Our mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to commercialization by providing one source for process development, plasmid and viral vector production, analytical testing, cell bioprocessing, platform IP, and the space to operate.
The Only Complete Solution for the Discovery, Development, and Commercialization of Cell and Gene Therapies.
30 CELL THERAPY SUITES
10 VIRAL VECTOR LINES
10 PLASMID SUITES
2 CELL BANKING SUITES
20 TESTING SUITES
20 PROCESS AND ANALYTICAL DEVELOPMENT SUITES
Our Mission
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.
What Makes Us Different
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.
- The Discovery Labs Center for Breakthrough Medicines provides instant capacity as the largest and most advanced, single-source for pre-clinical through commercial manufacturing in cell and gene therapy on one campus.
- We collaborate with the premier scientists in industry and academia to ensure that we are providing the foremost innovation for our customers and the patients they treat.
- Focused on reducing the time, complexity, and cost of the commercialization of lifesaving and life-changing cell therapies and viral vectors, making cures to diseases and genetic disorders scalable, affordable, and readily available to the patients who need them.
- We provide end-to-end management of your therapeutic manufacturing, allowing your organization to continue the focused pursuit of groundbreaking therapies.
- We offer clients cGMP compliant development, manufacturing, and testing services by recruiting and retaining the finest applied research, development, and manufacturing science and technology (MS&T) talent in the world to drive discovery, innovation, and timely execution.
- Our cell therapy processing and viral vector suites are fully compliant with FDA and EMA standards.
- We offer the latest cutting edge equipment, custom calibrated to meet your quality specifications and all compliance requirements.
- Our cleanrooms offer flexibility to meet various client-specific workflows and equipment configurations.
- The Center for Breakthrough Medicines is committed to manufacturing new therapies under cGMP conditions and the safe, ethical management of the patient as they progress through first in human trials.
- The Center for Breakthrough Medicines incorporates traditional Contract Research Organization (CRO) services with Contract Development Manufacturing Organization services under one umbrella to bring a highly differentiated offering to the marketplace.
- Our contract research services provide the full scope of clinical trial management needs to effectively recruit and treat patients.
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.
- Unite IQ offers immediate space to emerging biotech companies with the ability to graduate from a startup to enterprise company on one campus. Whether you are two scientists and a bench, a visiting professor from out of town, or a growing Life Sciences company, our incubator and accelerator space at Unite IQ provides you a comprehensive home with every resource needed to operate your business.
- Unite IQ hosts the Science University of Experiential Learning where we partner with high schools, colleges and universities to create the highly-skilled workforce of tomorrow needed to supply the demand of this exploding industry.
- Unite IQ provides research and development laboratories, shared equipment resources, on-site supplies, grant writing and submission services, business planning, and a showcase for financial capital providers associated with The Discovery Labs.
- Unite IQ tenants utilize the development, testing, and manufacturing capabilities of the Center for Breakthrough Medicines with seamless forward integration of processes and analytics.
- The Discovery Labs provides a fully-zoned, fully-equipped research facility to conduct preclinical studies with research models.
- We provide curated programming, events and the ability to connect, collaborate, and unite across the Discovery Labs network in the Unite IQ conference center and auditorium with fully-catered meeting and presentation space for up to 1,000 people.
Come Discover With Us
THE COLONY
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.
Process Development
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.
Analytical Method Development and Testing
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.
Plasmid DNA
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 Virus
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.
Lentivirus
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.
Adenovirus
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.
Cell Banking
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.
Cell Processing
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:
- Autologous and Allogeneic CAR-T cells
- Tumor infiltrating lymphocytes (TILs)
- Enhanced T-Cell receptors (TCRs)
- Stem cell therapies and induced pluripotent stem cells (iPSCs)
- Tumor cell vaccines
- Dendritic cell and NK cell adoptive Immunotherapies
Contract Research Services and Clinical Trials Management
The Center for Breakthrough Medicines contract research package provides support for first in-human trials by collaboratively drafting clinical protocols, IND applications, data safety monitoring plans, biostatistics, case report form creation for the capture of primary and secondary endpoints, access to a CTMS, electronic trial master file management (eTMF), PV-AE safety reporting and the full gamut of clinical trial management needs to effectively recruit and treat patients. The complete visibility of an asset’s clinical development pathway from early discovery to first in-human trial is a novel concept for outsourced pharma services.
Our team of experts ensures all GCP measures are met to ensure safety, compliance, and determination of clinical benefit or intended efficacy. We provide clinical staff, regulatory support, monitors, auditors, project managers, biostatisticians and data specialists to ensure the most secure and highest quality experience possible during the patients’ journey through the clinical trial.
Molecular Diagnostics and Immunology Research
The Discovery Labs has scaled up to form Testing Centers of America (TCA). The affiliate is located at The Innovation 411 site in King of Prussia, PA. TCA will serve as a center of excellence providing high throughput analysis supporting research and epidemiological studies critical to industry, academic and government clients. Offering a broad array of molecular, genetic and immunological test methods, TCA is able to rapidly process samples and develop data sets to establish an understanding of the human immune response to disease, potential biomarkers, and diagnostic tools which may be applied to foster health care and public health policy.
