All posts by driftdev
G-CON Supplies the Cleanroom Infrastructure for CytoImmune Therapeutics, Inc.
G-CON, the leader in prefabricated, flexible cleanroom solutions, recently supplied the cleanroom infrastructure for CytoImmune Therapeutics, Inc. (CytoImmune), a clinical-stage immunotherapy company that is developing a novel class of engineered natural killer (NK) cell-based cancer therapies. G-CON PODs were built in College Station and have been shipped and integrated into CytoImmune’s custom-designed facility. The project was G-CON’s first in Puerto Rico.
“We were able to start our first shakedown cell therapy run six months after choosing our facility,” stated William Rosellini, Co-Founder and President of CytoImmune. “Our team of experts at OcyonBio chose G-CON, who provided us with access to a wealth of technology and expertise right from the start. We believe the partnership reduced the time to our IND filling for our lead program by over a year.”
“G-CON is honored having worked with CytoImmune, and partner Biosciences, to rapidly deliver this facility for the development and manufacture of NK Cells,” stated Tim Vickers, Executive Director of Business Development at G-CON. “G-CON’s cell therapy catalogue allowed CytoImmune to select a pre-designed layout that resulted in a rapid delivery to the Puerto Rico site.”
CytoImmune announced in March the opening of its Toa Baja clinical cell manufacturing facility. The POD layout and design for the cleanroom infrastructure was selected from G-CON’s Cell Therapy Catalog, allowing a timeline of nine months from start of design to factory acceptance testing (FAT).
About G-CON
G-CON is fulfilling the needs of reliable and fast deliverable capacities for the biopharmaceutical industry. G-CON provides comprehensive prefabricated and prequalified CGMP compliant cleanroom environments and platforms for uses ranging from laboratory, clinical and commercial production for a variety of therapeutic applications.
Through a well-defined customer needs driven approach to design, production, installation and qualification, G-CON provides a fully functional cleanroom product portfolio enabling reliable biocapacity planning on-time and within-budget. For more information, please visit G-CON’s website at http://www.gconbio.com
.
About CytoImmune Therapeutics, Inc.
CytoImmune Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to utilize the power of the engineered cells to activate the patient’s immune system to eliminate cancer cells. The company is advancing a differentiated pipeline of off-the-shelf NK cell therapies, using proprietary, robust and well characterized NK cell expansion and engineering technologies that are designed to provide effector cell therapy with broad immune stimulation, to enable effective tumor killing in both solid tumors and hematologic malignancies. For more information, please visit Cytoimmune.com.
Pre-Use/Post Sterilization Integrity Testing Results of the SFQRM Work
G-CON Expands Its Product Portfolio with the Acquisition of Panelco / Plasteurop SAS, a Leading Cleanroom Component Manufacturer
G-CON Manufacturing, Inc. has acquired Plasteurop, a leading France-based manufacturer of critical cleanroom components. Plasteurop’s core competence is the automated production of monolithic cleanroom wall panels and doors. These components are used in a variety of industries with stringent standards for cleanliness and quality. Plasteurop was founded in 1978 and acquired by Panelco SAS in 2004. Since then, the company has produced numerous highly innovative products and has received multiple awards for innovations in the cleanroom infrastructure market.
“We have enjoyed working with Plasteurop on many projects and have been impressed by their robust delivery timelines and high quality of the supplied components,” stated Maik Jornitz, President and CEO of G-CON. “This acquisition is a natural progression, adding these critical components into our product portfolio so we are able to serve our customer base with a broader range of bioprocess space infrastructures. The vertical integration of these cleanroom components will also accelerate our already rapid delivery times and enhance the delivery schedule certainty, all to the benefit of the global patient.”
Plasteurop will become G-CON Clean Components SAS, with Philippe Calland remaining as the President of the independent subsidiary.
“Our desire is to accelerate the growth and further the innovative power of Panelco by joining G-CON, which we see as industry transforming prefabricated cleanroom supplier. The joint vision and values of the companies and combined product portfolio will advance our market leadership as total cleanroom infrastructure provider,” said Philippe Calland, President of Panelco. “This enables us to deliver sustainable healthcare processing spaces faster and in a much more cost-effective way.”
About G-CON Manufacturing, Inc.
G-CON Manufacturing designs, builds and installs prefabricated G-CON POD® cleanrooms. G-CON’s POD portfolio provides cleanrooms in a number of dimensions for a variety of uses, from laboratory environments to personalized medicine and production process platforms. G-CON POD® cleanroom units surpass traditional cleanroom structures in scalability, mobility and the possibility of repurposing the PODs once the production process reaches its lifecycle end. For more information, please visit G-CON’s website at http://www.gconbio.com. G-CON Manufacturing… BUILDING FOR LIFE™
About Panelco SAS
Panelco founded in 1978 and based in Vonnas near Lyon (France) is a leader in manufacturing of high-quality cleanroom wall and ceiling panels, windows and doors. Panelco supplies a variety of European cleanroom installers serving different types of industries with a wide variety of innovative cleanroom components.
