Manufacturing

Manufacturing

When Inceptor Bio was conceptualized, it was with a vision to develop cell and gene therapies that cure difficult-to-treat cancers. An Advanced Manufacturing Platform – or AMP+ as we call it – is central to this vision and our strategy. AMP+ is our new, world-class, highly flexible GMP manufacturing facility located in Gainesville, Florida, and it represents a key differentiator for Inceptor Bio as it enables the manufacturing of multiple effector cell types, alleviating a major bottleneck for cell therapies – access to early-phase manufacturing. The facility features the latest technology and is run by a dedicated, passionate, and highly experienced team.

While more manufacturing capacity in cell & gene therapy has been coming online rapidly over the past five years, access to manufacturing for Phase I and II clinical materials remains scarce. This promotes high costs, long lead-times, and adds unnecessary risk to development projects. We have addressed this issue with AMP+, enabling Inceptor Bio to execute on bringing innovative new cures to cancer patients.

• 29,250 square foot site with four buildings
• 6 GMP Suites – Grades C and D
• Suites available for inoculium prep, small-scale processing, or cell banking
• Dedicated media/buffer prep area
• Dedicated stability area
• In-process and EM micro-QC labs

Process and Manufacturing Expertise

Inceptor Bio’s AMP+ team are experts on our platform process, enabling robust process design, clinical manufacturing, and tech transfer for commercial supply.

Costs Optimization for Multiple Programs

Our expertise in PD / AD and manufacturing will be shared across assets, creating a shared infrastructure and efficient platform.

Speed to Clinic

AMP+ enhances the speed of production for clinical material, delivering medicines in an expedited manner.

Flexibility and Control over Critical Operations

Inceptor Bio maintains control over mastering PD / AD and moving product candidates into the clinic.

Next-Generation Manufacturing Platforms

We are invested in next-generation manufacturing platforms to stay at the forefront of innovative manufacturing technologies.

In harmony with AMP+, Inceptor Bio has expanded our cell & gene therapy R&D capability with a larger facility in Research Triangle Park (RTP), North Carolina, creating more space for our expert team to support programs and partners in advancing into clinical manufacturing.

RTP is an economic and manufacturing hub for cell and gene therapy in the United States, and was chosen as the home of Inceptor Bio partly because of the depth of talent that can drive research productivity and innovation. Our experienced and knowledgeable R&D team works seamlessly with partners to optimize programs and move them quickly through the phases of development towards commercialization.

Across our R&D team and the AMP+ team in Gainesville, we offer class-leading expertise in:

AMP_Core3

Cell & Gene Therapy Manufacturing

Process Development

Process Development

Product Development

Product Development

expertise4-1

Regulatory Affairs

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Quality Systems

Chemistry, Manufacturing & Controls (CMC)

Chemistry, Manufacturing & Controls (CMC)

expertise7-1

Analytical Chemistry

expertise8-1

Facilities

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Project Management

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