Regulating Hybrids: 'Making a Mess' and 'Cleaning Up' in Tissue Engineering and Transpecies Transplantation.

Area of Science:

• Biosciences
• Regulatory Science
• Biotechnology

Background:

• Novel biosciences, particularly hybrid technologies, challenge existing regulatory frameworks.
• Human tissue engineering (TE) and xenotransplantation (XT) are examples of such innovations.
• Regulators have attempted to govern TE and XT separately, creating distinct institutional boundaries.

Purpose of the Study:

• To explore the institutional regulation of novel biosciences.
• To develop a conceptual vocabulary for understanding material and institutional hybrids.
• To compare the regulatory approaches to human tissue engineering and xenotransplantation.

Main Methods:

• Comparative analysis of regulatory frameworks for TE and XT.
• Conceptual analysis of material and institutional hybrids in biosciences.
• Examination of the practical and material overlaps between TE and XT.

Main Results:

• Despite regulatory attempts at separation, TE and XT exhibit significant practical and material interconnectedness.
• Human and animal biological materials and products are more closely linked than institutional boundaries acknowledge.
• This interconnectedness creates instability in the regulation of implants and transplants.

Conclusions:

• Existing regulatory frameworks are ill-equipped to handle the hybrid nature of novel biosciences.
• The "purification" attempts by regulators are challenged by the corporeal realities of TE and XT.
• There is a need for adaptive regulatory strategies that acknowledge and manage the inherent hybridity of these technologies.