The ATMP 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.
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 ATMP innovator, you seek advanced solutions. Octane equips you with cutting-edge automation, process optimization, and tools to push the boundaries of cell therapy.
As the first CDMO to develop and commercialize two in-house ATMPs, 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 ATMP and propel it to global commercial success.
You have the innovative ATMP. 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.
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
We're the first CDMO to offer a fully closed automated cell manufacturing system—the Cocoon Automated Bioreactor—which delivers comprehensive end-to-end solutions. The Cocoon provides unique advantages for ATMP 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.
Our advanced automation makes previously unviable solutions commercially feasible.
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Introducing automation concepts early accelerates your timeline and reduces costs down the line.
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Navigating regulatory approval is complex, but with our experience, you’ll have greater peace of mind. As the only CDMO with two marketed ATMPs and a global presence, we excel at managing relationships with regulators worldwide.
Our team routinely collaborates with local regulators to keep your project moving.
We have a history of securing approvals from leading authorities like the FDA and EMA.
We help set up and execute global clinical trials to ensure smooth completion.
Our ATMP expertise, regulatory relationships and leadership in automation give you the edge to break through barriers and achieve exceptional results:
Prevent costly missteps
Minimize delays
Minimize compliance issues
Reduce overall expenses
The highest product integrity and quality standards
Gain valuable time in the authorization process
Accelerate completion of clinical phases
Enable scalability for future growth
With CDMO facilities in Germany, USA and Canada, we are where you need us.
Reutlingen, BW
Kingston, ON
Breinigsville, PA
Safeguard every step of your ATMP’s journey to success.
Schedule a consultation with our experts at cdmo@octaneco.com.
Get more capacity from the same infrastructure, lower production labour costs, and optimize your raw materials. Octane has built-in automation expertise to help you realize economies of scale and efficiency from early-stage to commercialization.
With the right partner, early automation can drive faster model translation and accelerate your development timeline. Automating from the start also means you won’t need to revalidate manual processes later, leading to significant savings that can add to your profits.
Our processes are fully documented according to our Quality System, which meets the requirements of the U.S. Food and Drug Administration, Health Canada and the European Medicines Agency and is certified to ISO 13485 and ISO 9001 standards. We provide complete audit-ready documentation of your ATMP’s full development and production history – from design and manufacturing to labeling and performance. Our facility includes Containment Level I and II biology labs where we can perform comprehensive cell and tissue evaluations.
From developing Validation Master Plans to delivering validation protocols, we apply our extensive experience in risk management and GMP manufacturing to ensure your ATMP consistently meets specifications and regulations. Our approach is methodical – and reliable at every development milestone.
Getting your ATMP through clinical trials and into commercialization is easier and faster with Octane. We have the systems, expertise and international relationships needed to set up and coordinate clinical trials, obtain regulatory approvals and register your ATMP.