In fulfilling its mission to further research and public health, TCA employs cutting edge automation and molecular testing platforms to enable the efficient processing and analysis of samples on a monthly basis. Rigid protocols and processes ensure that chain of identity is maintained for all samples analyzed and results are collected and transferred in electronic format immediately following quality control verification to the client or agency sponsor.
The Discovery Labs
King of Prussia
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.
PRESS
Board of Directors
Marco Chacón, PhD
Chairman of the Board – Marco Chacón, PhD
“Setting the bar for the CDMO model”
Dr. Chacón is the Founder and former Chairman of Paragon Bioservices, Inc., a CDMO that specialized in process development and GMP manufacturing of viral vectors for gene therapy. In April of 2019 Paragon Bioservices, Inc. entered into a definitive agreement of sale for $1.2 billion with Catalent. Chacón is the Founder & President of IRAZÚ Bio-Holdings LLC., a company dedicated developing indications that promote survival, prevent disease and improve quality of life for the elderly. The company is also developing technology in the fields of immuno-oncology and gene therapy. Formerly, Chacón served as Assistant Vice President of Industry Alliances at the University of Maryland, Baltimore. His educational background includes a Bachelor of Science degree from Youngstown State University and a Ph.D. in Nutritional Sciences from the University of Maryland. He currently serves on the Board of Trustees of the University of Maryland Foundation and was appointed in 2016 to the Life Sciences Advisory Board by Governor Lawrence J. Hogan, Jr. Additionally, Dr. Chacón is the founding chair of The Board of Visitors of the University of Maryland Graduate School.
Brian O’Neill
Board of Directors – Brian O’Neill
“Investing with a higher purpose”
Mr. O’Neill is the Founder, Chairman and CEO of MLP Ventures, a leading venture capital and real estate investment firm. MLP Ventures creates companies that utilize real estate as an integral part of their business, as well as internet-based marketplaces. Under his leadership, MLP Ventures has developed millions of square feet of laboratory, office, industrial, retail and residential real estate throughout the Northeast. All of MLP companies and real estate recycle existing buildings, which often require environmental remediation. Mr. O’Neill has a track record of starting, scaling and operating healthcare organizations.
Alex Karnal
Board of Directors – Alex Karnal
“Healthcare initiatives for underserved communities”
Alexander Karnal is Partner and Managing Director at Deerfield and joined the Firm in 2005. He is responsible for portfolio decisions and allocations across the Deerfield Funds. Prior to Deerfield, Mr. Karnal worked as a member of Merrill Lynch’s Global Equity Linked Products Group and as a member of its Capital Markets team. He serves on the Boards of the New York Academy of Medicine, Biotechnology Innovation Organization, Recovery Centers of America and the Children’s Health Fund. He is a member of the Massachusetts Institute of Technology’s corporate development committee, focusing on student life initiatives. Mr. Karnal holds a B.S. from the Massachusetts Institute of Technology and M.S. from Johns Hopkins University.
Jack Stoddard
Board of Directors – Jack Stoddard
“Make primary care easier to access, insurance benefits simpler to understand and use and prescription drugs more affordable”
Mr. Stoddard most recently served as COO of Haven the healthcare collaboration from J.P. Morgan, Amazon and Berkshire Hathaway. Prior to this he served as an executive general manager for digital health at Comcast. Previously, he was on the founding team of Accolade, a Comcast Ventures-backed start-up that helps workers manage their health benefits. He was also part of the executive team that created claims processing engine Optum, which was later acquired by United Health. He is a senior operating leader with over two decades of experience applying technology, data, science, people, and design thinking to improve the healthcare consumer experience, elevate clinical quality and lower the total cost of care. He has proven leadership experience in understanding the market, setting growth strategy, and scaling transformational healthcare companies, including: Haven, Accolade, Optum, Health Dialog, and The Advisory Board. Jack holds an MBA from Harvard Business School and earned his bachelor’s degree at Denison University with highest honors. He serves on the boards of directors of Carrot, backed by Khosla Ventures and Eden Health, backed by Greycroft. He has also served on the Board of Trustees of the Philadelphia Outward Bound School.
Eustace Mita
Board of Directors – Eustace Mita
“Unwavering faith, always maintaining a positive attitude, how to be a leader, humility, and so much more.”
Mr. Mita is Chairman and Chief Executive Officer of Icona Resorts, which owns and manages hotel properties in Avalon, Diamond Beach and Cape May, New Jersey. Mr. Mita is also Chairman of Mita Management, a company with interests in automotive and real estate, and is the Chief Executive Officer of Achristavest, LLC, a developer of waterfront properties in New Jersey, Nantucket, Maryland, Utah and Pennsylvania. Prior to forming Mita Management and Achristavest, Mr. Mita was the President and Chief Executive Officer of HAC Group, one of the world’s largest auto dealer training and consulting groups, with operations in nineteen countries, including Europe and Asia. In 2000, under Mr. Mita’s leadership, HAC merged with Reynolds & Reynolds, which has approximately 5,000 employees and a network of 10,000 dealer customers worldwide.
