Universal PK Tool Antibody Service for Antibody Drug

Skip the generation of anti-idiotype antibodies

Acquire universal PK tool antibodies in one week

Universal PK Tool Antibody for Antibody Drug

Anti-idiotype antibodies(Anti-ID Abs) are commonly used in pharmacokinetic (PK) analysis of antibody drugs , but it usually takes 6 months in advance in antibody generation, which is the rate limiting step in drug development. ProBio successfully developed a panel of universal PK tool antibody for PK testing before IND in mAb and ADC drugs, it will accelerate your preclinical study by skipping the generation of anti-idiotype antibody. This antibody panel contains more than ten pairs of anti-human IgG antibodies, which can specifically recognize human Fc, and have good performance in sensitivity, specificity and accuracy for PK testing in discovery and preclinical stage . You can acquire those Ab pairs in 1 week from ProBio.

Service Properties

Universal PK Tool Antibody Panel for Antibody Drug:

Biological source	Mouse/Rabbit
Modality	mAb/ADC
Approach	Hybridoma development/Phage display library
Antibody from	Hybridoma cell supernatant/ Recombination expression
Drug isotype	IgG1/IgG2/IgG4
Pairing Antibodies	>10 pairs (continue to expand)
Matrix validation	Mouse/rat/rabbit/canine/cyno
Sensitivity	0.1 ng/mL~10 ng/mL
Linear range	0.1 ng/mL~1000 ng/mL

Those universal antibodies are validated in different matrixes (mouse/rat/dog/cyno), and could be bound and paired to more than 30 antibody drugs(mAb, ADC) in IgG1, IgG2, IgG4 subtypes.

Service flowchart

The generation of anti-id Abs take at least 13-14 weeks , requiring animal immunization and fusion screening.
The universal PK tool Abs can skip the generation of anti-idiotype antibody, and obtain the paired antibody pair in 1 week.

Universal PK Tool Antibody for Antibody Drug

Anti-ID Ab

Service Features

Service package

Universal PK Tool Antibody Pairs Package

ProBio can provide you with paired antibody screening services. You only need to provide targeted antibody drugs, and you can get guaranteed paired antibodies for PK methodology development as soon as 1 week.

Milestone	Items	Description	TAT(wks)	Deliverables*
0	Antibody drug preparation	≥ 0.5-1mg target antibody drug (customer provide, purity > 85%)	/	1 mg Biotin Labelled antibody 1 mg unlabeled antibody Sensitivity<10ng, Stability: >5 years Report of antibody pairing
1	Pilot binding assay	Binding screening Antibody pairing	1w
2	Ab production	PK tool antibody pair 1mg detecting antibody 1mg capture antibody	2-3W
total			3-4W

*If no binders are identified after screening, the project will be terminated and 20% price of milestone 1 will be charged.

Universal PK Tool Antibody panel Package

You can select interested antibodies to purchase in the universal PK tool panel and do not have to pay for binding services fee. Welcome to contact us for more service details.

PK ELISA Kit Development and Manufacturing Package

ProBio can establish a universal Sandwich ELISA detection method for the Fc fragment for you, and provide high-quality and high-stability kit development and production services.

Milestone	Description	TAT(wks)	Deliverables*
Binding assay and Ab production	Universal Anti-Human IgG Ab pair (ProBio provides)	1W
Kit feasibility analysis for PK	≥ 0.5mg antibody drug (customer provides) Antibody sensitivity analysis of Sandwich ELISA	1-2w	Report of feasibility analysis Final report of kit development
Kit development and manufacturing	Adjustment of the test conditions;	2-3w
	Determination of kit parameters.	2-3w
	Kit verification	3-4w
Kit delivery	10 kits	/	10 kits
Additional kit manufacturing	/	/
total		~2 M

Case study

PK ELISA for mAb-Binding assay of various types of antibody drugs:

These antibodies were validated to bind and pair with multiple antibody drugs (mAb, ADC) with the IgG1, IgG2, IgG4 subtype

These antibodies don't have cross-reaction with IgG of various species like mouse, rat, dog and cyno.>/p>

PK ELISA for mAb-Antibody Pairing:：

The success rate of immunoassay development could largely increase when using Sandwich ELISA to select universal PK antibody pair.

