OCTANE CDMO
Safeguard Success
The Automation-First CDMO
cell therapies delivered to patients globally
medical devices manufactured
Protect Your Future Today
The advanced therapy landscape is complex and unforgiving. Every decision can either propel your therapy forward or set it back. To avoid costly delays, compliance roadblocks, and failure to reach market potential, you need a partner with a proven track record, deep expertise, and unwavering commitment.
Redefining What’s Possible in Cell Therapy
Octane exists on the cutting edge of cell therapy innovations and has the know-how, experience, technology, and systems to drive your vision forward with unmatched precision and expertise.
As an advanced therapy innovator, you seek advanced solutions. Octane equips you with cutting-edge automation, process optimization, and tools to push the boundaries of cell therapy.
“We are agile. Drawing on our expertise and tool sets, we will find the ideal solution to optimize your process and safeguard your vision.”
Gregory Nelson, COO
Unrivalled Experience
As the first CDMO to develop and commercialize two in-house advanced cell therapy products, we have lived what it takes to drive complex, personalized cell therapies from concept to profitable global commercialization.
Harness our hard-earned expertise in technology transfer, fully automated cell manufacturing, medical device development, and regulatory affairs to safeguard your cell therapy and propel it to global commercial success.
Fast-Track Your Path from Lab to Market
Let’s Take the
Journey Together
You have the innovative therapy. Octane CDMO has the development and manufacturing expertise in personalized, complex cell therapies.
Our team of 140 seasoned scientists, regulatory experts and manufacturing specialists is a highly efficient, automation-backed powerhouse that can run multiple projects simultaneously and deliver on a global scale. Together, we can bring your innovation to market, and to patients around the world.
Specializing in
Complex, Personalized Therapies
We specialize in personalized cell and blood therapies, with proven expertise in:
Tissue Engineering
Blood Products
Automated Cell Culture
Bioreactors
Bio Sensors
Bio Printing & Organ Printing
Gene Modification
Cell Transfection
Automation: From
Biopsy to Final Product
We’re the first CDMO to offer a fully closed automated cell manufacturing system—the Cocoon® Platform—which delivers comprehensive end-to-end solutions. Cocoon provides unique advantages for advanced therapy developers by integrating the highest number of sequential operations within a single automation platform, streamlining development and minimizing errors.
Be it with our system, or other leading automation systems, we’ll work with you to integrate automation early in the development process to save time, reduce costs, and prepare your therapy for scalable commercialization.
Automation Makes it Possible
Our advanced automation makes previously unviable solutions commercially feasible.
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Automation Makes it Profitable
Introducing automation concepts early accelerates your timeline and reduces costs down the line.
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Navigating Global
Regulatory and Development Landscapes
Navigating regulatory approval is complex, but with our experience, you’ll have greater peace of mind. As the only CDMO with two marketed cell therapy products and a global presence, we excel at managing relationships with regulators worldwide.
Expert Relationship Management
Our team routinely collaborates with local regulators to keep your project moving.
Proven Regulatory Success
We have a history of securing approvals from leading authorities like the FDA and EMA.
International Clinical Trials
We help set up and execute global clinical trials to ensure smooth completion.
Safeguard
Your Success
Our advanced cell therapy expertise, regulatory relationships and leadership in automation give you the edge to break through barriers and achieve exceptional results:
Safeguard Your Technology Transfer
Prevent costly missteps
Minimize delays
Minimize compliance issues
Reduce overall expenses
Seamless Technology Transfer
The highest product integrity and quality standards
Gain valuable time in the authorization process
Accelerate completion of clinical phases
Enable scalability for future growth
25+ Years of Driving Advancements
in Cell Therapy
With decades of experience, we have established ourselves as leaders in advanced cell and gene therapies. Here are just a few of the reasons why our partners trust us.
NOVOCART® INJECT
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Quality Systems
Our quality protocols help make sure you’re on the right track – before you get too far on your cell therapy development journey.
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Standards-Based Validation
The advanced therapy development pathway can be perilous. Reduce your risks with standards-based validation at every milestone.
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Regulatory and Clinical Coordination
We simplify your advanced cell therapy's cross-border challenges with leading regulatory and clinical coordination.
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International Presence
With CDMO facilities in Germany, USA and Canada, we are where you need us.
Germany
Reutlingen, BW
Canada
Kingston, ON
USA
Breinigsville, PA
CDMO
+
You
Connect with Octane CDMO Inc.
Safeguard every step of your advanced cell therapy journey to success.
Schedule a consultation with our experts at cdmo@octane.bio.
