enabling early
decision-making
Antibody Drug Conjugates
(ADCs)
And cell and gene
therapies
Our Proven
10+
200+
100+
Experience
Years of Industry
Expertise
PK Projects /
Year
Global Clients
Served
Comprehensive Analysis Platform
01. Pharmacokinetics
02. Immunogenicity
LBA & LC-MS platform for in vivo & ex vivo stability
FACS & PCR (qPCR, ddPCR) platform for persistence,
proliferation, infiltration etc.
Pre-existing antibody screening
ADA & Anti-ID screening
Vaccine titer, including protein & mRNA vaccines
Neutralizing antibody assessment
Cytokine release analysis
PCR (qPCR, ddPCR) & RNAscope for tissue distribution
03. Biomarker Analysis
04. Early toxicology
Biomarker analysis for tumor & immune systems,
including receptor occupancy (RO)
Cytokine, chemokine, & growth factor panels
Immune cell infiltration analysis by FACS or IHC
Genomics & immunology testing
Histopathological assay (HE，IHC，Massion etc)
Tissue cross-reactivity（TCR）
Non-GLP toxicology, including single- & repeat-dose
studies
Hematology & blood chemistry analyses
ProBioCDMO.com
+1-732-885-9188
Accelerating Ideas. Delivering Impact.
Case Study
Early PK screening identified a lead candidate with optimal pharmacokinetics, comparable to
control, enabling faster and more confident decision-making.
1. Test Article Screening in Discovery Stage
Experimental design
Species: cynomolgus monkey; n=2 (NC; n=1)
Sex: 1 male, 1 female
Dose regimen: single dose, intravenous (i.v.)
Sample collection: 30 min, 2 h, 4 h, 8 h, 24 h, 2d, 3d, 5d, 7d, 14d, 21d, 28d
The results indicate that Test article 3 exhibits optimal pharmacokinetics and is comparable to the positive control.
Dose
mg/kg
T1/2
h
Cmax
mg/L
AUClast
h*mg/L
Cl_obs
mL/h/kg
Test article
NC
PC
1.67
6.27
10.64
183.06
221.16±12.91 86.45±5.43 12215.01 ±430.06 0.15± 0.01
227.1±12.01 43.85± 6.62 5159.44± 63.07 0.38±0
181.03±51.85 55.64±4.53 7347.05 ±1063.21 0.26±0.05
Test article 1
2
Test article 2
Test article 3
±
±
237.45 ±8.5
91.82±11.14 11984.03 660.7 0.16 0.01
2. Pilot PK Study for IND Support
Experimental design
Dose regimen: single dose, intravenous (i.v.)
Species: cynomolgus monkey; n=2
Sex: 1 male, 1 female
Sample collection: pre-dose, 5 min, 30 min, 2 h, 8 h, 24 h, 2d, 4d, 7d, 14d, 21d
The results indicate that the recommended starting dose for formal IND-enabling PK studies ranges from 1 to 10 mg/kg.
Dose
mg/kg
T1/2
h
Cmax
mg/L
AUClast
h*mg/L
Cl_obs
mL/h/kg
Test article
NC
PC
1.67
6.27
10.64
183.06
221.16±12.91 86.45±5.43 12215.01 ±430.06 0.15± 0.01
227.1±12.01 43.85± 6.62 5159.44± 63.07 0.38±0
181.03±51.85 55.64±4.53 7347.05 ±1063.21 0.26±0.05
Test article 1
2
Test article 2
Test article 3
±
±
237.45 ±8.5
91.82±11.14 11984.03 660.7 0.16 0.01
Service Package
Better data , better decisions, better outcomes – contact us to find out more
Study
Research Content
Time (week)
Customer Provides
ProBio Deliverables
2 non-naïve monkeys
28-day rearing period
PK methodology
Raw data
Report
Test article
PK detection key
reagents
Pre-ADA screen (4 samples)
PK method development & PK testing
(1 method, 12 time points/animal)
PK Study
6
Includes all items in the PK Study
package, plus:
PK methodology
Raw data
Report
Test article
PK detection key
reagents
Hematology & Blood Biochemistry (5
time points/animal)
PK Study Plus
6-8
Cytokine release syndrome (CRS)
testing (6 markers)