Capture mAb, 2μg/ml Buffer	Concentration of mAb (ng/ml)				Detection mAb,0.5μg/ml
Capture mAb, 2μg/ml Buffer	1000	100	100	0	Detection mAb,0.5μg/ml
mAb17	3.632	0.647	0.088	0.045	mAb4-biotin
mAb18	3.624	0.721	0.092	0.047	mAb4-biotin
mAb17	3.857	0.969	0.118	0.046	mAb5-biotin
mAb18	3.783	0.973	0.115	0.047	mAb5-biotin

As it was shown in the table, mAb17 and mAb17 are able to pair with mAb4 and mAb5.

PK ELISA for mAb-Establish Standard Curve:

Batch	Plate	Nominal Conc.(ng/mL)	32	16	8	4	2	1	0.5	R²
Batch 1	Plate 1	Measured Conc. (ng/mL)	31.952	16.113	7.853	4.091	2.006	0.984	0.529	0.99992
Batch 1	Plate 1	RD (%)	-0.1%	0.7%	-1.8%	2.3%	0.3%	-1.6%	5.8%	0.99992
Batch 2	Plate 1	Measured Conc. (ng/mL)	32.038	15.876	8.169	3.947	1.963	0.940	0.515	0.99991
Batch 2	Plate 1	RD (%)	0.1%	-0.8%	2.1%	-1.3%	-1.9%	-6.0%	3.0%	0.99991
Batch 3	Plate 1	Measured Conc. (ng/mL)	32.083	15.765	8.248	4.025	1.872	0.905	0.512	0.99975
Batch 3	Plate 1	RD (%)	0.3%	-1.5%	3.1%	0.6%	-6.4%	-9.5%	2.4%	0.99975

The standard curve was demonstrated to be consistent by three independent experiments.

PK ELISA for mAb-Matrix Validation:

The standard curve can be well established in the influence of the matrix of four animal models

PK ELISA for mAb-Sensitivity(Detection Limit, DL):

As it was shown in the table, the mean of LOD is 0.0107ng/mL and show great sensitivity

Date	Date1						Date2
Batch	Batch 1			Batch 2			Batch 1			Batch 2
Sample	Zero Std			Zero Std			Zero Std			Zero Std
OD 450 nm	0.056	0.055	0.056	0.062	0.059	0.065	0.051	0.052	0.052	0.051	0.052	0.054
	0.054	0.055	0.055	0.054	0.054	0.056	0.049	0.052	0.050	0.050	0.050	0.051
	0.049	0.093	0.060	0.059	0.061	0.060	0.050	0.048	0.049	0.051	0.049	0.050
	0.052	0.061	0.051	0.053	0.057	0.059	0.049	0.053	0.052	0.050	0.060	0.050
	0.051	0.067	0.061	0.059	0.052	0.060	0.051	0.050	0.052	0.051	0.049	0.051
	0.049	0.067	0.061	0.052	0.055	0.058	0.052	0.057	0.050	0.051	0.049	0.051
	0.047	0.056	0.052	0.057	0.063	0.066	0.052	0.051	0.050	0.053	0.050	0.051
	0.050	0.056	0.053	0.053	0.063	0.073	0.049	0.051	0.051	0.054	0.052	0.050
Mean	0.057			0.059			0.051			0.051
SD	0.009			0.005			0.002			0.002
Mean+2SD	0.075			0.069			0.055			0.055
Standard Curve	Equation: y = (A - D) / [1 + (x/C)^B] + D A = 3.67401 B = -1.08918 C = 4.34544 D = 0.07120 r^2 = 0.99978			Equation: y = (A - D) / [1 + (x/C)^B] + D A = 5.27785 B = -1.03506 C = 7.35607 D = 0.06746 r^2 = 0.99992			Equation: y = (A - D) / [1 + (x/C)^B] + D A = 5.59843 B = -0.98803 C = 12.30756 D = 0.04538 r^2 = 0.99996			Equation: y = (A - D) / [1 + (x/C)^B] + D A = 4.43314 B = -1.05590 C = 8.18800 D = 0.05328 r^2 = 0.99999
LOD (ng/mL)	0.010			0.003			0.020			0.010
Mean of LOD (ng/mL)	0.0107

Inquiry and order

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