The Discovery Labs is establishing THE COLONY which will provide custom built discovery labs, breakthrough funding, sponsored research agreements, housing and relocation for the world’s leading iconic experts in cell and gene therapy.
THE COLONY will seek to work hand in hand with scientists from both academic and pharmaceutical institutions to unlock and expedite groundbreaking therapies.
The ability for the industry’s greatest scientists to cohabitate, collaborate, cooperate, and communicate via technology and in person will create an exponential therapeutic “X FACTOR.” THE COLONY seeks to unlock institutional barriers prohibiting the world’s greatest scientists from moving at a pace necessary in today’s ever-changing therapeutic revolution. THE COLONY will partner with the institutions where the scientists currently work by providing equity, license fees, and revenue sharing.
The Discovery Labs Center for Breakthrough Medicines is a Contract Development and Manufacturing Organization (CDMO) whose mission is to accelerate the delivery and affordability of life-saving and life-changing therapies from the point of discovery at the bench to delivery to the patient by providing one source for process development, plasmid production, viral vector production, cell banking, and cell bioprocessing.
We are committed to enabling the future of cell and gene therapies on a one million square foot campus in the heart of the Cellicon Valley, King of Prussia / Philadelphia, PA.
Make The Discovery Labs your home…Unite. Discover. Manufacture. Breakthrough.
The Center for Breakthrough Medicines is a seamless multi-point tech transfer facility, enabling your research to safely transition in to our CDMO without risk or compromise.
Unite IQ, in partnership with Pennsylvania Biotechnology Center, and the Science University of Experiential Learning at The Discovery Labs is a place to learn, collaborate, present, discover, and grow.
One of the industry’s largest teams of process development scientists work side-by-side with the client’s subject matter experts to optimize upstream and downstream processes intended for robust cGMP manufacturing of viral vectors at appropriate scale, and the bioprocessing of autologous and allogeneic cellular therapies such as CAR-T cells, TILs, TCRs and regenerative medicine cellular products.
The Center for Breakthrough Medicines offers 10 research and GMP grade plasmid production suites with the manufacturing capacity and capability to fit the specifications of individual clients for pre-clinical, clinical and commercial scale production. Our complete array of plasmid manufacturing services provides every resource necessary to bring your project to a patient-ready product for vector development or gene editing. We can accommodate batch sizes from research to preclinical and GMP scale up to 2000L.
Adeno-associated viral (AAV) vectors play a central role in the delivery of gene therapies and as a vehicle for gene editing approaches such as CRISPR-Cas9. The Center for Breakthrough Medicines offers 20 production suites with a full range of AAV production scales and platforms to serve the research, preclinical, clinical and commercial manufacturing demands for these vectors. Viral packaging at small scale using transient transfection of HEK 293 cells in either adherent or suspension platforms is available for discovery research, proof of concept, and early clinical manufacturing. Large-scale production in single-use bioreactors is available utilizing transient transfection of HEK 293 cells or HeLa cells utilizing a helper virus. A proprietary cell line and optimized transfection conditions are employed to ensure high titres of AAV for many of the commonly utilized AAV serotypes. Additionally, Baculovirus-based production of AAV utilizing insect cell culture (Sf9 cells) is available for use in large scale production. Process optimization is undertaken to determine the best conditions for manufacturing of the client-specific vector and gene of interest in all platforms. Downstream purification processing with large scale column chromatography ensures that vector product yields and purity are optimized to meet the stringent quality standards anticipated by U.S. and international regulatory agencies.
Lentiviral and retroviral vectors, by virtue of their relatively large payload capacity and the capability to transfect dividing and non-dividing cells are at the forefront of CAR-T cell development and may also serve as stand-alone vectors for gene therapy. 20 production suites provide available platforms for production of lentiviral vectors including the transfection of 293T cells in adherent culture (CellStacks or HyperStacks) with larger-scale, closed-system manufacturing utilizing a proprietary producer line in suspension culture with single-use bioreactors for production. Production scales range from 10L up to 2,000L. Media and cell culture optimization are undertaken to ensure high yields. Downstream processing consists of filtration, chromatographic purification and sterile filtration to ensure for the removal of process contaminants and residuals. In addition to large-scale downstream processing equipment, harvest optimization and cryopreservative formulation development are available to optimize the infectious titre of the vector.
Through the Center for Breakthrough Medicines’ dedication to quality and our expertise, we provide the flexibility of multiple GMP Adenovirus production strategies to produce high titre adenovirus for gene therapy projects or for use as potential oncolytic viral agent. Process development and manufacturing resources are available in 20 production suites to meet your individual needs, providing the integrated resources necessary to bring your project to clinical reality in an efficient and expedient manner.
The Center for Breakthrough Medicines at The Discovery Labs is a seamless multi-point tech transfer facility, enabling your research to safely transition into our CDMO without risk or compromise. We provide process development, manufacturing, pharma-quality laboratories and offices for advanced therapies companies.
The Center for Breakthrough Medicines supplies clients with large-scale capacity to manufacture Master Cell Banks (MCB), Working Cell Banks (WCB), Master Viral Banks (MVB), and Working Viral Banks (WVB). This manufacturing process meets global cGMP regulatory standards and guidelines to guarantee research and clinical grade production. Our cell banking team is capable of producing up to 1,000-vial cell banks in cGMP-compliant suites. Standard release criteria support documentation such as viability and sterility are provided with our services.
The Center for Breakthrough Medicines offers experienced staff and 36 flexible manufacturing suites to accommodate innovative advanced therapies workflows and equipment configurations. For autologous products, we employ the most sophisticated scheduling, supply chain and inventory control, in-process testing, quality control, and lot release systems on the market to overcome the inherent manufacturing challenges. Many cell therapy products are composed of ex-vivo patient derived starting materials which create variation in the clinical development pathway for these products. The Center for Breakthrough Medicines offers flexibility in the unit operations and procedures required to accommodate these products on a client-specific basis. For allogeneic products, manufacturing operations employing well-characterized cell banks may be scaled-up to meet the clinical and commercial demand employing both adherent systems (e.g. CellSTACKS®, HYPERStacks®) as well as single-use bioreactors for production of cell products at significant scale. These collective resources permit the progress of cell therapy manufacturing from clinical to commercial within a single facility without time lost in technology transfer from site to site.
Our manufacturing capabilities include but are not limited to the following:
To complement manufacturing operations, The Center for Breakthrough Medicines provides extensive laboratories and qualified/validated methods for the analysis of plasmid DNA, viral vectors and cellular therapies. Analytical method development in parallel with process development and technology transfer activities is required to provide the most rapid progress of GMP manufacturing programs. Methodologies optimized in analytical development are transferred upon successful completion to established core testing laboratories (flow cytometry, molecular biology,biochemistry, biosafety, etc.) for routine application in the in-process and quality control lot release required for disposition of the final plasmid, vector or cell therapy product.
Located in the heart of the Cellicon Valley, where cell and gene therapy was invented. 1.6 million square feet of CDMO, research and development, administrative offices, dining, daycare, and fitness amenities. Each building is connected by internal floor to ceiling glass corridors and separated by indoor and outdoor atriums providing world-class, employee-centric, inspirational, collaborative space needed to recruit and retain the finest talent. Our site is capable of adding up to 4 million square feet of expansion space to accommodate every growing need of our clients ON LOCATION. Our 640,000 Square foot Innovation Renaissance campus provides build-out and collaboration opportunities and is currently occupied by the finest life science organizations in the world. Our entire campus is supported by an extensive array of infrastructure which provides 100% backed-up systems. Most importantly our campus is IN PLACE TODAY ready to be customized for your specific needs.
