Offering scalable &
multi-modal cGMP solutions
Cell & Gene Therapy
Advanced Therapeutics
Biologics
Biopharmaceuticals
Chemical Manufacturing
GeneSuites offers purpose-built cGMP manufacturing High-Performance Shell (HPS) and Suite Solutions with supporting infrastructure so that customers can occupy the space, install their process equipment, start their facility prior to clinical manufacturing with the option to launch their commercial product all under one roof.
High-Performance Shell (HPS)
Designed for companies seeking maximum flexibility with accelerated speed to market. Facility comes equipped with cGMP-specific infrastructure such as boilers, chillers, electrical and additional components, beyond the offering of a typical industry cold shell. HPS remains flexible enough to support customer-specific improvements while providing a time savings of over 12 months.
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GeneSuites' flagship project, Catalyst BioCampus in North Carolina, includes HPS as one of its offerings: Learn More
Suite Solution
Much like the advantages of a turnkey lab space, the GeneSuites Suite Solution offers customers immense speed-to-market advantages with built-out cleanrooms, warehouse, PD, lab, and office/admin space ranging around 40,000 SF. Given the modular design of the cGMP facility, the suites are scalable and can be the perfect solution for early-to-mid stage companies.
For more information, please contact us.
Comparing Existing cGMP Biomanufacturing Solutions with GeneSuites
Build
cGMP Capacity
in-house
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Capital intensive
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Long-lead time to select site, design and build facility
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Resource intensive to build internal construction/design team
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May be less attainable for early-stage companies
Buy
cGMP Capacity
via Contract Mfg (outsource)
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Can be cost-effective in the short term
-
Dependent on available capacity and CDMO/CMO expertise, may require waitlist
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Requires tech transfer, minimizing control over IP
GeneSuites
Hybrid cGMP
via HPS & Suite Solutions
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Significantly lower upfront capital expenditures
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Achieve quicker time to market than Build solution
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Maximize IP and process control compared to Buy solution
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Avoid significant internal staff-up
The GeneSuites Advantage
Expert
cGMP Team
Combining cGMP, financing, and real estate expertise to develop solutions that remove existing barriers for biomanufacturing
Modular & Standardized Design
Ability to accommodate multiple therapies, processes and technologies within the same facility with separate infrastructure
Accelerate
Speed to Market
Quicker time to market than internal Build solution;Potentially faster start than Buy (Contract Manufacturing)
Maximize
IP & Quality Control
Maximize control of intellectual property, process, methodologies, and tech transfers
Lower Upfront Capital Outlay
Enables companies to focus investment on science and clinical execution in earlier phase of development
Leverage
Scalability
Can accommodate pre-clinical through commercial scale
High-Performance Shell:
First of its Kind in North Carolina
Purpose-built cGMP Biomanufacturing Campus
In partnership with affiliates of Apollo Global Management, GeneSuites is developing Catalyst BioCampus, a three-building cGMP biomanufacturing campus located in Raleigh-Durham, NC.
Catalyst BioCampus is designed to accelerate critical manufacturing capacity for cell & gene therapy, monoclonal antibody – as well as other modalities – by 9-15 months.
Expanding Across Major Life Science Markets
GeneSuites has entered the Raleigh-Durham market with Catalyst BioCampus and will continue to expand across major life science markets in the United States and abroad.
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Over 300,000 SF of purpose-built cGMP space at Catalyst is under construction and is ready for tenant fit-out.
