Chemical GMP Synthesis
The Chemical GMP Synthesis Facility (CGSF) is designed for the manufacture of active pharmaceutical ingredients (API) for phase I and phase II clinical trials. The ISO 7 manufacturing facility is organized into four isolated, independent suites housing dedicated equipment for small molecule and RNA/DNA therapeutic manufacturing. Bulk API packaging, aseptic formulation/vialing and stability options are available for both RNA/DNA and small molecule therapeutics.
Recent efforts to expand capacity for RNA/DNA manufacturing have been achieved with the acquisition of the GE OligoPilot 400 synthesizer and GE AKTA Process purification system. This expansion allows for developmental manufacturing, as well as achieving quantities suitable for clinical supply.
Small molecule manufacturing is carried out in dedicated Chemglass jacketed glass reactors, with capacities from 500mL to 100 liters. Synthesized compounds are purified via flash chromatography using the automated Teledyne Isco Torrent purification system, allowing for quick and efficient isolation of intermediates and final products.
Using the Facilities
The cGMP production laboratories at the Chemical GMP Synthesis facility focus on providing researchers with services for drug discovery, process research, development, and early clinical manufacturing of pharmaceutical drug substances.
The facility's design 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 knowledge of the latest technologies and techniques.
Our secured, state-of-the-art facility features:
- Class 10,000 facilities for delivering intermediates and API for clinical applications
- Gram to kilogram production runs
- Glass jacketed reactors from 0.5-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 and GMP release and characterization of APIs
The CGSF provides services for several areas: drug discovery, process research, process development, and manufacturing of APIs.
GLP and GMP Synthetic Capabilities
- Fully equipped development labs
- Manufacture of API and fine chemical raw materials and intermediates
- Synthesis of various compound classes
- Reference compound synthesis
- Purification to FDA standards
- Aseptic Fill & Finish capabilities for parenteral preclinical and phase I and II products
API Manufacturing Services
- cGMP manufacturing for preclinical and clinical APIs (phase I and II)
- Gram to multikilogram synthesis
- Route optimization
- Batch record generation
- Technical support and technology transfer
- CMC and DMF
- Process development and scale-up
- Asymmetric synthesis, transition metal-catalyzed reactions, low-temperature reactions and heterocyclic chemistry
Meet the Team
Leadership
Core Staff
Stephanie Herman
Chemistry Associate III — Production
[email protected]
626-256-4673, ext. 84337
Piotr Swiderski, Ph.D.
Research Professor (Subject Matter Expert)
[email protected]
626-256-4673, ext. 65357
Rajiv Nallu
Quality Assurance Director
[email protected]
626-256-4673, ext. 85744
Josepha Jesuraj
Staff Scientist
[email protected]
626-256-4673, ext. 89116
Jose Pena
Senior Chemistry Associate — Quality Control
[email protected]
626-256-4673, ext. 89115
Gustavo Quintana
Chemistry Associate II —Quality Control
[email protected]
626-256-4673, ext. 89115
Augustin Yu
Quality Control Associate I
[email protected]
626-256-4673, ext. 89115
Naresh Genabai
Quality Assurance Associate III
[email protected]
626-256-4673, ext. 65731
Laura Ross
Quality Assurance Associate II
[email protected]
626-256-4673, ext. 87612
Contact the Team
Current pricing can be found on iLab Solutions.
Equipment
Semi-automated, tangential-flow filtration and cross-flow filtration system for the concentration and diafiltration of purified oligonucleotides
The Oligopilot Plus synthesizer is utilized for synthesizing quantities of oligonucleotides for development and early-stage toxicology studies.
AKTAprocess is an antomated liquid chromatography system built for process scale-up and large-scale biopharmaceutical manufacturing.
AKTA Pure is an antomated liquid chromatography system built for process development and small-scale biopharmaceutical manufacturing.
Used for the concentration, solvent recycling and drying of chemical intermediates
Chemical process reactors equipped with stir assembly and thermal controls
Allows for the custom configuration of freeze-dry cycles to accommodate a wide range of drug products and APIs
Provides in-process and release testing of chemical intermediates, APIs and drug products
The OligoPilot 400 is a synthesizer specifically developed to synthesize quantities for early clinical trials. This mid-range oligonucleotide synthesizer covers a range from 4mmol to 60mmol for the therapeutic oligonucleotide market.
In a given year, City of Hope conducts more than 400 clinical trials enrolling more than 6,000 patients.
City of Hope is focused on basic and clinical research in cancer, diabetes and other life-threatening diseases.
