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Cell Line Development

Cell Line Development

Cell Line Development Services

Intellective Bio provides end-to-end cell line development solutions, from gene to GMP Working Cell Bank, to accelerate clients’ biotherapeutic programs from early-stage R&D to commercial production.Leveraging advanced vector construction, high-throughput screening platforms, and extensive expertise enable us to deliver high-yield, stable, and regulatory-compliant cell lines.

High-Performance CHO-K1-Based

Cell Line Development Platform

Intellective Bio has established proprietary host cell lines, expression vectors, and culture media technologies, enabling cell line development for a wide range of molecular modalities. We offer various risk-based filing strategies to meet the needs of clients and enable IND submission in as short as 9 months .Leveraging our robust and reliable cell line screening platform, Intellective Bio has successfully supported cell line development for more than 300 molecules, contributed to over 50 clinical approvals, and advanced more than 30 programs into clinical development.

Cell Line Development Workflow

01

Vector

Construction

02

Cell

Transfection

03

Pool/Minipool Screening

04

Pool/Minipool Fed-Batch Evaluation

05

Pool/Minipool Clonal Derivation

06

Plate-Based Screening

07

Clone Fed-Batch Evaluation

08

PCB Banking and Stability Assessment

Flexible Timelines & Delivery

Intellective Bio’s latest “Fast-to-IND” service is designed to accelerate development timelines by delivering an IND-enabling data package within 9 months and providing a Master Cell Bank (MCB) within 3 months.We offer flexible technical scopes and project timelines tailored to specific program needs. As illustrated, starting from host cell transfection, the fastest timeline enables sequence-to-Preliminary Cell Bank (PCB) generation within just 3 months. This streamlined platform supports IND development timelines ranging from 9 to 14 months, helping clients advance their programs to the clinic with greater speed and confidence.

Standard Timeline(Months)

1
2
3
4
5
6
7
8
9
10
11
12
Cell Line Development
MCB Cell Bank Stability
Upstream Process Development
Downstream Process Development
15 L Pool Material
FD 1st Screening
FD 2nd Screening
Analysis Methods Development and Qualification
MCB
WCB
Non-GMP lot
DP
Stability Study(3M)
Testing
GMP lot
DP
IND Dossier
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