Matthew McDevitt
Board of Directors – Matthew McDevitt
“As one of BioMed’s founders, Matt has been at the centre of our success in building a world-class tenant roster within every one of our seven core markets.”
Mr. McDevitt specializes in the leasing and sale of life-sciences real estate for tenants and landlords. Matthew founded and served as Executive Vice President of Real Estate for BioMed Realty Trust, Inc. where he played an instrumental role in all acquisitions and major lease transactions for the company. During his 10-year span, he maximized the shareholder value, growing its market capitalization from $475 million to $8 billion. Prior to BioMed, Matthew served as president of McDevitt Real Estate Services, Inc., a full-service real estate provider focusing on the life science industry. Before founding MRES, he spent 10 years as a commercial real estate broker in the Washington, D.C. Metropolitan area.
Tony Khoury
Board of Directors – Tony Khoury
“We raise awareness of many life-threatening diseases, but also bring our team and our client’s team closer to the actual patients that will be impacted by our work.”
Tony is a 15 year veteran and leader in the biotech and pharmaceutical industry. As a member of the Project Farma leadership committee, Tony has spearheaded Project Farma’s growth in the gene and cell therapy space including building gene therapy facilities for Avexis. Tony has extensive experience with small and large molecules including biologics, biosimilars, and gene and cell therapies. He has worked with small and large biotech companies including gene and cell therapy startups and CMOs/CROs. He has led global programs greater than $350+ million in the following disciplines: project management, turnkey facility builds, automation, validation, engineering and serialization track and trace.
Audrey Greenberg
Board of Directors – Audrey Greenberg
“There is a scarcity of manufacturing, which is complex, expensive, and highly regulated. With this additional manufacturing capacity, The Discovery Labs Center for Breakthrough Medicine will fulfill the promise of gene and cell therapies.”
Audrey Greenberg is the Co-founder and Executive Managing Director of The Discovery Labs, a global platform company streamlining the path to commercialization for ground-breaking pharmaceutical discoveries. The Discovery Labs includes several businesses including The Center for Breakthrough Medicines, Unite IQ, Testing Centers of America and DL Real Estate Specialty Services. Audrey is a member of the senior management team and board of directors where her efforts are focused on capital procurement, business formation, acquisitions, strategic planning and tactical execution. Audrey’s deep industry experience includes biotechnology, real estate, pharma services, and financial services.
Audrey started her career in public accounting at Deloitte & Touche in Chicago. Both before and after business school she was a Wall Street investment banker at Merrill Lynch and Morgan Stanley where she worked in the Financial Institutions Group doing M&A as well as debt financings and equity offerings. While at Morgan Stanley, she also worked on the fixed income trading floor specializing in high yield debt and derivatives. After a successful career in banking, she then ventured to the buy side to start a real estate private equity firm with three partners. Audrey oversaw a $7 billion open end core fund at ING Clarion ($50 billion AUM) and a $10 billion closed end fund series at CBRE Global Investors ($100+ billion AUM). She is an expert at REIT structures, off shore funds, tax strategies, financial structuring and capital introduction.
Audrey has a proven track record of spearheading multi-million dollar projects and transactions while simultaneously leading top-notch teams. Audrey has both strategic and tactical expertise in maximizing company value in businesses that support a greater social good, specifically in relation to health and wellbeing. Her experience includes launching several successful start-ups as well as growing businesses via organic and strategic growth. She has raised over $500 million for various ventures, managed over $10 billion in assets, and overseen and performed diligence on over $1 billion in acquisitions and spinoffs. She successfully brings socially-minded companies from idea to exit in a fruitful and expeditious manner.
Audrey is passionate about supporting her community and serves on several non-profit boards including the King of Prussia Business District, Har Zion Temple, the HSA at the NCCECE Preschool (also Treasurer) and the PTO at Radnor Elementary School (also Photographer). She is an active volunteer and has spent time as a Junior Achievement Coach, Mercy Home for Boys and Girls Friends First Mentor, United Way Crusade of Mercy Loaned Executive, and is currently an Emissary for Select Greater Philadelphia, a division of the Philadelphia Chamber of Commerce responsible for attracting business to Greater Philadelphia.
Audrey has her MBA in finance and management from the Wharton School where she was a member of the Wharton Wildmen Ice Hockey Team and the Wharton Women in Business Golf Team. Audrey has her undergraduate degree in accounting and finance and graduated with high honors from the University of Arizona. She was a member of the National Honor Society, Beta Alpha Psi National Accounting Honors Fraternity, Alpha Phi Sorority, and was on the Dean’s List. Audrey is a registered CPA in the state of Illinois. Most importantly, Audrey is the proud mother of three young children and enjoys spending time exploring Philadelphia with her family.
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