ADC Formulation Development
Around 600 ADCs are currently in clinical development*， ADCs are transforming the landscape of targeted therapies and offering innovative solutions across oncology and non-oncology indications, driving the advancement of innovative treatments.
ADC formulation development is crucial in turning the potential of these pipeline into tangible clinical benefits. However, challenges remain，including maintaining consistent quality, overcoming formulation complexities, and scaling production. The demand for flexible, efficient, and scalable ADC formulation development solutions is growing.
At ChemExpress, we offer tailored, effective and stable ADC aqueous injection and lyophilized formulation development services that align with your Target Product Profile (TPP)，enabling your therapies to navigate challenges, differentiate in the market and accelerate their path to success.
*Source: Beacon ADC by Hanson Wade 2025
One-Stop ADC
CDMO Service
ChemExpress offers integrated services spanning from Payload-Linker to ADC DS&DP, enabling efficient scale-up and seamless technology transfer, effectively reducing management and transition costs.
Extensive Project Experience
& Comprehensive Inventory
Over 160 ADC projects have been delivered, including over 60 CMC projects, 5 BLA projects, and 1 commercial project. 15 ADC payloads and related intermediates are registered with the FDA as DMFs.
Expert Scientific
Team
Our team of over 500 scientists provides comprehensive support from R&D to commercialization, ensuring high-quality, scalable solutions for your ADC pipeline.
Our Services
Partner with us for streamlined ADC formulation development, from early-stage preformulation through to scalable production. Our tailored solutions minimize risks, accelerate timelines, and expedite your innovations to market faster.
Our Service Scope Includes
Preformulation
- Solubility & Stability Profiling
- Drug-Likeness Evaluation
Prescription Screening
- Buffer System Optimization
- Stabilizer Screening
- Excipient Screening
ADC Formulation Development
- Aqueous Injection & Lyophilized Formulation Development
- ADC Lyophilization Cycle Development & Optimization
- ADC Formulation Process Development
- Stability of Use Experiments
- Bacterial Retention Validation
- ADC Formulation Process Characterization
Why Partner with ChemExpress
One-stop Service
Seamless integration from payload-linker to ADC drug substance and ADC formulation optimization, ensuring enhanced stability, efficacy, and scalability at each development stage，while effectively reducing management and transition costs
Customized Formulation & Design of Experiment
Optimize formulation to improve drug characteristics, streamline production, and give your product a competitive market edge
Optimized Production Capacity
Advanced lyophilized formulation technology, with fully equipped lines for 2ml, 20ml, 50ml aqueous injections and lyophilized, ensuring timely delivery
Green Chemistry & Sustainability
Lyophilization and excipient systems for enhanced temperature stability, to mitigate dependence on energy-intensive cold chains and enhance sustainability in ADC formulation development
Our Sites
Manufacturing Site
Chongqing ADC CDMO Manufacturing Site
XDC Process Development and Manufacturing· Types: syringe vials aqueous injection, syringe vials lyophilization
· 1 DP filling Line (with Lyophilizer) : 10m²、25m²
· Annual production capacity: 2 million bottles/year; Annual output: 50
batches.
Related Services
ADC Drug Substance Process Development
Partner with ChemExpress for cutting-edge, efficient ADC drug substance process development, from Payload-Linker synthesis to conjugation.
ADC Conjugation
At ChemExpress, our expert team offers flexible and scalable ADC conjugation solutions covering both site-specific and non-site-specific technologies.
ADC Manufacturing
We provide cGMP-compliant bioconjugate manufacturing services for R&D, clinical and commercial stages, covering the entire ADC production process.
Antibody Process Development
ChemExpress can offer comprehensive antibody process development solutions covering cell culture process development, purification process development and formulation process development, enabling rapid, cost-effective, and high-quality antibody production.
ADC Payload Linker
We specialize in complex and novel Payload-Linker, offering fully customized synthesis services to meet the specific needs of client projects.
Case Study
During the development of the ADC lyophilized formulation, early trials showed abnormal appearance such as wall-sticking, shrinkage, collapse, and crusting. By applying our lyophilization process development platform, one round of lyophilization curve adjustment was performed.
The outcome demonstrated a significant improvement: the lyophilized cake exhibited good appearance with uniform morphology.
FAQs
Liquid formulations are becoming a trend due to their convenience (e.g., subcutaneous injection), but several challenges need to be overcome:
· Long-term stability (e.g., suppressing toxin degradation, such as VC-MMAE, which has a stability of less than one month at 40°C)
· Uniformity at low concentrations (ADC clinical doses are often below 1 mg/mL)
· Aseptic filling processes (to prevent contamination by highly active toxins)
DOE is used for efficient optimization of ADC formulation parameters, such as:
· Formulation screening: Using Response Surface Methodology (RSM) to analyze the interaction between buffer types, pH, and stabilizer concentrations.
· Lyophilization process development: Designing temperature gradient experiments (e.g., -40°C to 25°C) to determine the optimal primary drying conditions.
