Antibody-drug conjugates (ADCs) are transforming oncology treatment, delivering potent therapies with precision, delivering new hope in combating cancer by directly targeting malignant cells while minimizing damage to healthy tissue.
Achieving success in ADC manufacturing means navigating a complex, multi-step development process.
At PCI, we believe that selecting the right CDMO for your new ADC is as important as selecting the right ADC components. As a partner, we offer stability, quality, strategic alignment, and a forward-thinking approach in the development and manufacturing of your ADC product, supported by full, temperature-controlled packaging, storage, and distribution services from our clinical packaging sites globally.
Three components for successfully developing ADCs
Sterile fill-finish:
Patient safety depends on drugs being packaged in a way that ensures sterility. With over 25 years of experience in delivering sterile fill-finish services, at PCI, we are a trusted partner to our clients globally in the delivery of sterile dosage forms from development to commercial scale.
Lyophilization:
Freeze drying is a key factor in extending the shelf life of ADCs. With industry-leading capabilities and over 25 years of delivering lyophilization services, our unparalleled expertise and experienced team are uniquely positioned to both develop your lyophilization cycle from scratch or optimize the existing cycle.
High-potency handling:
Properly handling highly potent ingredients protects the safety of our workforce. At PCI, we have over 35 years of experience in the development, manufacturing and packaging of highly potent drug products. With two purpose-built centers of excellence for the processing of highly potent products and a co-located high potent packaging facility, we are trusted by our global client base to deliver end-to-end solutions from early-stage clinical development through to commercialization.
Integrated ADC Development Services include:
- Development, optimization, and manufacturing services
- Process development, process optimization and, scale-up
- Formulation development (liquid and lyophilized) and drug product development
- Regulatory support
Analytical Capabilities for Development and Manufacturing
As a global leader of sterile fill-finish, lyophilization, and high potent manufacturing services, a dedicated team will support your product lifecycle with method development, method optimization, method transfer, and method qualification/validation.
Our dedicated team of specialists will be happy to discuss any of your Antibody-Drug Conjugate Product needs. Contact us on +1 215-613-3600 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com
Talk to us about our world leading antibody-drug conjugate services today.
