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Viral Product Services
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We provide dedicated BSL-2 production services for attenuated and inactivated viral vaccines as well as live challenge virus strains.
- Adherent Upstream Processing: We support large-scale cell growth using fixed bed bioreactors (equivalent to 120-360 roller bottles) as well as traditional roller bottle and cell stack methods
- Viral Banking: Creation of Master/Working viral banks (up to 200 vials each).
- Strain Production: We can produce live challenge viral strain
- Containment: Our viral suite features independent air handling and Vaporized Hydrogen Peroxide (VHP) decontamination to ensure a closed, sterile environment for every campaign.
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Non-Viral Services
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Our facility supports a broad range of non-viral production needs.
Microbial Services
- Fermentation & Culture: We offer microbial fermentation from 1L to 400L scale and mammalian cell culture up to 40L scale (with plans to support up to 500L in 2028)
- Cell Banking: Creation of Master/Working cell banks (up to 200 vials each).
- Bacterial Production: Services include the production of bacterial challenge strains and live attenuated bacterial vaccines
- Harvest: We utilize scalable equipment like a stacked disk centrifuge and tangential flow and depth filtration systems for efficient product separation and purification.
mRNA Production Services
Our facility is equipped for modern mRNA production capability, including in vitro transcription services with an approximate output of 1 gram of mRNA (up to 300 mL IVT scale).
We offer lipid nanoparticle (LNP) encapsulation & liposome production services.
Purification Services
We offer expert, scalable purification for recombinant proteins, mRNA, and other products, utilizing a range of techniques:
- Depth Filtration
- Chromatography
- Tangential Flow Filtration (TFF)
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Fill & Finish Services
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Our team can take your product to the final step with our formulation and filling services.
- We provide formulation for both viral and non-viral drug products.
- Our aseptic fill finish service includes manual filling for lots of up to 2,000 vials, qualified for vial sizes from 2mL to 20mL.
- We offer lyophilization (freeze-drying) capabilities to improve the stability and shelf-life of your final product.
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Quality & Analytical Services
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Our quality control and analytical teams provide critical support throughout the entire manufacturing lifecycle.
- Our services include in-process quality testing during manufacturing and analytical testing for product release.
- Stability Testing: We conduct stability testing for both Drug Substance and Drug Product to establish shelf-life and storage conditions.
- Process & Analytical Development: Our team provides process scalability assessments, manufacturing process development, technology transfer, and the development of product-specific analytical tests.
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