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Antibodies and Proteins for Cell Therapy – CMC Development and GMP Manufacturing Services

Antibodies and Proteins in Cell Therapy

Flexible, end-to-end solutions for IIT material, IND material and GMP raw material in as fast as 3.5 months from DNA to IIT material.
Overview
Workflow
Case Studies
Related Services
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Built for the Unique Needs of Cell Therapy

Light CMC Solutions

  • GMP material packages
  • IIT and IND-ready options
  • Support for raw materials and APIs

Fast-Track Development

  • DNA to IIT material in as fast as 3.5 months
  • DNA to tox batch in as fast as 4 months
  • DNA to GMP batch in 6 months

Advanced Development Expertise

  • Cell line development expertise
  • ProBox process and analytical development
  • Experience with cytokines, bispecifics, and trispecific antibodies

Flexible GMP Manufacturing Scale

  • 25L – 2000L GMP production
  • EU QP-audited facility

Flexible CMC Support from Raw Materials to Antibody APIs

Antibodies and Proteins in Cell Therapy workflow A ten-stage timeline above three solution cards for GMP material, IIT solution, and IND solution. 0 1 2 3 4 5 6 7 8 9 GMP Material 6 months • 6 months from DNA to GMP batch IIT Solution 3.5~4.5 months • mAb: 3.5 months from DNA to IIT material• bsAb: 4.5 months from DNA to IIT material IND Solution 4~5.5 months • mAb: 4 months from DNA to Tox batch• bsAb: 5.5 months from DNA to Tox batch• Preserves sample integrity, particularly forvaluable serum samples.

Case Studies

GMP Material Gantt Chart: 5 months from DNA to GMP batch.

Antibodies and Proteins in Cell Therapy Case Study Antibodies and Proteins in Cell Therapy Case Study. A six-month Gantt chart covering stable cell line development, cell bank generation, process evaluation, quality study, critical raw material GMP production, and stability study. Milestones Service Content Timeline（month） 1 2 3 4 5 6 Stable cell line development Cell bank generation Process evaluation Quality study Critical Raw material GMP production Stability study Gene synthesis & plasmid preparation Stable cell pool screening Single cell clone screening and PCB generation MCB generation MCB stability study (30 generations) 2L fed-batch cell culture process evaluation Purification process evaluation Method qualification 25L GMP production Release test of DS stability study of DS PCB MCB DS continued

IIT Solution: 3.5 months from DNA to IIT material (mAb), 4 months from DNA to IIT material (bsAb).

Antibodies and Proteins in Cell Therapy Case Study Antibodies and Proteins in Cell Therapy Case Study. A six-month Gantt chart covering stable cell line development, cell bank generation, process evaluation, quality study, critical raw material GMP production, and stability study. Milestones Service Content Timeline（month） 1 2 3 4 5 6 Stable cell line development Cell bank generation Process evaluation Quality study Critical Raw material GMP production Stability study Gene synthesis & plasmid preparation Stable cell pool screening Single cell clone screening and PCB generation MCB generation MCB stability study (30 generations) 2L fed-batch cell culture process evaluation Purification process evaluation Method qualification 25L GMP production Release test of DS stability study of DS PCB MCB DS continued

IND Solution: 4.5 months from DNA to Tox batch (mAb), 5.5 months from DNA to Tox batch (bsAb).

Antibodies and Proteins in Cell Therapy Case Study Antibodies and Proteins in Cell Therapy Case Study. A six-month Gantt chart covering stable cell line development, cell bank generation, process evaluation, quality study, critical raw material GMP production, and stability study. Milestones Service Content Timeline（month） 1 2 3 4 5 6 Stable cell line development Cell bank generation Process evaluation Quality study Critical Raw material GMP production Stability study Gene synthesis & plasmid preparation Stable cell pool screening Single cell clone screening and PCB generation MCB generation MCB stability study (30 generations) 2L fed-batch cell culture process evaluation Purification process evaluation Method qualification 25L GMP production Release test of DS stability study of DS PCB MCB DS continued

Resources

Resource HandBook – Your CMC Partner to IND: Integrated CMC Solutions for Antibodies and Proteins in Cell Therapy

HAND

BOOK

Your CMC Partner to IND

Integrated CMC solutions for complex biologics—built for speed, flexibility, and reliability.
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In Vivo CAR-T Antibody Discovery and Development

WEBINAR

In Vivo CAR-T Antibody Discovery and Development

Practical strategies for accelerating antibody discovery and development for in vivo CAR-T therapies.
Watch On-Demand
A fast-track CMC platform delivering IND-ready material with unmatched speed

HAND

BOOK

ExpressCMC

A fast-track CMC platform delivering IND-ready material with unmatched speed.
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