Services
Chemistry Development
We take the Development aspect of CDMO seriously. We work with you collaboratively, to develop an efficient process with the right degree of automation, scale, and controls for your stage in development. We are your partner in the process and will provide active input and support. We have a wide range of technical development expertise, including particular specialization in automation of production for antibody-based radiopharmaceuticals. Our development services include the following:
Process Development
Small-scale conjugation development
Optimization of radiolabeling conditions
Purification and elution profile optimization
Scale-up and automation of manufacturing and dispensing
Formulation and radiostabilizer optimization
Analytical Method Development
HPLC, TLC, GC
Gamma Spectroscopy
pH and Visual Inspection
Radioimmunoassay (bead-based)
Quality and Process Development
SOP / Batch Record Generation
Preliminary Risk Assessment
Development / Engineering / Validation Reporting
Early Stage Manufacturing
For early stage manufacturing, it’s important to implement the right degree of controls, while maintaining flexibility to meet your clinical trials needs efficiently. We oversee the following processes and communicate through a dedicated project manager:
Manufacturing for Phase 1 / 2 Trials
Feasibility studies and engineering runs
Analytical method qualification and validation
Radiolabeling and dispensing process validation
Tech Transfer & Validation
Manual radiolabeling capabilities
Closed vial fill and dispensing
Routine QC testing and environmental monitoring
Late Stage Manufacturing
For late stage and commercial production, our focus is on high quality, high reliability, and scale. Our quality system is designed to 21 CFR 211 and global standards. Our approach to reliability comes from years of experience launching and manufacturing radiopharmaceuticals using a variety of isotopes for delivery locally or nationwide. We manage the process from isotope sourcing to end customer delivery, because often logistics reliability is as important as manufacturing reliability. We also have commercial scale production capacity built into our factory today, and can expand further for project-specific needs. Our late stage and commercial services include:
Manufacturing for Phase 3 and commercial products
Automated radiolabeling procedures
Open vial fill and dispensing
Operations and QMS in compliance with 21 CFR 211
Packaging and logistics coordination, including direct ordering from end-users
Isotope supply management
Alpha Therapy Line
Evergreen has dedicated a cleanroom suite 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. The isolator, manufactured and qualified by Tema Sinergie, was installed in Springfield and commissioned in Q1 2023, and features the following components:
Two material pre-chambers
One on each end of the line
Could be used as entry/exit for smaller operations or could work left-to-right with dedicated entry and exit for larger-scale production
Continuous liner ports and bag welder for controlled waste removal
Two manufacturing/dispensing chambers
Identical, ISO-5 laminar flow chambers for aseptic operations in a controlled environment
Unidirectional flow
Integrated viable and non-viable particle monitoring
Negative pressurization with respect to the cleanroom suite
Sliding lead-glass window for operator shielding
Bag in/bag out HEPA and charcoal filters in exhaust stream
Integrated VPHP decontamination
Evergreen aims to centralize alpha operations within this suite as much as possible, and has additional space to add equipment for other specialized operations.