ADC & Bioconjugation Development & Manufacturing
Advance Your Program
We provide standalone manufacturing or fully integrated development and manufacturing services across all ADC components—antibodies, linkers, and payloads—along with bioconjugation and sterile fill-finish capabilities.
ADC & BIOCONJUGATION DEVELOPMENT
Accelerate Your ADC With Altruist
To support CMC-stage development activities, Altruist has built highly trained and experienced process development, analytical development, and formulation development teams specializing in antibody-drug conjugates (ADCs) and other bioconjugates.
Our expert staff deliver comprehensive process development, scale-up, and technology transfer services to enable efficient transition into GMP clinical and commercial manufacturing for our clients.
GMP DRUG SUBSTANCE MANUFACTURING
Flexible Manufacturing Processes
We offer reliable and high-quality clinical to commercial cGMP manufacturing across all the ADC components: antibodies, linkers, payloads and bioconjugation. ADC manufacturing is challenging and requires highly skilled scientific experts that can ensure the successful and safe manufacturing of these highly potent drugs – working within state-of-the-art, cGMP manufacturing facilities.
- Suzhou AXC Pilot Plant
Bioconjugation DS: 1g-1,500g/batch - Hangzhou AXC Commercial Facility
ADC DS: 20L-100L
Commercial DS: 100L-500L, 500L-5,000L* (under construction)
Additional capabilities at the Hangzhou site include:
- Technology transfer
- Formulation development (both frozen, liquid and lyophilized dosage forms)
- Drug product (DP) process development
- GMP drug product manufacturing
GMP DRUG PRODUCT MANUFACTURING
Taking You to The (Fill-)Finish Line
We provide a variety of drug product GMP filling services for antibody drug conjugates and other bioconjugates. Our services include compounding, sterile filtration, filling, lyophilization, fully stoppering, capping, external washing, visual inspection and packaging. The filling line contains a fully isolated, automated aseptic system which can fill liquid and lyophilized products in vial sizes of 2R / 6R / 10R / 20R / and 50R.
Our Capabilities:
- Fully automated, isolator-based aseptic filling system
- Vial washing machine
- Isolator-based 2 x 7.5㎡ lyophilizer
- Isolator-based 3 x 35㎡ lyophilizer (Under construction)
- Freeze-drying production capacity of up to 5 million vials/year (based on 20R vials)
- External washing
- Visual inspection
- Labeling & packaging
REGULATORY SUBMISSIONS
Compliance at Every Stage
We ensure that our production processes comply with regulatory standards, maintain detailed and traceable records for problem identification, and demonstrate both flexibility and compliance management capabilities.
- Adoption of comprehensive quality control strategy ground in risk assessment
- Collaboration between partners is paramount within segmented product models
- Research and validation must encompass entire production chain and lifecycle
Contact
Your Link to Success
Learn more about our wide range of innovative conjugation and payload-linker technologies to facilitate the development and manufacture of your ADC or bioconjugate.
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