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OneBio® Integrated Suite

The biologics market is experiencing high growth. However, the path to clinic for biologics is complex, requiring a substantial amount of time and resources to ensure success. Sponsor companies are looking for an “all of the above” solution, where they don’t have to trade speed for risk while managing multiple development partners.

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OneBio Integrated Suite is a single solution from cell line development through clinical supply to reduce timelines, risk and complexity, which leverages Catalent’s Follow the Molecule® approach for an accelerated solution. OneBio is designed specifically for those looking for:

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SPEEDTo clinic or market
SIMPLICITYWith fewer internal resource needs
REDUCED RISKOf rework and issues
EXPERTISETo enable the best chance of success

OneBio has the potential to save time through the development process:

Streamlined Documentation
Single proposal
Reduced time negotiating contracts
Finely-tuned, tested process

Parallel Processing
Project plan and approval
Batch records
Equipment, materials & validation testing

Improved Planning
Kick-off call with drug substance, drug product and clinical supply stakeholders
Secure timely manufacturing slots
Forecast clinical trial supply needs

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We have the passion to help you accelerate, simplify and de-risk your next biologic from development and manufacturing, to fill/finish, clinical supply and commercial launch.

GPEx® Cell Line Development
Create stable, high-yielding mammalian cell lines for even the most difficult to express proteins with proven GPEx technology.

Biologics Analytical Services
Comprehensive integrated solutions for drug substance, drug product and intermediates with support from pre-clinical testing through commercial release and stability.

Development & Biomanufacturing
State-of-the-art facilities offering right scale flexible clinical and commercial manufacturing, integrated process development, and analytical services to solve your most difficult development and biomanufacturing challenges.

Drug Product Fill/Finish
Flexible solutions for vial, syringe and cartridge filling based on specific needs with integrated formulation development and packaging capabilities, including safety device and auto-injector assembly with full analytical support.

Clinical Supply Services
Comprehensive clinical supply services including commercial drug sourcing, prefilled syringe finishing, extensive cold chain capabilities and global distribution.

Cell & Gene Therapy
Industry-leading technology, development, and manufacturing partner for advanced therapeutics. A full-service CDMO partner for plasmid DNA, viral vectors, vaccines, iPSCs, and autologous and allogeneic cell therapies, Catalent has a global network of development through commercial-scale manufacturing facilities in the U.S. and Europe.