Services

  • Radiochemistry Development

    Radiochemistry Development

    Understanding and optimizing your radiolabeling and analytical methods early sets you up for success down the road.

  • Early Stage Manufacturing

    Early Stage Manufacturing

    At an early stage, flexibility of operations and consistency of product are crucial.

  • Late Stage and Commercial Manufacturing

    Late Stage and Commercial Manufacturing

    At later stages, scalability and the highest standards of quality dominate the discussion.

  • Alpha Therapy Line

    Innovative manufacturing capabilities for development and scale-up of Alpha products.

 
 

 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.