Sterile Manufacturing Services

Our global manufacturing capabilities in complex formulations, high potency, and lyophilization covers a broad range of injectables including nanoparticles, mRNA, MABs, proteins, oligonucleotides, and other biologics across multiple delivery formats from vials and bottles to prefilled syringes and autoinjectors.

We provide integrated large and small molecule solutions for clinical and commercial projects, and with over 20 years in the sterile fill-finish and lyophilization manufacturing space, we are dedicated to the success of your life changing therapies.

Specialized Manufacturing of Highly Potent Sterile Products Including ADCs

Antibody-drug conjugates

Antibody-drug conjugates (ADCs) are transforming oncology treatment and 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.

The components required for the successful development of ADCs include Sterile fill-finish, lyophilization and specialist high-potency processing capabilities.

At PCI, our 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

In addition, our experienced analytical teams will ensure a successful development program. 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.

To complete our end-to-end service offering and driven by innovation and patient-centricity, our packaging design and development expertise, drug device final assembly, pack and test, and advanced drug delivery packaging capabilities offer flexible solutions for a diverse portfolio of conventional and specialty injectable drug products.

Lyophilization and Sterile Manufacturing Services

Our dedicated team of specialists will be happy to discuss any of our Sterile Manufacturing Services with you. Contact us on +1 215-613-3600 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com