- Clinical Development
- Custom Product Design & Formulation
- Assay Development
- Regulatory Support
Approximately 30% of IND applications are placed on hold due to CMC issues. Don’t let this happen to you!
Streamline the Time to Submission and Approval or Clearance
From the early stages of product development, through to market authorization, Akron works closely with clients to develop effective regulatory drug development strategies for advanced biological therapies. Akron has extensive knowledge and experience in U.S. and international regulatory affairs, with a proven track record in achieving approvals.
All clinical applications and devices involving stem cells are regulated at some level. In most countries, if not all, the use of minimally manipulated autologous stem cell implantation is regulated by the local or hospital ethics committee, or both. Exempt from FDA regulation are vascularized human organs for transplantation, autologous products reimplanted during the same surgical procedure, minimally manipulated marrow for homologous use, or reproductive cells implanted into the partner of the donor.
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Stem Cell Drug Substance is Special
Unlike small-molecule pharmaceuticals, cells and stem cells are living entities that cannot be chemically synthesized. Therefore, unique considerations must be given to the donor and the source of the cells, and to subsequent processing. The most significant difference between small-molecule pharmaceutical development and stem cells is the definition of Drug Substance (DS). Drug Substance means an active ingredient that is intended to furnish pharmacological activity.
If the DS is a stem cell or cell, the DS includes intermediates that are used in the synthesis of such an ingredient. In practice, this means that any reagent or agent coming into contact with the cell during the product development lifecycle is considered the drug substance. For this reason, it is important to work closely with Akron from the beginning, and to define your needs and goals and the reagents you will be using.
Regulatory Strategy, Filing, and Support
Human Cells, Tissues, and Cellular and Tissue-Based Products (
- Strategic support and scientific rationale
- A well-developed, controlled manufacturing plan
- Data on product characterization
- Data to support specifications for the product's quality control and release