AIM - ANALYSIS OF IMMUNE MODULATION

Makrolife Biotech is the official European laboratory for AIM testing – an innovative immunological test method from the U.S. designed to analyze the immune response of healthcare products. The AIM test is cruelty-free, precise, and scientifically validated, offering a modern solution for evidence-based product testing.

AIM – Your scientifically validated, animal-free testing method for safe and regulatory-compliant immune modulation
Applicable across cosmetics, pharmaceuticals, and dietary supplements.


Immunologically Tested – with AIM

Makrolife Biotech offers AIM analyses.

Immunologically Tested – with AIM
AIM stands for Analysis of Immune Modulation and is an innovative testing method developed in the USA to assess the immunological effects of active ingredients, formulations, and products. The test analyzes how the immune system – particularly human macrophages – responds to a product.


Makrolife Biotech is the official AIM laboratory in Europe and performs these tests under controlled laboratory conditions – entirely animal-free, scientifically documented, and regulatory-relevant. AIM is based on the evaluation of functional immune responses, such as cytokine production (e.g., IL-6, TNF-α, IL-10), macrophage polarization (M1/M2), and other markers of inflammation and regenerative processes.


This method is particularly suitable for companies in the following sectors:

  • Dietary supplements
  • Cosmetics and dermocosmetics
  • Biopharmaceuticals and plant-based actives
  • Skin regeneration, immune modulation, and anti-aging


Complies with:

  • EU Regulation No. 1924/2006 (Health Claims)
  • EU Regulation No. 1223/2009 (Cosmetics)
  • EU Regulation No. 2015/2283 (Novel Food)
  • REACH / CLP / OECD TG 442E


AIM - Immunological Analyses

Cruelty-Free:
AIM uses only human immune cells (macrophages) – no animal models involved.


Master Cells of the Immune System:
Macrophages are central regulators of immune responses, enabling a particularly meaningful and accurate analysis.


Measurable Immune Reaction:
AIM evaluates functional immune markers such as cytokine profiles, macrophage polarization (M1/M2), and immunorelevant signaling pathways.


Scientifically & Regulatory Relevant:
AIM data are objective, reproducible, and suitable for research, regulatory submissions, and product development.


International Origins – Local Expertise:
Developed in the USA, AIM is now offered in Europe exclusively by Makrolife Biotech as an official partner lab.


Customizable & Transparent:
Each test is individually tailored to your product and includes a complete report with scientific interpretation.

AIM-tested

Immunologically Tested with the AIM Method (Analysis of Immune Modulation) –  conducted at Makrolife Biotech under GLP-like quality standards.
 
Cruelty-free. Human-relevant. Regulatory-backed.

Dietary Supplements & Health Claims (EU & USA)

(EU) Regulation No. 1924/2006 – Health Claims

This regulation governs health-related statements such as “supports the immune system.”


Relevance to AIM:


AIM provides precise in-vitro data on immune modulation (e.g., cytokine profiling, M1/M2 polarization).


These data are accepted as part of the scientific substantiation in EFSA dossiers.


Recommended as a component of a Comprehensive Scientific Substantiation Package.


Under EU Regulation (EC) No. 1924/2006, AIM can be used as a scientifically robust part of a dossier submitted to EFSA, especially for novel immune-related claims on dietary supplements and functional ingredients.


AIM testing delivers reliable, scientifically validated data to support claims such as:


“Contributes to the normal function of the immune system”


“Exerts anti-inflammatory effects”


“Supports cellular immune response”


“Promotes immunoregulatory balance (M1/M2)”


These claims can be prepared and supported with AIM data for regulatory submissions, including EFSA dossiers and FDA structure/function claim substantiation.



Regulatory Compliance

Allows “Structure/Function” Claims such as “supports immune health.”

Relevance to AIM:


The FDA requires substantial scientific evidence for these claims.


AIM provides high-quality, human cell-based in-vitro data on immune activity.


Particularly relevant for dietary supplements targeting the U.S. market.