For more information, please visit http://www.plasteurop.com
G-CON standardPOD Cleanrooms, Now Available in Europe
The off-the-shelf cleanroom design is available immediately across the EMEA market with delivery to clients in 3 months or less.
KILKENNY, Ireland, March 8, 2022 /PRNewswire/ — G-CON, the leader in off-site prefabricated, flexible cleanroom solutions, today announced its capabilities to manufacture and deliver the company’s signature standardPOD cleanrooms in Europe. standardPODs, launched in the U.S. in 2020, are off-the-shelf cleanrooms designed to maximise efficiencies related to production, qualification, delivery and cost reduction and provide timeline certainty to drug manufacturing.
G-CON’s standardPOD portfolio encompasses six PODs, three different dimensions with bi-directional and uni-directional flow approaches and all featuring ISO 7 classification. These units can ably support development and clinical scale operations for cell therapies, formulation and filling, drug substance, etc. and also be components of a building block approach for a multiple unit POD cluster to accommodate larger processing needs.
PODs, which have gained accelerating popularity over the past 12 years due to their prefabricated and prequalified turnkey benefits, are now readily available for the EMEA market through the standardPOD product line. With standardisation, these cleanrooms can be purchased at a set price, inclusive of design and qualification. G-CON’s standardized approach reduces the engineering design and fabrication timelines through process driven manufacturing with standard parts from qualified vendors and by employing a trained and experienced workforce. Commissioning and qualification are also well-defined, allowing for delivery in as little as three months from order.
“G-CON continues to expand its global product portfolio of pre-engineered standardPODs to help further reduce the time and cost for installing the highest quality cGMP cleanroom infrastructure for its clients”, stated Dennis Powers, Vice President of Business Development & Design Consulting for G-CON. “Standardization will drive efficiencies as the industry increasingly adopts pre-fabricated modular construction.”
Click here to request a copy of G-CON’s standardPOD Catalogue.
About G-CON
G-CON is fulfilling the needs of reliable and fast deliverable capacities for the biopharmaceutical industry. G-CON provides comprehensive prefabricated and prequalified CGMP compliant cleanroom environments and platforms for uses ranging from laboratory, clinical and commercial production for a variety of therapeutic applications.
Through a well-defined customer need driven approach to design, production, installation and qualification, G-CON provides a fully functional cleanroom product portfolio enabling reliable biocapacity planning on-time and within-budget. For more information, please visit G-CON’s website at http://www.gconbio.com.
G-CON Launches Predesigned Viral Vector POD Cleanroom Infrastructures
G-CON, the leader in off-site prefabricated, flexible cleanroom solutions, today launched its line of Viral Vector cleanroom infrastructure options, offering customers predesigned layouts to abbreviate design timelines and provide reliable budget and delivery timeframes. These processing space platforms have been designed based on G-CON’s deep experience in the space while leveraging its large installed base of prefabricated cleanroom PODs.
The creation of G-CON’s Viral Vector POD Designs are intended to meet the needs of viral vector processing and to support the forecasted rapid growth of cell and gene therapy manufacturing capacity needs. Using a predesigned approach, G-CON reduces design, build and qualification phases from years down to months. With G-CON’s new Viral Vector POD Catalog, designs are ready and useable, ranging from Small Scale AAV to Ballroom Based Viral Vector Systems. These designs also can be cloned for multi-site production, further reducing costs, time and resource consumption.
“When kicking off project discussions with a client, we leverage our project experience in providing their core area designs,” stated Peter Makowenskyj, Director of Design Consulting. “With our latest catalog, we can provide that context to our viral vector clients and rather than starting from scratch, starting with a vetted design that will lead to faster POD production and faster product production for the client as well.”
Click here to request a copy of G-CON’s Viral Vector POD Catalog.
About G-CON
G-CON is fulfilling the needs of reliable and fast deliverable capacities for the biopharmaceutical industry. G-CON provides comprehensive prefabricated and prequalified CGMP compliant cleanroom environments and platforms for uses ranging from laboratory, clinical and commercial production for a variety of therapeutic applications.
Through a well-defined customer need driven approach to design, production, installation and qualification, G-CON provides a fully functional cleanroom product portfolio enabling reliable biocapacity planning on-time and within-budget. For more information, please visit G-CON’s website at http://www.gconbio.com.
G-CON Selected to Supply the Cleanroom Infrastructure for TrueBinding, Inc.
College Station, TX – G-CON, the leader in prefabricated, flexible cleanroom solutions, announced today that it has been selected to supply the cleanroom infrastructure for TrueBinding, Inc. (TrueBinding), an early stage biotherapeutics development company focused on creating molecules for applications in immuno-oncology and other disease areas with unmet medical needs.
G-CON will provide the engineering design, build and delivery of prefabricated cleanroom PODs totaling a 3,000 sq. ft. footprint. The POD system will consist of four PODs for upstream/downstream processing, post viral and media/buffer prep. The design will also feature built-in corridors along with material airlocks and personnel airlocks. Each POD is designed with dedicated air handling units, a fire protection system, an integrated automation system, and process utility distribution. G-CON will commission the units after delivery as part of the overall project validation effort.
