G-CON understands the needs of the pharmaceutical industry and with its multi-disciplinary team can provide unparalleled products and services to it. Since our inception, we have provided autonomous cleanroom PODs for a number of needs.
G-CON delivered, in 8 months, multiple prefabricated cleanrooms to Rubius Therapeutics’ cGMP Facility, meeting ann aggressive timeline and providing speed to market for clinical manufacturing. Read More
In late 2018, the iCON team of IPS-Integrated Project Services LLC, GCON Manufacturing and GCON’s EU fabrication partner, Asgard Cleanrooms, began working with a global pharmaceutical company whose goal was to establish internal clinical viral vector production capability in Europe to support their rapidly expanding ATMP platform. After careful consideration of different construction approaches and the assessment of multiple sites, an iCON hybrid construction solution with PODs and modular cleanrooms was selected for installation in an existing building within their manufacturing network. This decision was largely driven by project schedule and the benefits of taking a pre-fabricated modular construction approach. This case study outlines the challenges, execution, and delivery of an iCON project. Read More
In February 2019, Merck, known as MSD outside the United States and Canada, chose G-CON’s POD® technology for the Merck Research Laboratories’ FLEx Center, to be located within the Rahway research campus. Construction will provide improved flexibility in pharmaceutical formulation and process development for sterile and oral solid-dosage products. Read More
GenCure selected G-CON for its new multi-product cell therapy facility. The new facility expandS GenCure’s manufacturing capabilities, providing new state of the art manufacturing capabilities to support clinical cell therapy trials. The PODs provide approximately 6,700 sqft. of cleanroom space to facilitate production of the large numbers of consistent, high-quality, clinical-grade adult stem cells needed to help bring potential new therapies into human clinical trials. Read More
PODs provide the environments for the entire upstream and downstream process for AveXis, a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases. The PODs form the Upstream, Downstream, and Filling unit operations as well as labs, connecting corridors and material air locks. The clean room classifications of the PODs include ISO 8/Grade D and ISO 7/Grade C spaces, Grade B spaces, and ISO 5/Grade A classifications. Read More
Portable. Continuous. Miniature. Modular. PCMM is a manufacturing collaboration among GEA Process Engineering, G-CON Manufacturing and Pfizer, providing the next generation of oral solid dose (OSD) process technologies to address the rapidly changing requirements of pharmaceutical development and manufacturing. PCMM integrates small footprint, continuous/semi-continuous processing equipment, smart control systems and PODs to process active pharmaceutical ingredient (API) powders and inactive ingredients through to bulk tablets or capsules.
HJB, a company formed to significantly reduce the cost of biologics to make them more accessible to a global population, employed prefabricated cleanroom PODs to achieve a flexible, rapidly deployable and efficient design that creates a new standard for bioprocessing industry facilities. Read More
UTHSC expanded the capabilities of the UTHSC Plough Center for Sterile Drug Delivery using G-CON PODs. PODs provide approximately 1800 sq. ft. of cleanroom space and incorporate areas for component preparation, compounding/formulation, filling and lyophilization for use in the manufacturing of clinical and small-scale products. Additionally, PODs provide approximately 760 sq. ft. of cleanroom space for the manufacturing and development of semi-solid products. Read More
This prefabricated cleanroom POD was built to satisfy the required cleanroom capacity on an accelerated time frame for Lonza's manufacturing of its virally modified cell therapy products in Houston, TX. Read More
Instituto Butantan is a biomedical research center located in Sao Paulo, Brazil. G-CON Manufacturing was selected to build an ISO 5 prefabricated cleanroom POD for use in the clinical production of recombinant BCG, a product intended to be an improved treatment for bladder cancer. Read More