Discussion of Biosafety Issues arise in Human Study

1. Human Biosafety Issues of
Nanomaterials used as Nanomedicine
Presented by Ahmed Madni
Ph.D. Student
NIBGE-College (PIEAS)

2. Introduction
• Nanomedicine
“Nanomedicine is the medical application of nanotechnology
(nanomaterials)”
• This field involves diagnosing, treating and preventing disease and
traumatic injuries
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3. Introduction
• Nanomaterials: Materials possessing, at minimum, one external
dimension measuring 1-100 nm. It can be used as image agents or
therapeutic drugs, gene delivery, and/or biological devices,
nanoelectronic biosensors or molecular nanotechnology
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4. Introduction
Properties of Nanomaterials
• Small size
• Surface area
• Catalytic properties
• Optical properties
• Higher specific heat and thermal expansion
• Higher conductivity
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5. Why Issues have been Raised
• As the composition, morphology, chemical properties, implant sites as
well as potential applications become more and more complex, human
biosafety of nanomaterials for clinical use has become a major
concern. If nanoparticles accumulate in the human body or interact
with the body molecules or chemical components, health risks may
also occur
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6. Human Biosafety Issues
Major concerns that have been observed
• First, NPs possess different physicochemical properties compared to their
bulk analogues due to extremely small size and large surface area, which
makes the particles more reactive and catalytic
• Second, in the field of nanomedicine, exogenous NPs may be delivered into
the human body without passing through the normal gastrointestinal
absorption process after intravenous or interstitial injections
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7. Human Biosafety Issues
• Third, in the human body, NPs have the potential to interact with
biological molecules or to accumulate in human tissues or organs
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8. Human Biosafety Issues
1) Relying on in vitro and in vivo test
• Most published data related to nanomaterial products in nanomedicine are
still staying at in vitro cell culture or in vivo animal experiment stages
• Human clinical trials should be the last but the most important step for
clinical translation of nanomaterial products. However, the transition
probability might be low because clinical translation in nanomedicine is a
long, arduous, resource intensive process
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9. Human Biosafety Issues
2) Focusing on effectiveness with no biosafety evaluation
• Most of them focused mainly on reporting the findings of the therapeutic effectiveness of the
nanodrugs, but not on evaluating the human biosafety of the nanomaterials
• Most nanomedicine products approved for clinical use are from soft NPs. Moreover, a large
proportion of the soft NPs are composed of liposomal and polymer-conjugated formulations.
Although soft NPs are relatively low toxicity, large counterparts may accumulate in vital organs
and cause toxic problems, while solid nanoparticles were used for diagnostic imaging
• Although all the materials assigned for clinical trials have demonstrated biocompatibility using
current standards, it remains unclear whether persistence in the human body will produce acute
or chronic adverse effects
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10. Human Biosafety Issues
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11. Human Biosafety Issues
3) Assessment methods in Animals
• In animal experimentation, generally high dose and short exposure time is
assessed, which is quite different from human administration routes in clinical
practice
• In addition, due to the profound differences in anatomy, physiology and
genetics between humans and animals, results from animal experiments cannot
directly be extrapolated to humans, and in most instances, animals have been
poor predictors for how humans will respond to drugs
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12. Other Challenges
• Regulatory issue
US Food and Drug Administration, National Institutes of Health, Swiss
Agency for Therapeutic Products, the European Union, Drug Regulatory
Authority of Pakistan
• Environmental issue
• Social issue
• Ethical issue
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13. Future Outlook
• Theranostic NP
• Organ-on-a-chip evaluation procedure
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