“We are thrilled to have been selected by True Binding for this project after they were referred to us by another G-CON client,” stated Tim Rasmussen, Design Consultant for G-CON. “TrueBinding has an aggressive timeline and PODs are ideal for meeting such a compressed schedule, especially in high construction demand regions like the bay area. We look forward to adding this project to our portfolio.”
“G-CON has been an important partner in designing and constructing the manufacturing spaces we need to produce our novel molecules. By meeting our accelerated timelines, G-CON has given us the ability to deliver life changing therapeutics to patients quicker. The team we have worked with, as well as the PODs themselves, have exceeded our expectations.” Maksym Tsvetkov, Production Manager for TrueBinding.
About G-CON
G-CON is fulfilling the needs of reliable and fast deliverable capacities for the biopharmaceutical industry. G-CON provides comprehensive prefabricated and prequalified CGMP compliant cleanroom environments and platforms for uses ranging from laboratory, clinical and commercial production for a variety of therapeutic applications.
Through a well-defined customer needs driven approach to design, production, installation and qualification, G-CON provides a fully functional cleanroom product portfolio enabling reliable biocapacity planning on-time and within-budget. For more information, please visit G-CON’s website at http://www.gconbio.com.
About TrueBinding, Inc.
TrueBinding Inc. is an early stage biotherapeutics development company focused on creating molecules for applications in immuno-oncology and other disease areas with unmet medical needs, such as neurological disorders and neurodegenerative diseases. TrueBinding has discovered novel, uncharacterized ligands to receptors of known checkpoint inhibitor pathways for potential therapeutic development. For more information, please visit https://www.truebinding.com/.
G-CON Expanding with an Additional 144,000 Square Foot Facility for POD Manufacturing
G-CON, the leader in prefabricated cleanroom solutions, today announced another facility expansion, increasing its U.S. based cleanroom construction site from 252,900 sq. ft. to 396,900 sq. ft. The new expansion will allow G-CON to achieve its US demand forecast for 2025. The building will be dedicated to the production of our G-CON’s Standard POD portfolio and the assembly of kitted components within the PODs, allowing the company to provide its growing client base with the benefits of off-site cleanroom construction.
“Standard PODs reduce engineering hours and time to delivery,” stated Blake Williams, Vice President of Manufacturing for G-CON. “In addition, the dedicated space for kitted components will further G-CON’s speed and efficiency in delivering prefabricated PODs. Both efforts will advance our primary goal of serving more patients.”
G-CON broke ground on the facility in June 2021. The structure will be completed June 2022 and fully operational in the third quarter of 2022.
About G-CON Manufacturing
G-CON is fulfilling the needs of reliable and fast deliverable capacities for the biopharmaceutical industry. G-CON provides comprehensive prefabricated and prequalified CGMP compliant cleanroom environments and platforms for uses ranging from laboratory, clinical and commercial production for a variety of therapeutic applications.
Through a well-defined customer needs driven approach to design, production, installation and qualification, G-CON provides a fully functional cleanroom product portfolio enabling reliable biocapacity planning on-time and within budget.
For more information, please visit G-CON’s website at http://www.gconbio.com.
G-CON Honored with the Europe Bioprocessing Excellence Award 2021
IMAPAC, the organizing committee of the Europe Bioprocessing Excellence Awards 2021 awarded G-CON with the 2021 Europe Bioprocessing Excellence Award for Best Bioprocessing Supplier in Engineering and Facility Design. The award recognizes industry leaders and pioneers in the bioprocessing industry who facilitate biomanufacturing excellence at enhanced speed, reduced cost and superior quality all across Europe and the rest of the world. G-CON is honored to be in the company of the fellow nominees and the many distinguished organizations and individuals who have been considered for this award in the past.
“We are very proud and recognize this award as a sign of the continued validation of G-CON’s efforts within the industry,” stated Dennis Powers, Vice President of Business Development & Design Consulting. “We would like to thank IMAPAC and the esteemed panel of judges for recognizing our contribution to the industry, our POD cleanroom technology, and our passion for driving innovation and change. Our goal from the beginning has been to help drug manufacturers implement new facilities and biocapacity faster and more cost effectively than ever before. Our team is fully committed to continue our work with industry leading suppliers and service providers to advance prefabricated modular manufacturing in order to enhance speed and flexibility, reduce costs, while maintaining the highest standards of excellence for new biomanufacturing facilities. All of with the focused common mission we all have to help save and improve patients’ lives.”
About G-CON Manufacturing
G-CON is fulfilling the needs of reliable and fast deliverable capacities for the biopharmaceutical industry. G-CON provides comprehensive prefabricated and prequalified CGMP compliant cleanroom environments and platforms for uses ranging from laboratory, clinical and commercial production for a variety of therapeutic applications.
Through a well-defined customer needs driven approach to design, production, installation and qualification, G-CON provides a fully functional cleanroom product portfolio enabling reliable biocapacity planning on-time and within-budget. For more information, please visit G-CON’s website at http://www.gconbio.com