Lyophilization Services of New England
PCI Pharma Services is a global leader in pharmaceutical development, manufacturing, and packaging services. With over five decades of experience and more than 90 successful product launches each year, PCI is committed to delivering better health outcomes through innovative solutions, speed, and quality. The company operates in North America, Europe, and Asia Pacific, with 30 GMP facilities and a dedicated workforce of over 6,000 employees. PCI offers a comprehensive range of services including drug development, sterile fill-finish, lyophilization, high potent manufacturing, clinical trial services, advanced drug delivery, and commercial packaging. Their mission is to support clients from early-stage development through commercialization and beyond, ensuring regulatory compliance and operational excellence.
Industries
Nr. of Employees
medium (51-250)
Lyophilization Services of New England
3001 Red Lion Road, Philadelphia, PA, 19114, USA
Products
Supply chain management platform
Cloud-based platform providing real-time visibility of supply chain inventory, coordination and forecasting across clinical and commercial life cycles.
Microdosing early-phase manufacturing workflows
Microdosing approaches and manufacturing workflows to accelerate first-in-human dosing while reducing formulation development time and API usage.
Clinical supply readiness platform and early-dose program
Programmatic and platform services to manage clinical supply readiness for early human dosing, including project coordination, regulatory milestone tracking and supply planning.
Supply chain management platform
Cloud-based platform providing real-time visibility of supply chain inventory, coordination and forecasting across clinical and commercial life cycles.
Microdosing early-phase manufacturing workflows
Microdosing approaches and manufacturing workflows to accelerate first-in-human dosing while reducing formulation development time and API usage.
Clinical supply readiness platform and early-dose program
Programmatic and platform services to manage clinical supply readiness for early human dosing, including project coordination, regulatory milestone tracking and supply planning.
Services
End-to-end pharmaceutical development and GMP manufacturing for investigational and commercial products across multiple dosage forms, including high-potency and biologic modalities.
Services supporting targeted modalities including antibody–drug conjugates: process and formulation development, high-potency handling, lyophilization and temperature-controlled packaging and distribution.
Clinical-stage manufacturing, packaging, labeling, storage, distribution and supply management for trials, supported by QP oversight and clinical support services.
Design, development, final assembly, pack & test, and advanced packaging for combination products and next-generation injectable delivery formats.
Primary and secondary commercial packaging services, packaging design, serialization, anti-counterfeiting and launch support across global markets.
Integrated services to accelerate development and commercialization including NPI, technical transfer, demand modeling, supply readiness and early-phase acceleration programs.
End-to-end pharmaceutical development and GMP manufacturing for investigational and commercial products across multiple dosage forms, including high-potency and biologic modalities.
Services supporting targeted modalities including antibody–drug conjugates: process and formulation development, high-potency handling, lyophilization and temperature-controlled packaging and distribution.
Clinical-stage manufacturing, packaging, labeling, storage, distribution and supply management for trials, supported by QP oversight and clinical support services.
Design, development, final assembly, pack & test, and advanced packaging for combination products and next-generation injectable delivery formats.
Primary and secondary commercial packaging services, packaging design, serialization, anti-counterfeiting and launch support across global markets.
Integrated services to accelerate development and commercialization including NPI, technical transfer, demand modeling, supply readiness and early-phase acceleration programs.
Expertise Areas
- Sterile fill–finish and lyophilization
- High-potency processing and containment
- Formulation development using Quality by Design
- Analytical method development and GMP release testing
Key Technologies
- Lyophilization (freeze-drying)
- Aseptic fill–finish automation and robotic filling
- Containment systems for high-potency processing
- Microdosing workflows (direct-in-capsule, drug-in-vial)
News & Updates
An article discussing innovations in sterile fill-finish manufacturing.
An article on the impact of targeted protein degraders in therapeutics.
Insights into manufacturing processes for drug-device combination products.
A discussion on strategic approaches in complex drug development.
An article on innovations in sterile manufacturing.
An article on targeted protein degraders.
An article discussing innovations in sterile fill-finish manufacturing.
An article on the impact of targeted protein degraders in therapeutics.
Insights into manufacturing processes for drug-device combination products.
A discussion on strategic approaches in complex drug development.
An article on innovations in sterile manufacturing.
An article on targeted protein degraders.