AIM complies with the requirements of multiple regulatory frameworks:


EU Regulation No. 1924/2006 (Health Claims)


EU Regulation No. 1223/2009 (Cosmetics)


EU Regulation No. 2015/2283 (Novel Food)


REACH / CLP / OECD TG 442E (Safety Assessments)


AIM supports the preparation of compliant dossiers for functional products, cosmetics, and novel foods, ensuring scientific validity and regulatory readiness.



International Applicability

Makrolife Biotech supports you in marketing your products by developing tailored communication strategies that directly engage your target audiences. We create fully usable marketing visuals that clearly present your scientific data and demonstrate your product’s functionality.


FDA / DSHEA (USA)

AIM data can be used in GRAS notifications and to support structure/function claims for dietary supplements in the U.S. market.

Example claim: “Supports healthy immune function” — substantiated by AIM data from macrophage analyses and cytokine profiling.


ICH Guidelines (Pharmaceutical Industry)

AIM is compatible with ICH guidelines for preclinical immunotoxicity studies, including assessment of:


Immune activation and suppression


Cytokine Release Syndrome (CRS)


Interactions with the innate immune system


This makes AIM suitable for pharmaceutical development programs, especially in the areas of biologics, botanical extracts, and immunoactive therapeutics.


AIM is internationally applicable:

EU: Health Claims, Novel Foods, Cosmetics


USA: GRAS, DSHEA, FDA-compliant structure/function claims


ICH: Immunotoxicology in pharmaceutical development


The AIM method is designed for global markets and aligns with regulatory requirements across multiple continents.



Animal-Free In-Vitro Testing & REACH Compliance

OECD Guidelines & ECVAM

The AIM test complements existing OECD test guidelines (e.g., 442E, 431, 439, 497) by incorporating immunological endpoints.


Relevance to AIM:


In-vitro validation based on functional immune cell responses


No animal models required


Ethical, reproducible, and regulatorily accepted


EU Animal Testing Ban (Cosmetics)

Since 2013, the EU prohibits marketing cosmetic products tested on animals.


Relevance to AIM:


AIM meets the requirements for animal-free alternatives


Complements classical cell line models with functional immune response data


AIM as an Ethical Alternative to Animal-Based Immune Analyses

100% in-vitro


Uses primary human immune cells


Compliant with ECVAM and OECD recommendations


AIM also meets the expectations of modern consumers and brands regarding sustainability, animal welfare, and scientific ethics.



Novel Foods & Functional ingredients

Regulation (EU) 2015/2283 – Novel Food

The Novel Food Regulation (EU) 2015/2283 requires new food ingredients to be evaluated for safety and functionality, especially relevant for novel plant-based or fermented ingredients with immunological effects.


Relevance to AIM:


AIM testing provides preclinical efficacy and safety data that can be used as part of a Novel Food application.


It delivers immunological data on activity, tolerability, and modulation.


DSHEA (USA) – Dietary Supplement Health and Education Act

Allows structure/function claims such as “supports immune health.”


Relevance to AIM:


The FDA requires substantial scientific evidence to support these claims.


AIM offers high-quality, human cell-based in-vitro data on immune activity.


Particularly relevant for dietary supplements targeting the U.S. market.



Regulatorische Einordnung & Kosmetik Verordnung

AIM testing provides precise in-vitro data on immune system modulation by specific substances, serving as a scientific basis for the following health-related claims:


“Contributes to the normal function of the immune system”


“Exerts anti-inflammatory effects”


“Supports cellular immune response”


“Inhibits pro-inflammatory processes”


“Reduces oxidative or immune-mediated cellular damage”


“Promotes immunoregulatory balance (M1/M2 ratio)”


These claims can be substantiated using AIM data obtained from primary human macrophages and prepared for regulatory dossiers. This method offers a functional, cruelty-free alternative to traditional health claim substantiation.


Cosmetics Regulation (EC) No. 1223/2009

Cosmetic products with anti-inflammatory or skin-soothing effects must be supported by scientific evidence. AIM provides a valid, human-relevant proof for claims such as “soothes the skin,” “reduces irritation,” and “supports skin regeneration.”