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Anti-Idiotype Antibody Service
Anti-Idiotype Antibody Service
Anti-idiotype antibody generation & PK/ADA kit development and
manufacturing
Service Scope
16 years of experience and 1000+ projects delivered
Targeting multiple biological drug modalities：
mAb, protein/peptide, bsAb, scFv/sdAb, CAR-T, ADC and
viral vector
protein
Universal PK tool antibody for mAb and ADC in preclinical
peptide
mAB
stage, shorting the PK kit development time from 6
PK and ADA kit
Development and
Manufacturing
months to 2 months
Anti-idiotype
Antibody
One-stop service from anti-ID Ab discovery to PK and
ADA kit development and manufacturing, covering
preclinical PK andADA testing needs once for all.
DCT
bsAb
scfv sdAbCAR-T
Good compliance for experiments and record, suitable for
clinical sample testing
ADC
Guarantee to deliver ready-to-use kits for clients ordering on-stop
service
by Dec. 2024
Package Overview
Anti-idiotype antibody production
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PK capture ELISA
PK sandwich ELISA
ADA
Applicable
mAb, protein/peptide, bsAb, scFv/sdAb(CAR-T), ADC, viral vector
pAb
mAb, protein/peptide, bsAb, scFv/sdAb(CAR-T), ADC
molecule type
3-5 blocking or non-blocking
antibodies/sequences
5-10 blocking or non-blocking
antibodies/sequences
Deliverable
TAT
Human IgG1: 8-10
Human IgG2/IgG4: 10-12
Other Type#: >13
Express immunization: 3-4 months
Standard immunization: 5-6 months
*This service applies to PK analysis in preclinical and clinical stages
Universal PK Tool Antibody Pairs Package
PK sandwich ELISA
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Applicable
mAb, sdAb
molecule type
1 mg Biotin Labelled antibody
1 mg unlabeled antibody
Sensitivity<10ng/ml
Stability: >5 years
Deliverable
TAT
Report of antibody pairing
1-4w
*This service applies to PK analysis on preclinical stage
PK/ADA Kit Development and Manufacturing Package for Preclinical Use
PK ADA
100 PK kits
150 ADA kits
Report of feasibility analysis
Final report of kit development
0.5 mg Biotin labeled drug antibody
Report of feasibility analysis
Deliverable
TAT
Final report of kit development
0.5 mg Biotin Labelled anti-ID antibody &
1 mg unlabeled anti-ID antibody
2-3 months
ProBioCDMO.com
+1-732-885-9188
Accelerating Ideas. Delivering Impact.
Timing of Kit Development and Manufacturing
PK/ADA kit development at late discovery stage or cell line development stage
NDA
IND
Preclinical Development
Clinical Development
Phase III
CMC
Phase I
Phase II
Animal PK and PD
Large Efficacy
Dose Escalation
Proof of Concept
and Dose Finding
Trials with PK
and initial PK
Antibody
Discovery
Screen
Animal Toxicology（Include ADA analysis）
PK/PD study in special populations
PK data is necessary for IND application, thus PK assay/kit development is the rate limiting step in drug development
ADA assessment runs throughout the biologic drug development stages
Compliance Guidance
Data management
Records management
Complete paper-based operating procedure docu-
ments and experimental record forms.
Well-established operating procedures and manage-
ment systems to regulate the recording and review
requirements of data generated during the production
process.
Regular calibration and verification of data-generating
measuring instruments to ensure data reliability.
Raw Data are backed up in accordance with data
management requirements.
A complete quality management system for documents
and records, including processes for approval and
review of documents and records, printing and
issuance, record requirements, filing and preservation,
copying and destruction, etc.
Complete electronic record management system,
including regular inspection of computerized system,
time and time zone management, backup of system
data, operation authority and user authority manage-
ment, etc.