Novex Innovations
Biologics & Tissue Division
Our Capabilities
Our capabilities, manufacturing, and technology solutions include:
If you’re looking at transferring your program from another organization or moving from a development phase to the steps of commercialization, we have the resources to implement a plan that can accommodate your timelines.
Our tissue processing operations are carried out under cGMP to ensure the best possible control over your processing.
Bioengineered tissue and cell propagation are handled under regulated operational procedures ensuring control of cell lines and reproducibility of manufacturing steps.
Taking the research and development that has been generated we create a development path that is geared to a commercial outcome. We leverage our internal in-process capabilities and our 3rd party analytical support for method development and release testing.
All operations are under cGMP manufacturing, ensuring the appropriate controls required specifically for your project. With our four ISO 5 cleanrooms and two additional units under development, we are able to manufacture under the appropriate level of environmental controls suited for your program.
All manufacturing is completed with a batch record for parameter control and reproducibility.
From automation to manual operations, we support manufacturing from the smallest batch requirements to scaled up requirements.
We provide support for all manufacturing activities from material evaluation to commercialization and every stage in-between.
FDA Registered.
AATB accreditation process underway.
Currently registered as the sole manufacturers for 3 IND/BLA and 3 under development.
Listed as the manufacturer for a product in Japan, undergoing review for PMDA applications.
Looking for expert biologics and tissue solutions?
We’re a reliable, experienced, and adaptive partner with expertise in biologics. Let’s start a conversation about what you need.
