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Chemical GMP Synthesis Facility

Chemical GMP Synthesis Facility
The Chemical GMP Synthesis Facility (CGSF) is a state-of-the-art manufacturing facility for small and large molecule therapeutics for clinical trials.The CGSF provides services for drug discovery, process research, development and early clinical manufacturing of pharmaceutical drug substances (APIs) that meet Food and Drug Administration requirements. With its significant capabilities, the CGSF plays a key role in bridging basic science and translational medicine at City of Hope. It is a key component within the Developmental Cancer Therapeutics Program. The facility is designed specifically to produce quantities of API on scales suitable for use in preclinical toxicology studies and phase I/II clinical trials.

Facilities Overview
The CGSF provides internal and external investigators with a regulatory compliant, cost effective route to bringing promising therapeutics to the clinic.

cGMP Grade API Manufacturing
The manufacturing suites are designed specifically to accommodate gram to kilogram production of cGMP-grade small molecule, biopolymer (peptides, siRNA-aptamers, DNA-peptide hybrids) and nano material APIs in support of phase I and II clinical trials. Adherence to cGMP (current good manufacturing practices) is essential in ensuring the quality and integrity of manufactured APIs.

Integrated Quality Control
Our on-site quality control unit is committed to providing excellence in service for the testing and release of manufactured APIs with strict adherence to requirements set forth by the Food and Drug Administration.

Chemistry Support
The CGSF is under the direction of Christopher Lincoln, Ph.D. who leads a team of synthetic and analytical chemists in providing an array of services and support in bringing benchtop discoveries to the clinic.These include:

 

Route selection and optimization Process development and scale-up Synthesis of GLP API for toxicology Synthesis and characterization of metabolites, impurities and reference standards
 

Facilities

The manufacturing facilities at the Chemical GMP Synthesis Facility are designed specifically to handle the synthesis of APIs for phase I and phase II clinical trials. The manufacturing rooms are organized into three isolated, independent suites. The organic synthesis labs are specifically equipped to handle multigram to kilogram (phase I) and multikilogram (phase II) small molecule projects. The RNA/oligonucleotide laboratory suite is designed to accomodate production of cGMP-grade biopolymers (siRNA-aptamers, DNA-peptide hybrids, peptides).
 
Phase I Laboratory
The Phase I suite is equipped with three 6-foot walk-in fume hoods. Reactions are carried out in dedicated Chemglass jacketed glass reactors, with capacities from 500 milliliters to 20 liters. Purifications are carried out using an automated Teledyne Isco Torrent purification system, allowing for quick and efficient isolation of intermediates and final products.
 
Phase II Laboratory
The Phase II suite is equipped with two 8-foot walk-in fume hoods. Reactions are carried out in dedicated Chemglass jacketed glass reactors, with capacities from 20 to 100 liters. Purifications are carried out on a Biotage Flash 150 system, allowing for quick and efficient isolation of intermediates and final products.
 
RNA/Oligo Laboratory
The RNA/oligo laboratory has the ability to be equipped with the necessary synthesizers and purification equipment suitable for API manufacturing. Drugs in this category will be synthesized as lyophilized powders and processed in our Packaging/Purification Room using a VirTis Genesis 25EL Pilot Lyophilizer.
 
Packaging/Purification Room
This room is dedicated to single product packaging prior to transfer of APIs for release testing and clinical use.
 
Stability/Storage Room
This room is equipped with Norlake ICH chambers, a Caron photostability chamber and controlled temperature storage (2-8ºC, -20ºC) for analysis of stability and bulk storage of API.

Manufacturing

The cGMP production laboratories at  theChemical GMP Synthesis Facility are focused on providing researchers with services for drug discovery, process research, development and early clinical manufacturing of pharmaceutical drug substances.

The design of the facility allows for three simultaneous processes to be performed, under cGMP in functionally isolated areas of the facility.

Our chemists specialize in the synthesis of complex small molecules and possess experience in both industrial and academic environments, with a broad range of synthetic capabilities and the knowledge of  the latest technologies and techniques.
 
Our secured, state-of-the-artfacility features:
 
  • Class 10,000 facilities for delivering intermediates and API for clinical applications
    • Gram to kilogram production runs
    • Glass jacketed reactors from0.5 liter to 100 liter capacities
    • Automated chromatographic equipment for purification
    • Key-card-restricted access
    • Provisions for N2 or other gases
    • Validated monitoring of all equipment, including HVAC
    • Quality control, quality assurance and product release, storage and management
       
  • Integrated quality control
    • Dedicated analytical laboratory
    • Equipped with qualified and validated instrumentation for the GLP/GMP release and characterization of APIs
 

Contract Services

The Chemical GMP Synthesis Facility can assist in the synthesis of intermediates by providing fully integrated GLP and GMP manufacturing services, while avoiding the high costs typically associated with commercial suppliers.
 
