Contract development and manufacturing organization
Accelerating new options for custromers and patients
Expert in developing your success
Radiochemistry Development
We offer development services as part of our full CDMO offering. We collaborate with you to develop an efficient process with the right degree of automation, scale, and controls for your stage in development.
Our development services include:
- Manufacturing Development
- Analytical Method Development
Manufacturing
We offer a one-stop-shop for early-stage clinical, late-stage clinical, and commercial manufacturing. Throughout your product’s lifecycle, our focus is on high quality, high reliability, and appropriate level scale-up. We manage the process from isotope sourcing to end customer delivery. We have commercial-scale production capacity built into our factory today and can expand further for project-specific needs.
Manufacturing
Early-Stage Manufacturing
- Phase I / II Clinical Trials
- Feasibility / Optimization of Radiolabeling
- Small Scale Manual Batches with Scale-Up and Automation Options
- Open Vial Filling
Late Stage and Commercial Supply Manufacturing
- Phase III / Commercial
- Process Robustness to Achieve Routine Supply
- Large Scale Automated Batches
- Open Vial Filling
Tech Transfer
DURING ALL DEVELOPMENT & MANUFACTURING STAGES (EARLY/LATE STAGE, COMMERCIAL SUPPLY), OUR SERVICES INCLUDE:
- Gap analysis and assessment of Tech Transfer Package
- Pilot to Engineering to Validation Phase
Quality Assurance
DURING ALL DEVELOPMENT & MANUFACTURING STAGES (EARLY/LATE STAGE, COMMERCIAL SUPPLY), OUR SERVICES INCLUDE:
- Operations and QMS in compliance with 21 CFR 211
- Deviations, Out-of-Specifications, Out-of-Trends, Risk Assessments, Equipment Qualifications, and Protocols
- Comprehensive Manual Batch Records with Planned Transition to Electronic Batch Records for Enhanced Efficiency
Quality Control
Early-Stage Manufacturing
- Analytical Method Development / Qualification
- Routine QC Testing. Stability Testing, In-House Sterility
- Environmental Monitoring
Late Stage and Commercial Supply Manufacturing
- Analytical Method Validation
- Routine QC Testing. Stability Testing, In-House Sterility
- Environmental Monitoring
Logistics
DURING ALL DEVELOPMENT & MANUFACTURING STAGES (EARLY/LATE STAGE, COMMERCIAL SUPPLY), OUR SERVICES INCLUDE:
- Packaging and global logistics coordination
- Direct ordering from end-users (e.g. hospitals, trial sites, academic centers)
- Store and segregate process-specific equipment and materials
- Isotope Supply Management
Alpha therapies
Evergreen has dedicated cleanroom facilities specifically for GMP manufacture of alpha-emitting radiopharmaceuticals, particularly using Ac-225, with capability of early clinical through commercial supply. As the centerpiece of this suite, Evergreen has installed a modular containment isolator, with allowances for scalable Ac-225 radiolabeling and dispensing operations.
Two Manufacturing Dispensing/Transfer Chambers
- Identical, ISO-5 laminar flow chambers for aseptic operations
- Integrated viable and non-viable particle monitoring
- Integrated VHP decontamination
Isotopes
The Springfield facility is licensed for commercial-scale quantities of a variety of diagnostic and therapeutic isotopes, including:
Diagnostic
- Cu-64
- Ga-68
- In-111
- Pb-203
- Zr-89
Therapeutic
- Ac-225
- At-211
- Cu-67
- I-131/I-124/I-123
- Lu-177
- Pb-212
- Tb-161
Project management
Each CDMO project is supported by an Evergreen project manager. The project manager leads the program through a well-defined tech transfer process.
Reasons to choose evergreen as your CDMO partner
Technical project management
Our project management team is comprised of technical personnel who build direct experience with your process. This streamlines communication and problem solving by eliminating gaps.
During the initial tech transfer stages of the project, Evergreen will provide a project plan, including a Gantt chart of activities, to accomplish the full scope of the tech transfer.
Our project management team is comprised of technical personnel who build direct experience with your process. This streamlines communication and problem solving by eliminating gaps.
During the initial tech transfer stages of the project, Evergreen will provide a project plan, including a Gantt chart of activities, to accomplish the full scope of the tech transfer.
State-of-the-art manufacturing facility
Scalability under one roof
The Springfield facility is designed to support the growth of your program from first-in-human doses to commercial supply. As volume demand increases, Evergreen experts can assist in scale-up and automation activities which transition the project to commercial production lines. The same project team remains involved and institutional project knowledge is preserved throughout.
Proficient in all phases of Actinium-225 drug development
Evergreen provides extensive experience in development and QC of actinium products. With a dedicated alpha line, we can provide end to end support from development through commercialization.
The Springfield facility is designed to support the growth of your program from first-in-human doses to commercial supply. As volume demand increases, Evergreen experts can assist in scale-up and automation activities which transition the project to commercial production lines. The same project team remains involved and institutional project knowledge is preserved throughout.
Proficient in all phases of Actinium-225 drug development
Evergreen provides extensive experience in development and QC of actinium products. With a dedicated alpha line, we can provide end to end support from development through commercialization.
Ideal location for just-in-time logistics
Evergreen’s location in Springfield, NJ is just 15 minutes from Newark International Airport (EWR), and easily accessible to/from John F Kennedy (JFK) and La Guardia (LGA) airports in New York and Philadelphia International Airport (PHL) in Pennsylvania.
This location is ideal for:
- Receiving incoming isotope shipments from global suppliers
- Well-positioned near large clinical research and academic flagship hospitals in the northeast of the US
- Same-day, just-in-time shipments of finished drug product to patient locations in the US and around the world
Evergreen’s location in Springfield, NJ is just 15 minutes from Newark International Airport (EWR), and easily accessible to/from John F Kennedy (JFK) and La Guardia (LGA) airports in New York and Philadelphia International Airport (PHL) in Pennsylvania.
This location is ideal for:
- Receiving incoming isotope shipments from global suppliers
- Well-positioned near large clinical research and academic flagship hospitals in the northeast of the US
- Same-day, just-in-time shipments of finished drug product to patient locations in the US and around the world
Therapeutic GMP compliance
Facility and Quality Management System were designed and built, from the ground up, to support global therapeutic GMP operation via compliance with 21 CFR 211 in the US and Annex 1 in Europe.
Facility and Quality Management System were designed and built, from the ground up, to support global therapeutic GMP operation via compliance with 21 CFR 211 in the US and Annex 1 in Europe.