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Lyophilization Process
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ADC Platform
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Overview
ADC R&D Service Platform
Conjugation Process
Development
and Optimization
Drug Product
Formulation and
Lyophilization Process
Analysis Services
Antibody Manufacturing
ADC Drug Substance
Manufacturing
Lyophilized Drug
Product Manufacture
Services
– Aseptic filling
– Lyophilization
– Drug product packaging
– In-process control tests
– Drug product release test
Advantages
Established pilot- and commercial-scale manufacturing workshops, equipped with grade OEB5 isolators and lyophilizers in 5m² and 20m²
Utilizing single use filling systems, isolator integrated filling lines, and an automated loading and unloading lyophilizing system
Capable of producing lyophilized products from 2R to 50R at up to 200 vials/min
The production line uses RTP (rapid transfer port) with online weighing and light-protected features. The pilot line employs 100% full weighing control, and the commercial line includes a statistical sampling weighing module with dual-scale support
Utilizing global leading brand commercial filling line and lyophilizers, with independent designs for automated loading, unloading, and capping, enabling seamless transitions between lyophilized and liquid filling
Boasting extensive experience with more than several dozen successful production batches
Capacity of Lyophilized ADC
Vial (mL)
2
6/8
10/15
20
50
5 ㎡ lyophilizer
(Vials/batch)
22,000
11,000
9,000
6,000
3,000
20 ㎡ lyophilizer
(Vials/batch)
80,000
42,000
35,000
23,000
13,000
Equipment
The module is under construction
ADC R&D Service Request for Proposal
Name
*
Company Name
*
Tel
*
E-Mail
*
Sample Preparation Quantity
*
Conjugation Method
*
Cysteine-based site-specific conjugation
Enzyme-based site-specific glycoconjugation
Thiomab-based site-specific conjugation
ThioBridge-based site-specific conjugation
Sulfhydryl-based non-specific conjugation
Amino group based non-specific conjugation
Other alternative conjugation methods
DAR Value
*
DAR2
DAR4
DAR6
DAR8
Other specified DAR value
Large Molecular Type
*
Small Molecule Type
*
Estimated Demand Time
*
Your Specific Needs
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