Internal expertise in:
 
  • Asymmetric Synthesis
  • Transition-metal Catalyzed Reactions
  • Low-temperature Reactions
  • Heterocyclic Chemistry

Synthetic processes that are designed to:
 
  • Optimize Yields
  • Decrease Cycle Times
  • Improve Process Scalability

GLP/GMP synthetic capabilities:
 
  • Manufacture of API raw materials and intermediates from gram to multikilogram scales
  • Manufacture of fine chemical raw materials and intermediates from gram to multikilogram scales
  • Synthesis of various compound classes
  • Reference compound synthesis
  • Purification to Food and Drug Administration standards

API manufacturing
 
Our chemists specialize in complex organic synthesis and possess experience in both industrial and academic environments. With extensive experience and a solid scientific background, our team has a broad range of synthetic organic chemistry capabilities, along with the knowledge of the latest techniques and technologies in purification to deliver an optimized product.
 
Services include:
 
  • cGMP manufacturing for preclinical and clinical APIs (phase I/II)
  • Gram to multikilogram synthesis
  • Manufacturing of APIs using supplied protocols or through custom synthetic routes designed to suit your needs
  • Batch record generation
  • Technical support and technology information exchange
  • CMC/DMF support for regulatory submissions
  • Rapid scale up of existing routes with aggressive timelines
  • Asymmetric synthesis, transition metal catalyzed reactions, low temperature and high pressure reactions and heterocyclic chemistry
 

Quality Control

The Quality Control (QC) laboratory directly adjacent to our Chemical GMP Synthesis Facility is overseen by an independent quality assurance manager.

Infrastructure:
 

  • Dedicated analytical laboratory
  • Equipped with qualified and validated instrumentation for the GLP/GMPrelease and characterization of APIs

QC Analysis of Intermediates, Drug Susbstances (DS) and CoA Release:
 
  • Identity
  • 1H-,13C-NMR
  • HRMS, MSn
  • UV-Vis spectroscopy
  • IR spectroscopy
  • Refractive index
  • Optical rotation
  • Melting point
     
  • Purity
    • Chemical purity
    • Related substances

       
  • Quality Tests
    • Heavy metals
    • Organic volatile impurities
    • Loss on drying
    • Residue on ignition
    • pKa determination
    • Raw materials release
       

Other Services:
 

  • Mass Spectrometry/NMR Spectrometry
    • Structural confirmation of API and intermediates
    • Structural determination of trace impurites
       
  • Release Testing for Oliogonucelotides/siRNA/Aptamers/Peptides
 
 

Pricing

Pricing is dependent on the nature of the project and will be determined based upon the scope of work. Please contact us for more information and a quote.
 
Why City of Hope?
City of Hope’s pioneering research has brought the world closer to cures for many life-threatening diseases, from cancer to diabetes.
 
Compassion drives our innovation. Every discovery we make and new treatment we develop gives patients the chance to live longer, better and more fully.
 
Comprehensive Cancer Center
In recognition of our excellence in a broad range of new approaches to cancer research and treatment—and our outreach to the community— the National Cancer Institute (NCI) has designated City of Hope a Comprehensive Cancer Center—one of just a handful of elite institutions nationwide.
 

Chemical GMP Synthesis Facility Team

Research Shared Services

City of Hope embodies the spirit of scientific collaboration by sharing services and core facilities with colleagues here and around the world.
 

Recognized nationwide for its innovative biomedical research, City of Hope's Beckman Research Institute is home to some of the most tenacious and creative minds in science.
City of Hope is one of only 41 Comprehensive Cancer Centers in the country, the highest designation awarded by the National Cancer Institute to institutions that lead the way in cancer research, treatment, prevention and professional education.
Learn more about City of Hope's institutional distinctions, breakthrough innovations and collaborations.
Support Our Research
By giving to City of Hope, you support breakthrough discoveries in laboratory research that translate into lifesaving treatments for patients with cancer and other serious diseases.
 
 
 
 
Media Inquiries/Social Media

For media inquiries contact:

Dominique Grignetti
800-888-5323
dgrignetti@coh.org

 

For sponsorships inquiries please contact:

Stefanie Sprester
213-241-7160
ssprester@coh.org

Christine Nassr
213-241-7112
cnassr@coh.org

 
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